On May 13, 2020 Biocept, Inc. (NASDAQ: BIOC), a leading provider of molecular technologies designed to provide physicians with clinically actionable information to improve the outcomes of patients diagnosed with cancer, reported financial results for the three months ended March 31, 2020 and provides an update on its business progress (Press release, Biocept, MAY 13, 2020, View Source [SID1234557953]).

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"Revenue for the first quarter was $1.4 million, representing a 41% increase over the prior-year period driven by a 27% increase in revenue per commercial accession," said Michael Nall, President and CEO of Biocept. "We increased revenues even with the headwinds of the COVID-19 pandemic, which we estimate led to an approximate 15-25% decline in commercial volume from current customers and also impacted opportunities for us to gain new customers with the closing of many physician offices and labs. Operational efficiencies contributed to progress toward our goal of positive gross margin resulting in a 50 percentage point improvement versus the prior-year period. These efficiencies are primarily related to automation of our lab, with additional actions yet to be taken this year.

"Importantly, we believe we are well positioned to weather the pandemic, which is impacting testing volume industrywide, and for a return to growth as shelter-in-place restrictions are lifted and physician offices and labs reopen," he added. "We are an established leader in liquid biopsy and our Target Selector assays and products provide critical information to physicians in treatment decision-making. We expect that when it is safe for patients diagnosed with cancer to continue to seek treatment, our commercial volume will return to a more normal level. We are particularly pleased with our strengthened balance sheet, having raised approximately $36.3 million in net proceeds since the beginning of December 2019. While we believe that based on historical and planned cash usage, our current funding is expected to support operations through most of 2021; however, with the uncertainty introduced by the impact of COVID-19 on revenue and collections, our cash runway may be shorter."

First Quarter 2020 and Recent Highlights

Commercial Launches

Announced the availability of Target Selector assays to evaluate cerebrospinal fluid (CSF) for the presence of circulating tumor cells (CTCs) and biomarkers, which may be indicators of brain metastases. Of patients diagnosed with breast and lung cancer, up to 30% and 36%, respectively, will develop brain metastases. The validations study for our CSF assay was conducted in collaboration with Providence St. Joseph Health, Southern California, and its wholly owned affiliates Providence St. John’s Health Center and John Wayne Cancer Institute.
Launched the availability of research-use-only (RUO) kits that allow molecular laboratories worldwide to detect oncogene mutations through the analysis of both Formalin-Fixed Paraffin-Embedded (FFPE) tissue gained from surgical biopsies as well as circulating tumor DNA (ctDNA) gained from blood-based liquid biopsies. The first RUO kit with the ability to use tissue and liquid biopsy samples is designed for the detection of EGFR mutations that are among the most frequently evaluated biomarkers of lung cancer. RUO kits for other oncogene mutations are planned for future launches.
Awarded CE-IVD Mark for the Target Selector molecular assay EGFR Kit. The CE Mark confirms that Target Selector kits meet the requirements of the European In-Vitro Diagnostic Devices Directive and allows Biocept to commercialize these kits throughout the European Union and other CE Mark geographies. Molecular assay kits detect key oncogene mutations through the analysis of both FFPE tissue as well as ctDNA. The EGFR pathway can include mutations that are among the most frequently evaluated biomarkers for lung cancer.
Announced the validation for COVID-19 testing. Biocept operates a high-complexity, CLIA-certified, CAP-accredited and BSL-2 safety level laboratory in San Diego, with specialized, licensed molecular lab staff who have been trained in performing the COVID-19 testing. The lab will be using ThermoFisher Scientific’s FDA-approved for EUA (Emergency Use Authorization) testing TaqPath molecular diagnostic platform and kit for SARS-CoV-2 (COVID-19). Due to the national shortage, Biocept’s clients have had difficulty gaining specimen collection kits to send to Biocept for testing and to date, we have not been able to perform any COVID 19 testing. In order to address this and provide needed testing, Biocept intends to manufacture its own collection kits for distribution to clients and expects those kits to be available in June.
Commercial Agreements

Signed laboratory services agreements with two large California-based independent physician associations (IPAs) to provide Biocept’s Target Selector liquid biopsy testing services.
Peer-reviewed Journal Publications

Announced publication of clinical data in the Journal of Clinical Pathology that further validates Biocept’s Target Selector qPCR Assay using Switch Blocker technology to identify cancer-related mutations in liquid biopsy samples. Study results showed a very high concordance between Biocept’s liquid biopsy testing and tissue biopsy and best-in-class detection of alterations down to a single mutant copy in both analytical and clinical settings.
Intellectual Property

Awarded U.S. patent covering antibody and microchannel technology and enhanced detection of cancer cells. This new patent expands Biocept’s intellectual property estate for capturing and detecting rare cells of interest, including CTCs, to aid in the management of patients with cancer.
Granted Australian and Brazilian patents providing intellectual property protection for its Primer Switch technology that is useful for ctDNA analysis using reverse-transcription PCR and associated methods, including next-generation sequencing (NGS).
Corporate Developments

Promoted Cory J. Dunn to Senior Vice President of Commercial Operations. Ms. Dunn joined Biocept as Vice President of Marketing in October 2018.
First Quarter Financial Results

Revenues for the first quarter of 2020 were $1.4 million, a 41% increase from $1.0 million for the first quarter of 2019. Revenues for the first quarter of 2020 included $1.3 million in commercial test revenue, $60,000 in development services test revenue, and $69,000 in revenue for distributed products, Target Selector RUO kits and CEE-Sure blood collection tubes. Revenues for the first quarter of 2019 included $976,000 in commercial test revenues, $42,000 in development services test revenues and $5,000 from RUO kits and blood collection tubes.

Biocept accessioned 1,306 total samples during the first quarter of 2020, compared with 1,325 total samples during the first quarter of 2019. The Company accessioned 1,141 billable samples during the first quarter of 2020 compared with 1,155 billable samples during the first quarter of 2019. We believe that the decline in total samples and billable samples was due to the impact of the COVID-19 pandemic.

Cost of revenues for the first quarter of 2020 was $2.9 million, compared with $2.6 million for the first quarter of 2019. Cost of revenues increased 13% while revenues increased by 41% as Biocept continued to leverage its fixed costs.

Research and development (R&D) expenses for the first quarter of 2020 were $1.3 million, compared with $1.2 million for the first quarter of 2019, with the increase primarily due to development and validation costs related to additional offerings, such as validation of CSF and COVID-19 assays. General and administrative (G&A) expenses for the first quarter of 2020 were $1.9 million, compared with $1.7 million for the first quarter of 2019, with the increase due mainly to a reclassification of certain customer service and related expenses from sales and marketing to G&A. Sales and marketing expenses for the first quarter of 2020 were $1.5 million, compared with $1.4 million for the first quarter of 2019, with the increase primarily attributed to commission on higher revenue.

Other expense, net for the first quarter of 2020 was $2.2 million, compared with $62,000 for the first quarter of 2019, with the increase mainly due to $2.1 million in warrant inducement expense. In January 2020, Biocept completed a Warrant Exercise Inducement offering for net proceeds of approximately $2.3 million.

The net loss attributable to common shareholders for the first quarter of 2020 was $8.3 million, or $0.11 per share on 79.0 million weighted-average shares outstanding and included $2.1 million in non-cash warrant inducement expense and the impact of the COVID-19 pandemic. The net loss attributable to common shareholders for the first quarter of 2019 was $6.0 million, or $0.61 per share on 9.8 million weighted-average shares outstanding.

Biocept reported cash and cash equivalents as of March 31, 2020 of $21.5 million, compared with $9.3 million as of December 31, 2019. The increase included approximately $17.7 million in net proceeds from two registered direct offerings and the overallotment of warrants from a December 2019 financing. In April 2020, the Company raised net proceeds of approximately $9.6 million from a registered direct offering.

Conference Call and Webcast

Biocept will hold a conference call today at 4:30 p.m. Eastern time to discuss these results and answer questions. The conference call can be accessed by dialing (855) 656-0927 for domestic callers, (855) 669-9657 for Canadian callers or (412) 902-4109 for other international callers. A live webcast of the conference call will be available on the investor relations page of the company’s website at http://ir.biocept.com/events.cfm.

A replay of the call will be available for 48 hours following its conclusion and can be accessed by dialing (877) 344-7529 for domestic callers, (855) 669-9658 for Canadian callers or (412) 317-0088 for other international callers. Please use event passcode 10143445. A replay of the webcast will be available for 90 days.

On May 13, 2020 Polynoma LLC, a U.S. immuno-oncology focused biopharmaceutical company and wholly-owned subsidiary of Hong Kong-listed CK Life Sciences Int’l., (Holdings) Inc., reported final analysis of clinical data from Part B1 of MAVIS (Melanoma Antigen Vaccine Immunotherapy Study), a Phase III study of seviprotimut-L, an investigational melanoma vaccine candidate, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program, to be held online May 29-31, 2020 (Press release, Polynoma, MAY 13, 2020, View Source [SID1234557952]). The study abstract is one of 12 abstracts selected for discussion in the Melanoma/Skin Cancers poster discussion session.

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MAVIS is a multicenter, double-blind, placebo-controlled adaptive Phase III trial to assess the safety and efficacy of seviprotimut-L, with primary endpoints of recurrence-free survival (RFS) and overall survival (OS) in patients with American Joint Committee on Cancer (AJCC) Stage IIB/C, IIIA, IIIB/C melanoma at high risk of recurrence after definitive surgical resection.

Highlights of the data presented include:

Improved outcomes in Stage IIB/C patients: Final analysis of subgroups confirmed the findings from the interim analysis, suggesting enhanced RFS for seviprotimut-L in patients with AJCC Stage IIB/IIC melanoma, particularly those under age 60, and those with ulceration, whose lesions are considered more serious because they have a greater risk of metastasis.1
Early evidence of survival benefit in Stage IIB/C patients: For Stage IIB/IIC melanoma patients under 60, there was a trend toward improved overall survival for those treated with seviprotimut-L.
Favorable adverse event profile: Seviprotimut-L was well-tolerated with treatment-emergent adverse events (AEs) similar to patients given placebo. There were no treatment-related serious adverse events.
Melanoma is the most diagnosed cancer among 25 to 29 year-olds in the United States, and passage from Stage II to Stage III melanoma marks a critical therapeutic intervention point to improve survival. Treatment of Stage IIB/IIC melanoma is primarily limited to surgery, coupled with a "wait and see" approach. However, recurrence of the disease can occur following definitive resection of the melanoma. Many patients progress to more advanced stages following resection and 5-year survival rates fall sharply after a patient passes from localized Stage II melanoma into regional Stage III disease (98.4% to 63.6%). Five-year survival rates are distinctly lower (22.5%) for metastatic Stage IV.2

"The final analysis of this part of the study reinforces the findings from our interim analysis last year, suggesting improved outcomes with seviprotimut-L in Stage IIB/IIC melanoma patients, particularly in those aged under 60. Furthermore, the latest findings extend the benefit to include disease with ulceration," said Melvin Toh, Chief Technology Officer at Polynoma and Vice President & Chief Scientific Officer at CK Life Sciences. "With a median patient follow-up of more than 48 months, the data show a durable RFS clinical benefit of seviprotimut-L in Stage IIB/IIC melanoma. We believe seviprotimut-L will be an important new option for the adjuvant treatment of patients with localized melanoma and look forward to advancing seviprotimut-L into the definitive part of the MAVIS Study."

"These data show promise for seviprotimut-L as a vaccine-based treatment of melanoma," said Craig L. Slingluff Jr., MD, Professor of Surgery and Director of the Human Immune Therapy Center and co-leader of the Cancer Therapeutics Program of the UVA Cancer Center. "These findings support moving forward with a pivotal trial testing seviprotimut-L as an adjuvant treatment for patients with Stage IIB/C melanoma, with stratification by age."

FURTHER DETAILS ON POSTER PRESENTATION AND DISCUSSION SESSION:

Abstract 10017: Final analysis of relapse-free survival in a multicenter, double-blind, placebo-controlled trial of seviprotimut-L polyvalent melanoma vaccine after resection of high-risk melanoma.

Poster: 366
Authors: Craig L. Slingluff, Jr., MD; Brent A. Blumenstein, PhD; Karl D. Lewis, MD; Robert H. Andtbacka, MD, CM, FACS, FRCSC; John Hyngstrom, MD; Mohammed Milhem, MBBS; Svetomir N. Markovic, MD, PhD; Omid Hamid, MD; Leonel Hernandez-Aya, MD PhD; Tawnya L. Bowles, MD; Prejesh Philips, MD; Sekwon Jang, MD; Jose Lutzky, MD, FACP; Anna Bar, MD; Peter D. Beitsch, MD
Poster Discussion Session

Session Title: Melanoma/Skin Cancers
Presentation Title: Adjuvant/Neoadjuvant Approaches
Discussant: Kenneth F. Grossmann, MD, PhD | Huntsman Cancer Institute, University of Utah
Poster and Discussion: will be available "on demand" on the ASCO (Free ASCO Whitepaper) website starting May 29 at 8:00 am EDT
The data being presented assessed the treatment effects of seviprotimut-L in patients with AJCCv7 Stage IIB-III cutaneous melanoma after surgical resection. 347 patients ages 18-75, ECOG PS 0-1, were enrolled and randomized 2:1 to seviprotimut-L 40 mcg or placebo, administered intradermally every 2 weeks x 5, then monthly x 4, then every 3 months to month 24. Patients were stratified by Stage (IIB/C, IIIA, IIIB/C).

By intent-to-treat (ITT) analysis, RFS was not significantly enhanced for seviprotimut-L in the full study population but trended toward benefit (Hazard Ratio "HR" = 0.88). Subgroup analysis based on planned stratification revealed the HR for the Stage IIB/IIC subset to be 0.65 (number of patients, "N" =111, 95% CI [0.37, 1.17]), favoring seviprotimut-L.

Age has been identified as a cause of decreased immune competence;3 thus, outcomes were assessed as a function of age as an effect modifier. Final efficacy analysis of subgroups confirmed treatment with seviprotimut-L enhanced RFS for patients less than 60 years overall (N=191, HR=0.64, 95% CI [0.38, 1.08]) and among Stage IIB/IIC melanoma patients (N=52, HR=0.32, 95% CI [0.12, 0.86]).

Furthermore, in a multivariable RFS model, for Stage IIB/IIC patients less than 60 years with ulceration, the HR was 0.209 (N=38, 95% CI [0.07,0.61]). For OS, for patients less than 60, HR = 0.41 [0.33,1.14] (n=191, 19 deaths) and for those ≥60, HR = 0.92 [0.39,2.12] (n = 156, 24 deaths).

In the study, seviprotimut-L was well-tolerated with treatment-emergent adverse events (AEs) similar to placebo patients. There were no treatment-related serious adverse events (SAEs) in the 347 patients studied, and the vast majority of events were Grade 1-2 injection site reactions that were managed by topical cream/s or an over-the-counter antihistamine.

About MAVIS
MAVIS (Melanoma Antigen Vaccine Immunotherapy Study) is a multicenter, double-blind, placebo-controlled adaptive Phase III trial to assess the safety and efficacy of seviprotimut-L, with primary endpoints of recurrence-free survival (RFS) and overall survival (OS) in patients with melanoma at high risk of recurrence after definitive surgical resection. MAVIS is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. For additional information about the trial, please visit View Source

About Seviprotimut-L
Seviprotimut-L is an allogeneic, polyvalent, partially purified shed melanoma antigen vaccine derived from three proprietary human melanoma cell lines. Seviprotimut-L stimulates humoral and cellular immune responses. Melanoma-associated antigens (MAAs) found in seviprotimut-L are taken up by antigen-presenting cells (e.g., dendritic cells) which then activate the production of antigen-specific cytotoxic T-lymphocytes (CTLs) as well as develop antibody responses against MAAs. These CTLs and antibodies then recognize and act on tumor cells expressing the MAAs on their surfaces, causing cell death. Seviprotimut-L is currently in development for the adjuvant treatment of patients with Stages IIB to IIIC melanoma, following definitive resection.

On May 13, 2020 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported the company will share updates from its diverse clinical oncology portfolio at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from May 29-31 taking place virtually (Press release, Regeneron, MAY 13, 2020, View Source [SID1234557951]).

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Among the accepted abstracts are new, longer-term data for PD-1 inhibitor Libtayo (cemiplimab-rwlc) in advanced cutaneous squamous cell carcinoma (CSCC). The data published today, which will be updated during ASCO (Free ASCO Whitepaper), add to the most mature dataset for any therapy in advanced CSCC and show that median overall survival and median duration of response have yet to be reached for Libtayo-treated patients with no new safety signals observed. Additional abstracts outline the clinical trial designs for Regeneron’s first costimulatory bispecific REGN5678 (PSMAxCD28) in metastatic castration-resistant prostate cancer and the company’s first tumor-targeted bispecific REGN5093 (METxMET) in MET-altered advanced non-small cell lung cancer (NSCLC).

"Regeneron is committed to advancing an oncology program to potentially transform treatment paradigms across multiple solid tumors and blood cancers where there are significant unmet needs," said Israel Lowy, M.D., Senior Vice President, Translational and Clinical Sciences, Oncology at Regeneron. "We’ve already made significant progress. Libtayo is the standard of care for advanced cutaneous squamous cell carcinoma, and we recently announced clinically meaningful outcomes from our pivotal Libtayo trials in advanced non-small cell lung cancer and advanced basal cell carcinoma. At ASCO (Free ASCO Whitepaper), we will build on these milestones with three-year data from Libtayo in advanced cutaneous squamous cell carcinoma and updates from our expanding bispecific antibody platform."

Investor Webcast Information
Regeneron will host a conference call and simultaneous webcast to share updates on Regeneron’s oncology portfolio on Monday, June 1 at 4:30 pm ET. To access this call, dial (888) 660-6127 (U.S.) or (973) 890-8355 (International). A link to the webcast may be accessed from the "Investors and Media" page of Regeneron’s website at www.regeneron.com. A replay of the conference call and webcast will be archived on the Company’s website and will be available for at least 30 days.

Regeneron presentations and publications at ASCO (Free ASCO Whitepaper)

Libtayo (PD-1 inhibitor) & Skin Cancer (jointly presented and published with Sanofi)

Phase 2 study of cemiplimab in patients (pts) with advanced cutaneous squamous cell carcinoma (CSCC): Longer follow-up (Abstract 10018, Poster 367; Danny Rischin, M.D.; Poster Discussion)
Health-related quality of life (HRQL) in patients with advanced cutaneous squamous cell carcinoma (CSCC) treated with cemiplimab: Post hoc exploratory analysis of a Phase 2 clinical trial (Abstract 10033, Poster 382; Michael Migden, M.D.; Poster)
Assessing the value of cemiplimab for adults with advanced cutaneous squamous cell carcinoma (CSCC): A cost-effectiveness analysis (Abstract e19397; Eleanor Paul; Online Publication)
A Phase 3, randomized, double-blind study of adjuvant cemiplimab versus placebo post-surgery and radiation therapy (RT) in patients (pts) with high-risk cutaneous squamous cell carcinoma (CSCC) (Abstract TPS10084, Poster 433; Danny Rischin, M.D.; Trial in Progress Poster)
Patterns of hedgehog inhibitor (HHI) treatment interruptions and re-initiations among patients with basal cell carcinoma (BCC) in real-world clinical practice (Abstract e19349; Jessica Jalbert, Ph.D.; Online Publication)
REGN5678 (PSMAxCD28 Costimulatory Bispecific)

A Phase 1/2 study of REGN5678 (Anti-PSMAxCD28, a costimulatory bispecific antibody) with cemiplimab (anti-PD-1) in patients with metastatic castration-resistant prostate cancer (Abstract TPS5592, Poster 173; Charles Drake, M.D., Ph.D.; Trial in Progress Poster)
REGN5093 (METxMET Tumor-targeted Bispecific)

A Phase 1/2 study of REGN5093, a METxMET bispecific antibody, in patients with MET-altered advanced non-small cell lung cancer (NSCLC) (Abstract TPS9628, Poster 394; Tracey Rowlands, Ph.D.; Trial in Progress Poster)
Diffuse Large B-Cell Lymphoma

Real-world treatment patterns among patients with diffuse large B-cell lymphoma (DLBCL) treated with CD19-directed chimeric antigen receptor T-cell therapy (CAR T) (Abstract e19351; Jessica Jalbert, Ph.D.; Online Publication)
About the Regeneron Bispecific Antibody Platform
All of Regeneron’s bispecifics are designed to closely resemble natural human antibodies and bind to two different targets. They are derived from a next-generation version of Regeneron’s proprietary VelocImmune technology and created using the company’s Veloci-Bi platform. These allow for the creation of bispecifics with no linkers or artificial sequences. Additionally, Regeneron bispecifics are manufactured using similar approaches used for human antibody medicines, with similar pharmacokinetics.

There are six Regeneron investigational bispecific antibodies currently in ongoing clinical trials for multiple blood cancers and solid tumors. These bispecifics fall into three categories:

CD3 bispecifics are designed to bridge T-cells and tumor cells. At the tumor site, they activate T-cells via their CD3 receptors and promote T-cell killing of the cancer cells. Investigational candidates include:
CD20xCD3 (odronextamab) for B-cell non-Hodgkin lymphoma;
Two distinct BCMAxCD3s (REGN5458 and REGN5459) for multiple myeloma;
MUC16xCD3 (REGN4018) for ovarian cancer.
CD28 costimulatory bispecifics are also designed to bridge T-cells and tumor cells. At the tumor site, they costimulate T-cells via their CD28 receptors and may synergize with PD-1 inhibitors and/or CD3 bispecifics. Investigational candidates include:
PSMAxCD28 (REGN5678) in combination with Libtayo for prostate cancer.
Tumor-targeted bispecifics are designed to target proteins only on the cancer cell. In this way, they may affect various signaling pathways to hamper the cancer cells’ ability to survive and proliferate. Investigational candidates include:
METxMET (REGN5093) for NSCLC that is driven by MET mutations and/or amplifications. REGN5093 targets two different parts of the MET receptor on cancer cells to degrade the receptor and block its ability to trigger cell proliferation.
The bispecifics mentioned in this release are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority. Libtayo in combination with REGN5678 is currently under clinical development for metastatic castration-resistant prostate cancer, and its safety and efficacy have not been evaluated by any regulatory authority for this use.

As part of a global collaboration agreement, Regeneron and Sanofi are jointly developing the BCMAxCD3 and MUC16xCD3 bispecific programs.

About Libtayo
Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation.

Libtayo is the first and only immunotherapy approved in the U.S., European Union, and other countries for adults with metastatic CSCC or locally advanced CSCC who are not candidates for curative surgery or curative radiation. In the U.S., the generic name for Libtayo in its approved indication is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration.

The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. In skin cancer, this includes a potentially registrational Phase 2 trial in basal cell carcinoma and additional trials in adjuvant and neoadjuvant CSCC. Libtayo is also being investigated in potentially registrational Phase 3 trials in NSCLC and cervical cancer, as well as in trials combining Libtayo with novel therapeutic approaches for both solid tumors and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.

Libtayo was invented using Regeneron’s proprietary VelocImmune technology that utilizes a proprietary genetically-engineered mouse platform endowed with a genetically-humanized immune system to produce optimized fully-human antibodies. VelocImmune technology has been used to create multiple antibodies including Dupixent (dupilumab), Praluent (alirocumab) and Kevzara (sarilumab), which are approved in multiple countries around the world. Regeneron previously used these technologies to rapidly develop a treatment for Ebola virus infection, which is currently under review by the FDA, and is now being used in efforts to create preventative and therapeutic medicines for COVID-19.

IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S. PATIENTS

What is Libtayo?
Libtayo is a prescription medicine used to treat people with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that has spread or cannot be cured by surgery or radiation.

It is not known if Libtayo is safe and effective in children.

What is the most important information I should know about Libtayo?
Libtayo is a medicine that may treat a type of skin cancer by working with your immune system. Libtayo can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended.

Call or see your healthcare provider right away if you develop any symptoms of the following problems or these symptoms get worse:

Lung problems (pneumonitis). Signs and symptoms of pneumonitis may include new or worsening cough, shortness of breath, and chest pain.
Intestinal problems (colitis) that can lead to tears or holes in your intestine. Signs and symptoms of colitis may include diarrhea (loose stools) or more frequent bowel movements than usual; stools that are black, tarry, sticky or that have blood or mucus; and severe stomach-area (abdomen) pain or tenderness.
Liver problems (hepatitis). Signs and symptoms of hepatitis may include yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), drowsiness, dark urine (tea colored), bleeding or bruising more easily than normal, and feeling less hungry than usual.
Hormone gland problems (especially the adrenal glands, pituitary, thyroid and pancreas). Signs and symptoms that your hormone glands are not working properly may include headaches that will not go away or unusual headaches, rapid heartbeat, increased sweating, extreme tiredness, weight gain or weight loss, dizziness or fainting, feeling more hungry or thirsty than usual, hair loss, feeling cold, constipation, deeper voice, very low blood pressure, urinating more often than usual, nausea or vomiting, stomach-area (abdomen) pain, and changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness.
Kidney problems, including nephritis and kidney failure. Signs of these problems may include decrease in your amount of urine, blood in your urine, swelling in your ankles, and loss of appetite.
Skin problems. Signs of these problems may include rash, itching, skin blistering, and painful sores or ulcers in the mouth, nose, throat, or genital area.
Problems in other organs. Signs of these problems may include headache, tiredness or weakness, sleepiness, changes in heartbeat (such as beating fast, seeming to skip a beat, or a pounding sensation), confusion, fever, muscle weakness, balance problems, nausea, vomiting, stiff neck, memory problems, seizures (encephalitis), swollen lymph nodes, rash or tender lumps on skin, cough, shortness of breath, vision changes, or eye pain (sarcoidosis), seeing or hearing things that are not there (hallucinations), severe muscle weakness, low red blood cells (anemia), bruises on the skin or bleeding, and changes in eyesight.
Rejection of a transplanted organ. Your doctor should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had.
Infusion (IV) reactions that can sometimes be severe and life-threatening. Signs of these problems may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, fever, feeling of passing out, back or neck pain, and facial swelling.
Getting medical treatment right away may help keep these problems from becoming more serious.

Your healthcare provider will check you for these problems during your treatment with Libtayo.
Your healthcare provider may treat you with corticosteroid or hormone replacement medicines.
Your healthcare provider may delay or completely stop treatment if you have severe side effects.

Before you receive Libtayo, tell your healthcare provider about all your medical conditions, including if you:

have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus;
have had an organ transplant;
have lung or breathing problems;
have liver or kidney problems;
have diabetes;
are pregnant or plan to become pregnant; Libtayo can harm your unborn baby.
Females who are able to become pregnant:
Your healthcare provider will give you a pregnancy test before you start treatment.
You should use an effective method of birth control during your treatment and for at least 4 months after your last dose of Libtayo. Talk with your healthcare provider about birth control methods that you can use during this time.
Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Libtayo.
are breastfeeding or plan to breastfeed. It is not known if Libtayo passes into your breast milk. Do not breastfeed during treatment and for at least 4 months after the last dose of Libtayo.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Libtayo include tiredness, rash, and diarrhea. These are not all the possible side effects of Libtayo. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Regeneron Pharmaceuticals and Sanofi at 1-877-542-8296.

On May 13, 2020 Amgen (NASDAQ:AMGN) reported that data from its oncology pipeline and marketed portfolio will be presented during the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program taking place May 29 – 31, 2020 (Press release, Amgen, MAY 13, 2020, View Source [SID1234557950]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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Notable data from the oncology pipeline include updated first-in-human studies evaluating sotorasib (AMG 510), a first-in-class investigational KRASG12C inhibitor, in patients with advanced colorectal cancer (CRC) and other solid tumors. Updated results from a Phase 1 dose escalation study of AMG 330, a BiTE (bispecific T cell engager) molecule, in acute myeloid leukemia will be featured in an oral presentation.

"The development of Amgen’s innovative medicines is rooted in our deep understanding of human and cancer genomes, which drives the advancement of next generation cancer treatments," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "At ASCO (Free ASCO Whitepaper), the data we are sharing reinforce our commitment to advancing first-in-class therapies that can alter the course of cancer care for patients who need it most."

Amgen’s abstracts are available on the ASCO (Free ASCO Whitepaper) website and include:

Clinical Data Abstracts (pipeline)

CodeBreak 100: Activity of AMG 510, a Novel Small Molecule Inhibitor of KRASG12C, in Patients With Advanced Colorectal Cancer
Abstract #4018, Poster Discussion

CodeBreak 100: Phase 1 Study of AMG 510, a Novel Small Molecule KRASG12C Inhibitor in Patients (pts) With Advanced Solid Tumors Other Than Non-Small Lung Cancer (NSCLC) or Colorectal Cancer (CRC)
Abstract #3511, Poster Discussion

Updated Results From Phase 1 Dose Escalation Study of AMG 330, a Bispecific T Cell Engager Molecule, in Patients With Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)
Abstract #7508, Oral Presentation

Characterization of Clinical Pharmacokinetics and Exposure-Response Relationships of AMG 330, a Bispecific CD33 T Cell Engager Antibody Construct, in Patients With Relapsed/Refractory AML
Abstract #7536, Poster

Efficacy and Safety of ABP 798 Compared with Rituximab: Results From the Comparative Clinical Study in Patients with Non-Hodgkin’s
Abstract #8044, Poster
KYPROLIS Clinical Data Abstract

Efficacy and Safety of Carfilzomib, Dexamethasone, Daratumumab (KdD) Twice-Weekly at 56 mg/m2 and Once-Weekly at 70 mg/m2 in Relapsed or Refractory Multiple Myeloma (RRMM): Cross-Study Comparison of CANDOR and MMY1001
Abstract #8526, Poster
IMLYGIC Clinical Data Abstracts

Early Safety From a Phase I, Multicenter, Open-Label Clinical Trial of Talimogene Laherparepvec (T-VEC) Injected (inj) Into Liver Tumors In Combination With Pembrolizumab (Pem)
Abstract #3015, Poster Discussion

Association Between Complete Response and Survival in Advanced Melanoma Treated with Talimogene Laherparepvec (T-VEC) Plus Ipilimumab (ipi)
Abstract #10029, Poster
Amgen Webcast Investor Meeting
Amgen will host a webcast call for the investment community in conjunction with the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program on Friday, May 29, at 1:00 p.m. PT. David M. Reese, M.D., executive vice president of Research and Development at Amgen, along with members of Amgen’s clinical development team and clinical investigators, will participate to discuss Amgen’s oncology program, including data being presented on the Company’s KRASG12C inhibitor sotorasib.

Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

To learn more about Amgen’s innovative pipeline with diverse modalities and genetically validated targets, please visit www.AmgenOncology.com.

About KRAS
The subject of almost four decades of research, the RAS gene family are the most frequently mutated oncogenes in human cancers.1,2 Within this family, KRAS is the most prevalent variant and is particularly common in solid tumors.2 A specific mutation known as KRAS G12C is found in approximately 13% of non-small cell lung cancers, three to five percent of colorectal cancers and one to two percent of numerous other solid tumors.3 KRASG12C has been considered "undruggable" due to a lack of traditional small molecule binding pockets on the protein. Amgen is exploring the potential of KRASG12C inhibition across a broad variety of tumor types.

About BiTE Technology
BiTE (bispecific T cell engager) technology is a targeted immuno-oncology platform that is designed to engage patient’s own T cells to any tumor-specific antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer. The BiTE immuno-oncology platform has the potential to treat different tumor types through tumor-specific antigens. The BiTE platform has a goal of leading to off-the-shelf solutions, which have the potential to make innovative T cell treatment available to all providers when their patients need it. Amgen is advancing more than a dozen BiTE molecules across a broad range of hematologic malignancies and solid tumors, further investigating BiTE technology with the goal of enhancing patient experience and therapeutic potential. To learn more about BiTE technology, visit www.AmgenBiTETechnology.com.

About KYPROLIS (carfilzomib)
Proteasomes play an important role in cell function and growth by breaking down proteins that are damaged or no longer needed.4 KYPROLIS has been shown to block proteasomes, leading to an excessive build-up of proteins within cells.5 In some cells, KYPROLIS can cause cell death, especially in myeloma cells because they are more likely to contain a higher amount of abnormal proteins.4,5

Since its first approval in 2012, approximately 150,000 patients worldwide have received KYPROLIS. KYPROLIS is approved in the U.S. for the following:

In combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy
As a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy
KYPROLIS is also approved in Algeria, Argentina, Australia, Bahrain, Belarus, Brazil, Canada, Chile, Colombia, Ecuador, Egypt, European Union, Hong Kong, India, Israel, Japan, Jordan, Kuwait, Lebanon, Macao, Malaysia, Mexico, Morocco, New Zealand, Oman, Peru, Philippines, Qatar, Russia, Saudi Arabia, Singapore, S. Korea, Switzerland, Taiwan, Thailand, Turkey and United Arab Emirates.

Important U.S. KYPROLIS (carfilzomib) Safety Information

Cardiac Toxicities

New onset or worsening of pre-existing cardiac failure (e.g., congestive heart failure, pulmonary edema, decreased ejection fraction), restrictive cardiomyopathy, myocardial ischemia, and myocardial infarction including fatalities have occurred following administration of KYPROLIS. Some events occurred in patients with normal baseline ventricular function. Death due to cardiac arrest has occurred within one day of administration.
Monitor patients for signs or symptoms of cardiac failure or ischemia. Evaluate promptly if cardiac toxicity is suspected. Withhold KYPROLIS for Grade 3 or 4 cardiac adverse events until recovery, and consider whether to restart at 1 dose level reduction based on a benefit/risk assessment.
While adequate hydration is required prior to each dose in Cycle 1, monitor all patients for evidence of volume overload, especially patients at risk for cardiac failure. Adjust total fluid intake as clinically appropriate.
For patients ≥ 75 years, the risk of cardiac failure is increased. Patients with New York Heart Association Class III and IV heart failure, recent myocardial infarction, conduction abnormalities, angina, or arrhythmias may be at greater risk for cardiac complications and should have a comprehensive medical assessment prior to starting treatment with KYPROLIS and remain under close follow-up with fluid management.
Acute Renal Failure

Cases of acute renal failure, including some fatal renal failure events, and renal insufficiency adverse events (including renal failure) have occurred. Acute renal failure was reported more frequently in patients with advanced relapsed and refractory multiple myeloma who received KYPROLIS monotherapy. Monitor renal function with regular measurement of the serum creatinine and/or estimated creatinine clearance. Reduce or withhold dose as appropriate.
Tumor Lysis Syndrome

Cases of Tumor Lysis Syndrome (TLS), including fatal outcomes, have occurred. Patients with a high tumor burden should be considered at greater risk for TLS. Adequate hydration is required prior to each dose in Cycle 1, and in subsequent cycles as needed. Consider uric acid lowering drugs in patients at risk for TLS. Monitor for evidence of TLS during treatment and manage promptly, and withhold until resolved.
Pulmonary Toxicity

Acute Respiratory Distress Syndrome (ARDS), acute respiratory failure, and acute diffuse infiltrative pulmonary disease such as pneumonitis and interstitial lung disease have occurred. Some events have been fatal. In the event of drug‐induced pulmonary toxicity, discontinue KYPROLIS.
Pulmonary Hypertension

Pulmonary arterial hypertension (PAH) was reported. Evaluate with cardiac imaging and/or other tests as indicated. Withhold KYPROLIS for PAH until resolved or returned to baseline and consider whether to restart based on a benefit/risk assessment.
Dyspnea

Dyspnea was reported in patients treated with KYPROLIS. Evaluate dyspnea to exclude cardiopulmonary conditions including cardiac failure and pulmonary syndromes. Stop KYPROLIS for Grade 3 or 4 dyspnea until resolved or returned to baseline. Consider whether to restart based on a benefit/risk assessment.
Hypertension

Hypertension, including hypertensive crisis and hypertensive emergency, has been observed, some fatal. Control hypertension prior to starting KYPROLIS. Monitor blood pressure regularly in all patients. If hypertension cannot be adequately controlled, withhold KYPROLIS and evaluate. Consider whether to restart based on a benefit/risk assessment.
Venous Thrombosis

Venous thromboembolic events (including deep venous thrombosis and pulmonary embolism) have been observed. Thromboprophylaxis is recommended for patients being treated with the combination of KYPROLIS with dexamethasone or with lenalidomide plus dexamethasone. The thromboprophylaxis regimen should be based on an assessment of the patient’s underlying risks.
Patients using hormonal contraception associated with a risk of thrombosis should consider an alternative method of effective contraception during treatment.
Infusion Reactions

Infusion reactions, including life‐threatening reactions, have occurred. Signs and symptoms include fever, chills, arthralgia, myalgia, facial flushing, facial edema, laryngeal edema, vomiting, weakness, shortness of breath, hypotension, syncope, chest tightness, or angina. These reactions can occur immediately following or up to 24 hours after administration. Pre-medicate with dexamethasone to reduce the incidence and severity of infusion reactions. Inform patients of the risk and of symptoms and seek immediate medical attention if they occur.
Hemorrhage

Fatal or serious cases of hemorrhage have been reported. Hemorrhagic events have included gastrointestinal, pulmonary, and intracranial hemorrhage and epistaxis. Promptly evaluate signs and symptoms of blood loss. Reduce or withhold dose as appropriate.
Thrombocytopenia

KYPROLIS causes thrombocytopenia with recovery to baseline platelet count usually by the start of the next cycle. Monitor platelet counts frequently during treatment. Reduce or withhold dose as appropriate.
Hepatic Toxicity and Hepatic Failure

Cases of hepatic failure, including fatal cases, have occurred. KYPROLIS can cause increased serum transaminases. Monitor liver enzymes regularly regardless of baseline values. Reduce or withhold dose as appropriate.
Thrombotic Microangiopathy

Cases of thrombotic microangiopathy, including thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), including fatal outcome have occurred. Monitor for signs and symptoms of TTP/HUS. Discontinue if diagnosis is suspected. If the diagnosis of TTP/HUS is excluded, KYPROLIS may be restarted. The safety of reinitiating KYPROLIS is not known.
Posterior Reversible Encephalopathy Syndrome (PRES)

Cases of PRES have occurred in patients receiving KYPROLIS. If PRES is suspected, discontinue and evaluate with appropriate imaging. The safety of reinitiating KYPROLIS is not known.
Increased Fatal and Serious Toxicities in Combination with Melphalan and Prednisone in Newly Diagnosed Transplant-ineligible Patients

In a clinical trial of transplant-ineligible patients with newly diagnosed multiple myeloma comparing KYPROLIS, melphalan, and prednisone (KMP) vs bortezomib, melphalan, and prednisone (VMP), a higher incidence of serious and fatal adverse events was observed in patients in the KMP arm. KMP is not indicated for transplant-ineligible patients with newly diagnosed multiple myeloma.
Embryo-fetal Toxicity

KYPROLIS can cause fetal harm when administered to a pregnant woman.
Females of reproductive potential should be advised to avoid becoming pregnant while being treated with KYPROLIS and for 6 months following the final dose. Males of reproductive potential should be advised to avoid fathering a child while being treated with KYPROLIS and for 3 months following the final dose. If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the patient should be apprised of the potential hazard to the fetus.
ADVERSE REACTIONS

The most common adverse reactions in the combination therapy trials: anemia, neutropenia, diarrhea, dyspnea, fatigue, thrombocytopenia, pyrexia, insomnia, muscle spasm, cough, upper respiratory tract infection, hypokalemia.
The most common adverse reactions in monotherapy trials: anemia, fatigue, thrombocytopenia, nausea, pyrexia, dyspnea, diarrhea, headache, cough, edema peripheral.
Please see full Prescribing Information at www.kyprolis.com.

About IMLYGIC (talimogene laherparepvec)
IMLYGIC is a genetically modified herpes simplex type 1 virus that is injected directly into tumors. IMLYGIC replicates inside tumor cells and produces GM-CSF, an immunostimulatory protein. IMLYGIC then causes the cell to rupture and die in a process called lysis. The rupture of the cancer cells causes the release of tumor-derived antigens, which together with virally derived GM-CSF may help to promote an anti-tumor immune response. The exact mechanism of action continues to be investigated.

IMLYGIC is the first and only oncolytic viral therapy approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regulatory authorities, based on therapeutic benefit demonstrated in a pivotal Phase 3 study. IMLYGIC is indicated for the local treatment of melanoma in patients with unresectable cutaneous, subcutaneous, or nodal lesions after initial surgery.

The IMLYGIC clinical program continues to investigate the role of IMLYGIC both as monotherapy and in combination with other therapies across a variety of cancers and treatment settings.

INDICATION & LIMITATIONS OF USE
IMLYGIC (talimogene laherparepvec) is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.

Limitations of use: IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases.

IMPORTANT SAFETY INFORMATION

Contraindications

Do not administer IMLYGIC to immunocompromised patients, including those with a history of primary or acquired immunodeficient states, leukemia, lymphoma, AIDS or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy, due to the risk of life-threatening disseminated herpetic infection.
Do not administer IMLYGIC to pregnant patients.
Warnings and Precautions

Accidental exposure to IMLYGIC may lead to transmission of IMLYGIC and herpetic infection, including during preparation and administration. Health care providers, close contacts, pregnant women, and newborns should avoid direct contact with injected lesions, dressings, or body fluids of treated patients. The affected area in exposed individuals should be cleaned thoroughly with soap and water and/or a disinfectant.
Caregivers should wear protective gloves when assisting patients in applying or changing occlusive dressings and observe safety precautions for disposal of used dressings, gloves, and cleaning materials. Exposed individuals should clean the affected area thoroughly with soap and water and/or a disinfectant.
To prevent possible inadvertent transfer of IMLYGIC to other areas of the body, patients should be advised to avoid touching or scratching injection sites or occlusive dressings.
Herpetic infections: Herpetic infections (including cold sores and herpetic keratitis) have been reported in IMLYGIC-treated patients. Disseminated herpetic infection may also occur in immunocompromised patients. Patients who develop suspicious herpes-like lesions should follow standard hygienic practices to prevent viral transmission.
Patients or close contacts with suspected signs or symptoms of a herpetic infection should contact their health care provider to evaluate the lesions. Suspected herpetic lesions should be reported to Amgen at 1-855-IMLYGIC (1-855-465-9442). Patients or close contacts have the option of follow-up testing for further characterization of the infection.
IMLYGIC is sensitive to acyclovir. Acyclovir or other antiviral agents may interfere with the effectiveness of IMLYGIC. Consider the risks and benefits of IMLYGIC treatment before administering antiviral agents to manage herpetic infection.
Injection Site Complications: Necrosis or ulceration of tumor tissue may occur during IMLYGIC treatment. Cellulitis and systemic bacterial infection have been reported in clinical studies. Careful wound care and infection precautions are recommended, particularly if tissue necrosis results in open wounds.
Impaired healing at the injection site has been reported. IMLYGIC may increase the risk of impaired healing in patients with underlying risk factors (e.g., previous radiation at the injection site or lesions in poorly vascularized areas). If there is persistent infection or delayed healing of the injection site, consider the risks and benefits of continuing treatment.
Immune-Mediated events including glomerulonephritis, vasculitis, pneumonitis, worsening psoriasis, and vitiligo have been reported in patients treated with IMLYGIC. Consider the risks and benefits of IMLYGIC before initiating treatment in patients who have underlying autoimmune disease or before continuing treatment in patients who develop immune-mediated events.
Plasmacytoma at the Injection Site: Plasmacytoma in proximity to the injection site has been reported in a patient with smoldering multiple myeloma after IMLYGIC administration in a clinical study. Consider the risks and benefits of IMLYGIC in patients with multiple myeloma or in whom plasmacytoma develops during treatment.
Obstructive Airway Disorder: Obstructive airway disorder has been reported following IMLYGIC treatment. Use caution when injecting lesions close to major airways.
Adverse Reactions

The most commonly reported adverse drug reactions (≥ 25%) in IMLYGIC-treated patients were fatigue, chills, pyrexia, nausea, influenza-like illness, and injection site pain. Pyrexia, chills, and influenza-like illness can occur at any time during IMLYGIC treatment, but were more frequent during the first 3 months of treatment.
The most common Grade 3 or higher adverse reaction was cellulitis.
Please see www.Imlygic.com for full Prescribing Information, including Medication Guide.

About Amgen Oncology
Amgen Oncology is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient’s life – not just their cancer journey – so they can take control of their lives.

For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company’s history, moving with great speed to advance those innovations for the patients who need them.

At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do.

For more information about Amgen Biosimilars, follow us on www.twitter.com/amgenoncology.

On May 13, 2020 Sanofi reported that it will present data from across its oncology franchise, including portfolio and pipeline compounds, during the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program from May 29-31 (Press release, Sanofi, MAY 13, 2020, View Source [SID1234557949]). Among the abstracts are new research highlighting the company’s leadership and commitment to the care of patients with non-melanoma skin cancer, prostate cancer, and multiple myeloma, and early stage clinical data for two potentially transformative therapies for breast and lung cancer.

Schedule your 30 min Free 1stOncology Demo!
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"We are determined to improve the outcomes for patients with cancer by developing transformative therapies, and this is a pivotal time to continue our commitment to patients and the oncology community," said Dietmar Berger, Global Head of Clinical Development and Chief Medical Officer. "We are fortunate to have recently welcomed Dr. Peter C. Adamson to lead our Global Oncology Development team, and he will continue to oversee our emerging pipeline. We are at the forefront of translating scientific advances into potential new treatments in our pipeline, and focused on addressing critical gaps that may help advance the care of several difficult-to-treat cancers."

Early-stage clinical results support innovative approaches in metastatic breast cancer and advanced non-small cell lung cancer

"Building upon advances in molecular- and immuno- oncology, our portfolio and pipeline strategy leverage leading-edge technology platforms to develop better therapies for patients with diverse malignancies including skin, blood, breast and lung cancers", said Peter C. Adamson, Global Development Head, Oncology and Pediatric Innovation. "We are leading the way with our investigational oral SERD that can serve as potential backbone treatment across multiple lines of therapy for patients with ER+ breast cancer, and our first-in-class investigational compound CEACAM5 antibody-drug conjugate for patients with lung cancer or potentially other CEACAM5-expressing solid tumors. We are excited to share early clinical and proof of concept data on both at the upcoming ASCO (Free ASCO Whitepaper)20 virtual meeting."

In the U.S., more than 154,000 women are estimated to have metastatic breast cancer (mBC)i and approximately 79% of breast cancers are estrogen receptor (ER) positive.ii SAR439859 is an investigational oral selective estrogen receptor degrader (SERD), a potential best-in-class small molecule targeted therapy that binds to ERs in breast cancer cells to inhibit ER signaling and trigger their degradation.

Abstract 1070: Phase 1/2 study of SAR439859, an oral selective estrogen receptor degrader (SERD), in estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC) (TED14856 – Part A and B data)
Abstract TPS1108: Phase 2 preoperative window study of SAR439859 versus letrozole in post-menopausal women with newly diagnosed estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer
Abstract TPS1107: Phase 2 trial of SAR439859 vs endocrine monotherapy in pre- and post-menopausal, estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2−), locally advanced or metastatic breast cancer (BC) with prior exposure to hormonal therapies
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer and accounts for 84% of all diagnoses.iii CEACAM5 is a cell-surface glycoprotein highly expressed in several tumor types, including NSCLC. Approximately 20% of lung cancers have a high expression of CEACAM5. Data will be presented on our first-in-class CEACAM5 antibody-drug conjugate during an oral presentation at ASCO (Free ASCO Whitepaper)20.

Abstract 9505: Efficacy and safety of the antibody-drug conjugate (ADC) SAR408701 in non-squamous non-small cell lung cancer (NSQ NSCLC) patients (pts) expressing carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) (Oral presentation)
Abstract TPS9625: Phase 3 trial comparing antibody-drug conjugate (ADC) SAR408701 with docetaxel in patients with metastatic non-squamous non-small cell lung cancer (NSQ NSCLC) failing chemotherapy and immunotherapy
Long-term data for Libtayo (cemiplimab-rwlc) in advanced CSCC

Cutaneous squamous cell carcinoma (CSCC) is one of the most commonly diagnosed skin cancers worldwide, and although the majority of patients have a good prognosis when the cancer is discovered early, it can be especially difficult to treat successfully when it progresses to advanced stages.iv-v-vi-vii-viii New longer-term data from the pivotal Phase 2 study of Libtayo offer updated efficacy and safety outcomes that add to the most mature dataset for any therapy in advanced CSCC. In the U.S., Libtayo is approved for the treatment of patients with metastatic CSCC or locally advanced CSCC who are not candidates for curative surgery or curative radiation. Libtayo is a PD-1 immune checkpoint inhibitor being jointly developed with Regeneron under a global collaboration agreement.

Abstract 10018: Phase 2 study of cemiplimab in patients with advanced cutaneous squamous cell carcinoma: longer follow-up
Abstract TPS10084: A Phase 3, randomized, double-blind study of adjuvant cemiplimab versus placebo post-surgery and radiation therapy (RT) in patients (pts) with high-risk cutaneous squamous cell carcinoma (CSCC)
Abstract 10033: Health-related quality of life in patients with advanced cutaneous squamous cell carcinoma treated with cemiplimab: post hoc exploratory analysis of a phase 2 clinical trial
On-line Publication: Patterns of hedgehog inhibitor treatment interruptions and re-initiations among patients with basal cell carcinoma in real-world clinical practice
On-line Publication: Assessing the value of cemiplimab for adults with advanced cutaneous squamous cell carcinoma: a cost-effectiveness analysis
Growing body of evidence in multiple myeloma and metastatic castration-resistant prostate cancer

Multiple myeloma (MM) is the second most common hematologic malignancy,ix and, despite available treatments, the disease is associated with significant patient burden. Results from a Phase 1b study evaluating Sarclisa (isatuximab-irfc) in newly diagnosed MM patients who are ineligible for transplant add to a growing body of positive data. Sarclisa, a monoclonal antibody that binds to the CD38 receptor on MM cells, is approved for use in the U.S. in combination with pomalidomide and dexamethasone for the treatment of adults who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

Abstract 8529: Updates from a Phase Ib study of isatuximab, bortezomib and dexamethasone plus cyclophosphamide or lenalidomide in transplant ineligible newly diagnosed multiple myeloma
Prostate cancer is a very heterogenous disease and one of the most common types of cancer in men.x Metastatic castration-resistant prostate cancer (mCRPC) is prostate cancer that has spread beyond the prostate gland and progressed despite androgen deprivation therapy.xi Results from a post-hoc analysis of the CARD clinical trial highlight that overall survival was significantly longer with Jevtana (cabazitaxel) versus abiraterone or enzalutamide in patients with mCRPC who had been previously treated with docetaxel and had disease progression within 12 months on a prior androgen receptor-targeted agent.

Abstract 5569: CARD: Overall survival (OS) analysis of patients with metastatic castration-resistant prostate cancer (mCRPC) receiving cabazitaxel vs abiraterone or enzalutamide
Abstract 5559: Efficacy and safety in older patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) receiving cabazitaxel (CBZ) vs abiraterone (ABI) or enzalutamide (ENZ) in the CARD study
Abstract 5558: Pain progression at initiation of cabazitaxel in metastatic Castration-Resistant Prostate Cancer (mCRPC) is associated with a poor prognosis: a post-hoc analysis of PROSELICA
Additional research at ASCO (Free ASCO Whitepaper)20 Virtual Meeting supported by Sanofi include:

Sarclisa (isatuximab-irfc)

Abstract 8508

Depth of Response to Isatuximab, Carfilzomib, Lenalidomide and Dexamethasone (Isa-KRd ) in Front-Line Treatment of High-Risk Multiple Myeloma: Interim Analysis of the GMMG-CONCEPT Trial

Mozobil (plerixafor)

On-line publication

Real World Stem Cell Mobilization (PBSC) Patterns in MM Pts Receiving Autologous Transplant (ASCT)

Eloxatin (oxaliplatin)

Abstract 3522

Longitudinal Cumulative Dose: A Novel Measure to Assess Multiple Dimensions of Chemotherapy Adherence Over Time

Abstract 7067

Effectiveness of adjuvant FOLFOX vs 5FU for colon cancer treatment in community oncology practice using a hybrid study approach

Taxotere (docetaxel)

Abstract 4551

Diagnostic accuracy of CT-staging of advanced gastric cancer following neoadjuvant chemotherapy.

Jevtana (cabazitaxel)

Abstract 11556

Activity of cabazitaxel in patients with metastatic or inoperable locally advanced dedifferentiated liposarcoma. European Organization for Research and Treatment of Cancer (EORTC) Phase 2 trial 1202

About Libtayo

Libtayo is approved in the U.S., EU, and other countries for adult patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. In the U.S., the generic name for Libtayo is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration.

The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. In skin cancer, this includes a potentially registrational Phase 2 trial in basal cell carcinoma, a Phase 3 trial in adjuvant setting in CSCC, and additional and neoadjuvant CSCC. . Libtayo is also being investigated in potentially registrational Phase 3 trials in non-small cell lung cancer and cervical cancer, as well as in trials combining Libtayo with novel therapeutic approaches for both solid tumors and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.

About Sarclisa

Sarclisa is a monoclonal antibody that binds to the CD38 receptor on multiple myeloma cells. CD38 is highly and uniformly expressed on multiple myeloma cells and cell surface receptors, making it a target for antibody-based therapeutics such as Sarclisa. It is designed to induce programmed tumor cell death (apoptosis) and immunomodulatory activity.

Sarclisa is approved in the U.S. in combination with pomalidomide and dexamethasone for the treatment of adults with relapsed refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. In the U.S., the generic name for Sarclisa is isatuximab-irfc, with irfc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration.

Sarclisa has also received a positive CHMP opinion in combination with pomalidomide and dexamethasone for the treatment of adults with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy. A final decision on the Marketing Authorisation Application for Sarclisa in the E.U. is expected in the coming months. The safety and efficacy of Sarclisa have not been fully evaluated by any regulatory authority outside of the U.S., Switzerland, Canada, and Australia.

Sarclisa continues to be evaluated in multiple ongoing Phase 3 clinical trials in combination with current standard treatments across the multiple myeloma treatment continuum. It is also under investigation for the treatment of other hematologic malignancies and solid tumors. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.

About Jevtana (cabazitaxel)

Jevtana is a semi-synthetic taxane chemotherapy. Jevtana is a microtubule inhibitor that binds to tubulin and promotes its assembly into microtubules while simultaneously inhibiting disassembly. This leads to the stabilization of microtubules, which results in the inhibition of mitotic and interphase cellular functions.

Jevtana is indicated, in combination with prednisone, for the treatment of adult men with mCRPC previously treated with a docetaxel-containing treatment regimen.

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR U.S. PATIENTS

What is Libtayo?

Libtayo is a prescription medicine used to treat people with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that has spread or cannot be cured by surgery or radiation.

It is not known if Libtayo is safe and effective in children.

What is the most important information I should know about Libtayo?

Libtayo is a medicine that may treat a type of skin cancer by working with your immune system. Libtayo can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended.

Call or see your healthcare provider right away if you develop any symptoms of the following problems or these symptoms get worse:

Lung problems (pneumonitis). Signs and symptoms of pneumonitis may include new or worsening cough, shortness of breath, and chest pain.
Intestinal problems (colitis) that can lead to tears or holes in your intestine. Signs and symptoms of colitis may include diarrhea (loose stools) or more frequent bowel movements than usual; stools that are black, tarry, sticky or that have blood or mucus; and severe stomach-area (abdomen) pain or tenderness.
Liver problems (hepatitis). Signs and symptoms of hepatitis may include yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), drowsiness, dark urine (tea colored), bleeding or bruising more easily than normal, and feeling less hungry than usual.
Hormone gland problems (especially the adrenal glands, pituitary, thyroid and pancreas). Signs and symptoms that your hormone glands are not working properly may include headaches that will not go away or unusual headaches, rapid heartbeat, increased sweating, extreme tiredness, weight gain or weight loss, dizziness or fainting, feeling more hungry or thirsty than usual, hair loss, feeling cold, constipation, deeper voice, very low blood pressure, urinating more often than usual, nausea or vomiting, stomach-area (abdomen) pain, and changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness.
Kidney problems, including nephritis and kidney failure. Signs of these problems may include decrease in your amount of urine, blood in your urine, swelling in your ankles, and loss of appetite.
Skin problems. Signs of these problems may include rash, itching, skin blistering, and painful sores or ulcers in the mouth, nose, throat, or genital area.
Problems in other organs. Signs of these problems may include headache, tiredness or weakness, sleepiness, changes in heartbeat (such as beating fast, seeming to skip a beat, or a pounding sensation), confusion, fever, muscle weakness, balance problems, nausea, vomiting, stiff neck, memory problems, seizures (encephalitis), swollen lymph nodes, rash or tender lumps on skin, cough, shortness of breath, vision changes, or eye pain (sarcoidosis), seeing or hearing things that are not there (hallucinations), severe muscle weakness, low red blood cells (anemia), bruises on the skin or bleeding, and changes in eyesight.
Rejection of a transplanted organ. Your doctor should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had.
Infusion (IV) reactions that can sometimes be severe and life-threatening. Signs of these problems may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, fever, feeling of passing out, back or neck pain, and facial swelling.
Getting medical treatment right away may help keep these problems from becoming more serious.

Your healthcare provider will check you for these problems during your treatment with Libtayo. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may delay or completely stop treatment if you have severe side effects.

Before you receive Libtayo, tell your healthcare provider about all your medical conditions, including if you:

have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus;
have had an organ transplant;
have lung or breathing problems;
have liver or kidney problems;
have diabetes;
are pregnant or plan to become pregnant; Libtayo can harm your unborn baby.
Females who are able to become pregnant:

Your healthcare provider will give you a pregnancy test before you start treatment.
You should use an effective method of birth control during your treatment and for at least 4 months after your last dose of Libtayo. Talk with your healthcare provider about birth control methods that you can use during this time.
Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Libtayo.
are breastfeeding or plan to breastfeed. It is not known if Libtayo passes into your breast milk. Do not breastfeed during treatment and for at least 4 months after the last dose of Libtayo.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Libtayo include tiredness, rash, and diarrhea. These are not all the possible side effects of Libtayo. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Regeneron Pharmaceuticals and Sanofi at 1-877-542-8296.

For more information, please see full Prescribing Information, including Medication Guide.

What is SARCLISA?

SARCLISA is a prescription medicine used in combination with pomalidomide and dexamethasone to treat adults who have received at least 2 prior therapies, including lenalidomide and a proteasome inhibitor, to treat multiple myeloma.

It is not known if SARCLISA is safe and effective in children.

Do not receive SARCLISA if you have a history of severe allergic reaction to isatuximab-irfc or any of the ingredients in SARCLISA (see the list of ingredients in full Prescribing Information).

Before receiving SARCLISA, tell your healthcare provider about all of your medical conditions, including if you:

are pregnant or plan to become pregnant. SARCLISA may harm your unborn baby. You should not receive SARCLISA during pregnancy.
Females who are able to become pregnant should use an effective method of birth control during treatment and for 5 months after your last dose of SARCLISA. Talk to your healthcare provider about birth control methods that you can use during this time.
Tell your healthcare provider right away if you think you are pregnant or become pregnant during treatment with SARCLISA.

are breastfeeding or plan to breastfeed. It is not known if SARCLISA passes into your breast milk. You should not breastfeed during treatment with SARCLISA.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive SARCLISA?

SARCLISA will be given to you by your healthcare provider by intravenous (IV) infusion into your vein.
SARCLISA is given in treatment cycles of 28 days (4 weeks), together with the medicines pomalidomide and dexamethasone.
In cycle 1, SARCLISA is usually given weekly.
Starting in cycle 2, SARCLISA is usually given every 2 weeks.
Your healthcare provider will decide how long you should receive SARCLISA.

If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.
Your healthcare provider will give you medicines before each dose of SARCLISA to help reduce the risk of infusion reactions (make them less frequent and severe).
What are the possible side effects of SARCLISA?

SARCLISA may cause serious side effects, including:

Infusion reactions. Infusion reactions are common with SARCLISA and can sometimes be severe.
Your healthcare provider will prescribe medicines before each infusion of SARCLISA to help decrease your risk for infusion reactions or to help make any infusion reaction less severe. You will be monitored for infusion reactions during each dose of SARCLISA.
Your healthcare provider may slow down or stop your infusion, or completely stop treatment with SARCLISA, if you have an infusion reaction.
Tell your healthcare provider right away if you develop any of the following symptoms of infusion reaction during or within 24 hours after an infusion of SARCLISA:

feeling short of breath
cough
chills
nausea
Decreased white blood cell counts. Decreased white blood cell counts are common with SARCLISA and certain white blood cells can be severely decreased. You may have an increased risk of getting certain infections, such as upper and lower respiratory infections.
Your healthcare provider will check your blood cell counts during treatment with SARCLISA. Your healthcare provider may prescribe an antibiotic or antiviral medicine to help prevent infection, or a medicine to help increase your white blood cell counts during treatment with SARCLISA.

Tell your healthcare provider right away if you develop any fever or symptoms of infection during treatment with SARCLISA.

Risk of new cancers. New cancers have happened in people during treatment with SARCLISA. Your healthcare provider will monitor you for new cancers during treatment with SARCLISA.
Change in blood tests. SARCLISA can affect the results of blood tests to match your blood type. Your healthcare provider will do blood tests to match your blood type before you start treatment with SARCLISA. Tell all of your healthcare providers that you are being treated with SARCLISA before receiving blood transfusions.
The most common side effects of SARCLISA include:

– lung infection (pneumonia)

– upper respiratory tract infection

– diarrhea

– decreased red blood cell counts (anemia)

– decreased platelet counts (thrombocytopenia)

These are not all the possible side effects of SARCLISA. For more information, ask your healthcare provider or pharmacist.

Please see full Prescribing Information, including Patient Information.

What is JEVTANA?

JEVTANA is a prescription medicine used with the steroid medicine prednisone. JEVTANA is used to treat men with castration-resistant prostate cancer (prostate cancer that is resistant to medical or surgical treatments that lower testosterone) that has spread to other parts of the body, and that has worsened (progressed) after treatment with other medicines that included docetaxel.

It is not known if JEVTANA is safe and effective in children.

What is the most important information I should know about JEVTANA?

JEVTANA may cause serious side effects, including:

Low white blood cells, which can cause you to get serious infections, and may lead to death. Men who are 65 years or older may be more likely to have these problems. Your healthcare provider (HCP):
will do blood tests regularly to check your white blood cell counts during your treatment with JEVTANA.
may lower your dose of JEVTANA, change how often you receive it, or stop JEVTANA until your HCP decides that you have enough white blood cells.
may prescribe a medicine for you called G-CSF, to help prevent complications if your white blood cell count is too low.
Tell your HCP right away if you have any of these symptoms of infection during treatment with JEVTANA: fever (take your temperature often during treatment with JEVTANA), cough, burning during urination, or muscle aches.

Also, tell your HCP if you have any diarrhea during the time that your white blood cell count is low. Your HCP may prescribe treatment for you as needed.

Severe allergic reactions can happen within a few minutes after your infusion of JEVTANA starts, especially during the first and second infusions. Your HCP should prescribe medicines before each infusion to help prevent severe allergic reactions.
Tell your HCP right away if you have any of these symptoms of a severe allergic reaction during or soon after an infusion of JEVTANA: rash or itching, skin redness, feeling dizzy or faint, breathing problems, chest or throat tightness, or swelling of face.

Severe stomach and intestine (gastrointestinal) problems.
JEVTANA can cause severe vomiting and diarrhea, which may lead to death. Severe vomiting and diarrhea with JEVTANA can lead to loss of too much body fluid (dehydration), or too much of your body salts (electrolytes). Death has happened from having severe diarrhea and losing too much body fluid or body salts with JEVTANA. You may need to go to the hospital for treatment. Your HCP will prescribe medicines to prevent or treat vomiting and diarrhea, as needed with JEVTANA.
Tell your HCP if you have vomiting or diarrhea, or if your symptoms get worse or do not get better.
JEVTANA can cause a leak in the stomach or intestine, intestinal blockage, infection, and bleeding in the stomach or intestine, which may lead to death.
Tell your HCP if you get any of these symptoms: severe stomach-area (abdomen) pain, constipation, fever, blood in your stool, or changes in the color of your stool
Kidney failure may happen with JEVTANA, because of severe infection, loss of too much body fluid (dehydration), and other reasons, which may lead to death. Your HCP will check you for this problem and treat you if needed.
Tell your HCP if you develop these signs or symptoms: swelling of your face or body, decrease in the amount of urine that your body makes each day or blood in your urine.
Inflammation of the bladder and blood in the urine. Blood in the urine is common with JEVTANA, but it can also sometimes be severe. Some people who have had pelvic radiation in the past may develop inflammation of the bladder and blood in the urine that is severe enough that they may need to be hospitalized for medical treatment or surgery. Your healthcare provider will check you for these problems during treatment with JEVTANA. Your healthcare provider may stop your treatment with JEVTANA for a short time, or permanently, if you develop inflammation of the bladder and bleeding that is severe.
Lung or breathing problems may happen with JEVTANA and may lead to death. Men who have lung disease before receiving JEVTANA may have a higher risk for developing lung or breathing problems with JEVTANA treatment. Your HCP will check you for this problem and treat you if needed. Tell your HCP right away if you develop any new or worsening symptoms, including trouble breathing, shortness of breath, chest pain, cough or fever.
Who should not receive JEVTANA?

Do not receive JEVTANA if: your white blood cell (neutrophil count) is too low, you have had a severe allergic reaction to cabazitaxel or other medicines that contain polysorbate 80 (ask your HCP if you are not sure), you have severe liver problems..

What should I tell my HCP before receiving JEVTANA?

Before receiving JEVTANA, tell your HCP if you:

are age 65 or older
had allergic reactions in the past
have kidney or liver problems
have lung problems
are pregnant or plant to become pregnant. JEVTANA can cause harm to your unborn baby and loss of pregnancy (miscarriage).
are a male with a female partner who is able to become pregnant. Males should use effective birth control (contraception) during treatment with JEVTANA and for 3 months after the last dose of JEVTANA.
JEVTANA may cause fertility problems in males. This may affect your ability to father a child. Talk to your HCP if you have concerns about fertility.

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. JEVTANA can interact with many other medicines. Do not take any new medicines without asking your HCP first. Your HCP will tell you if it is safe to take the new medicine with JEVTANA.

What are the most common side effects of JEVTANA?

The most common side effects of JEVTANA include:

– low red blood cell count (anemia), which is common with JEVTANA, but can sometimes also be serious. Your HCP will regularly check your red blood cell count. Symptoms of anemia include shortness of breath and tiredness.
unt, which is common with JEVTANA, but can sometimes also be serious. Tell your HCP if you have any unusual bruising or bleeding.

– fever

– Back pain

– diarrhea

– Change in your sense of appetite

– tiredness

– decreased appetite

– nausea

– shortness of breath

– vomiting

– cough

– constipation

– hair loss

– weakness

– numbness, tingling, burning or decreased sensation
in your hands or feet

– Stomach (abdominal) pain

Tell your HCP if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of JEVTANA. For more information, ask your HCP or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.