On May 15, 2019 Nektar Therapeutics (Nasdaq: NKTR) reported five abstracts accepted for presentation at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), which is being held from May 31 to June 4, 2019 at the McCormick Place Convention Center in Chicago, Illinois (Press release, Nektar Therapeutics, MAY 15, 2019, View Source [SID1234536369]). The abstracts published in advance of the ASCO (Free ASCO Whitepaper) Annual Meeting were made available at 5:00 p.m. Eastern Daylight Time today on the ASCO (Free ASCO Whitepaper) meeting website at View Source

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"We are pleased to announce the presentation of five abstracts for our lead I-O investigational candidate, bempegaldesleukin, which includes important translational clinical data for the combination of bempeg with nivolumab as well as early data from an investigator-sponsored pilot study conducted in patients with heavily pre-treated, rapidly progressing and refractory sarcomas," said Stephen Doberstein, Ph.D., Chief Research & Development Officer at Nektar. "We are also highlighting several registrational trials underway for bempeg plus nivo in patients with melanoma and RCC. We believe bempeg has a unique and non-overlapping mechanism which synergizes with various immunotherapies, including checkpoint inhibitors, to improve the body’s cancer-fighting immune response and potentially improve treatment outcomes for patients with a variety of cancers."

Details of abstract presentations are as follows:

Developmental Immunotherapy and Tumor Immunobiology
Abstract #2584/Poster Board #228*
Title: "Overcoming genetically-based resistance mechanisms to PD-1 blockade", Torrejon, D., et al.
Date: Saturday, June 1, 2019, 8:00 a.m. – 11:00 a.m. Central Time
Location: McCormick Place, Exhibit Hall A
*2019 ASCO (Free ASCO Whitepaper) Annual Meeting Merit Award recipient

Abstract #2623/Poster Board #267
Title: "Baseline tumor-immune signatures associated with response to bempegaldesleukin (NKTR-214) and nivolumab", Hurwitz, M., et al.
Date: Saturday, June 1, 2019, 8:00 a.m. – 11:00 a.m. Central Time
Location: McCormick Place, Exhibit Hall A

Emerging Combinations in Sarcoma Immunotherapy
Abstract #11010
Title: "Pilot study of bempegaldesleukin (NKTR-214) and nivolumab in patients with sarcomas"
Presenter: Sandra D’Angelo, M.D., Memorial Sloan Kettering Cancer Center
Date: Monday, June 3, 2019, 11:30 a.m. – 1:00 p.m. Central Time
Location: McCormick Place, S100a

Details of Trials in Progress poster presentations are as follows:

Melanoma/Skin Cancers
Abstract TPS9601/Poster Board #168b (Trials in progress (TiP) abstract)
Title: "CA045-001: A phase III, randomized, open label study of bempegaldesleukin (NKTR-214) plus nivolumab (NIVO) versus NIVO monotherapy in patients (pts) with previously untreated, unresectable or metastatic melanoma (MEL)", Khushalani, N., et al.
Date: Monday, June 3, 2019, 1:15 p.m. – 4:15 p.m. Central Time
Location: McCormick Place, Exhibit Hall A

Genitourinary (Nonprostate) Cancer
Abstract TPS4595/Poster Board #416b (Trials in progress (TiP) abstract)
Title: "A phase III randomized open label study comparing bempegaldesleukin (NKTR-214) plus nivolumab to sunitinib or cabozantinib (investigator’s choice) in patients with previously untreated advanced renal cell carcinoma", Tannir, N., et al.
Date: Monday, June 3, 2019, 1:15 p.m. – 4:15 p.m. Central Time
Location: McCormick Place, Exhibit Hall A

About Bempegaldesleukin (NKTR-214)
Bempegaldesleukin is an investigational, first-in-class, CD122-preferential IL-2 pathway agonist designed to provide rapid activation and proliferation of cancer-killing immune cells, known as CD8+ effector T cells and natural killer (NK) cells, without over activating the immune system. Bempegaldesleukin stimulates these cancer-killing immune cells in the body by targeting CD122 specific receptors found on the surface of these immune cells. CD122, which is also known as the Interleukin-2 receptor beta subunit, is a key signaling receptor that is known to increase proliferation of these effector T cells.1 In clinical and preclinical studies, treatment with bempegaldesleukin resulted in expansion of these cells and mobilization into the tumor micro-environment.2,3 Bempegaldesleukin has an antibody-like dosing regimen similar to the existing checkpoint inhibitor class of approved medicines.

On May 15, 2019 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. pharmaceutical company with a platform to develop and accelerate the launch of innovative therapeutics and pharmaceutical products in China, the U.S., and throughout the world, reported financial results for the first quarter 2019 and provided a review of recent accomplishments and anticipated upcoming milestones (Press release, CASI Pharmaceuticals, MAY 15, 2019, View Source [SID1234536320]).

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Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, "We have made good progress in the first quarter of 2019. Most recently, we announced that we acquired exclusive worldwide rights to a novel anti-CD38 monoclonal antibody (CID-103). Preclinical data suggests an enhanced safety and efficacy profile against a broad array of hematological malignancies expressing CD38, making CID-103 an excellent strategic fit amid our broader oncology platform. We look forward to announcing progress in this program as well as across other key programs in our pipeline."

First Quarter and Recent Business Highlights

Acquired worldwide rights to CID-103, a novel anti-CD38 monoclonal antibody – On April 17, 2019, CASI acquired worldwide rights to CID-103, a novel anti-CD38 monoclonal antibody. CID-103 is a human monoclonal antibody targeting a specific epitope of the CD38 cell surface antigen. It is at the IND/IMPD submission stage of development with Phase 1 trials expected in late 2019 or early 2020. The addition of CID-103 compliments the Company’s oncology pipeline and allows the Company to provide more treatment options to patients in the future.

Entered into distribution agreement with China distribution partner for EVOMELA (melphalan hydrochloride for injection) – In March 2019, the Company entered into an exclusive distribution agreement with China Resources Guokang Pharmaceuticals Co., Ltd., (CRGK) to be the Company’s exclusive distributor in China for EVOMELA. CASI will maintain responsibility for direct marketing and sales.

Received National Medical Products Administration (NMPA) Clinical Trial Application (CTA) Approvals – In February and March 2019, CASI announced key NMPA clinical trial approvals (CTA) to conduct confirmatory registration trials for both ZEVALIN and MARQIBO, respectively. ZEVALIN is indicated for relapsed or refractory, low-grade or follicular B-cell non-Hodgkin’s lymphoma and MARQIBO is indicated for Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies. The Company is working toward getting the trials started in China.

Chairman Wei-Wu He, Ph.D. expanded role to include Chief Executive Officer – On April 2, 2019, CASI appointed its Chairman of the Board of Directors as the Company’s Chief Executive Officer. Dr. He served on CASI’s Board of Directors since 2012. Dr. He has a very successful career building companies from early stage to revenue and profitability stages and most recently was the CEO of OriGene Technologies which he co-founded and built into a profitable life science company; OriGene ultimately merged with a publicly traded Chinese company in 2018.

Financial Results for the Quarter ended March 31, 2019

Cash Position: As of March 31, 2019, CASI had cash and cash equivalents of $99.7 million.

R&D Expenses: R&D expenses for the quarter ended March 31, 2019 were $2.6 million compared to $1.7 million in 2018, an increase of $0.9 million. The increase in R&D expenses primarily reflects costs associated with regulatory, consulting and manufacturing related services, primarily associated with our acquired ANDAs in 2018, as well as an increase in facility costs due to new lease space in China, as well as an increase in personnel costs due to growth in the number of employees.

G&A Expenses: G&A expenses for the quarter ended March 31, 2019 were $5.7 million compared to $1.3 million in 2018. The increase of $4.4 million in G&A over the prior year primarily reflects an increase of $1.6 million in non-cash stock compensation expense largely attributed to stock options issued to the Company’s Chairman and also the President of CASI China, an increase in salary, benefits and recruitment expense, as well as facilities costs primarily in China, related to sales and marketing efforts to prepare for the anticipated launch of the Company’s first commercial product in China, as well as other G&A functions. There were also increased costs associated with professional services fees, including audit and legal services during the 2019 period.

Net Loss: The Company reported a net loss of ($8.2 million), or ($0.09) per share, for the quarter ended March 31, 2019. This compares with a net loss of ($3.6 million), or ($0.05) per share for the first quarter of 2018. The larger net loss for both periods is primarily due to the increase in non-cash stock-based compensation expense during the 2019 period, costs associated with the manufacturing and regulatory support for our ANDA portfolio, and increased costs associated with G&A functions, including employment costs for sales and marketing efforts, as well as increased facilities cost in China and higher professional service fees.

Further information regarding the Company, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2019, can be found at www.casipharmaceuticals.com.

On May 15, 2019 Leap Therapeutics, Inc. (NASDAQ:LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, reported financial results for the first quarter ended March 31, 2019 (Press release, Leap Therapeutics, MAY 15, 2019, View Source [SID1234536337]).

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"In the first quarter, we presented important new data for both of our programs. DKN-01’s activity continues to be impressive in biomarker targeted patient populations, with single agent partial responses in patients with endometrial cancer. In addition, TRX518 achieved a first partial response as a monotherapy and as a combination therapy with gemcitabine," commented Christopher K. Mirabelli, Ph.D, President and Chief Executive Officer of Leap Therapeutics. "We are looking forward to presenting additional clinical data from both programs in the second half of the year."

Recent Developments

·DKN-01 in ESOPHAGOGASTRIC CANCER: Leap presented clinical data from its study evaluating DKN-01 in combination with KEYTRUDA (pembrolizumab) in patients with advanced esophagogastric cancer. The overall response rate and disease control rate has been higher in patients with higher DKK1 expression as measured by in situ hybridization RNAscope. Enrollment in this study is complete.

·DKN-01 in GYNECOLOGICAL CANCERS: At the Society for Gynecologic Oncology 50th Annual Meeting on Women’s Cancer, Leap presented an update on its clinical study evaluating DKN-01 as a monotherapy and in combination with paclitaxel in patients with advanced gynecological cancers. DKN-01 monotherapy has generated two partial responses in patients with endometrial cancer, and DKN-01 plus paclitaxel has generated a partial response in a patient with carcinosarcoma. An additional DKN-01 monotherapy patient was initially reported by the treating investigator to have experienced a partial response; however, further follow-up identified that the patient has a tumor reduction that does not meet the threshold for a partial response and remains on treatment with ongoing clinical benefit. Eighty-seven patients have been enrolled in the study, and enrollment is ongoing.

·DKN-01 in PROSTATE CANCER: The first patient has been enrolled in an investigator-initiated study of DKN-01 as a monotherapy and in combination with docetaxel in DKK1-positive metastatic prostate cancer patients.

·TRX518 MONOTHERAPY: A non-virally mediated hepatocellular cancer patient, who has been treated with single agent TRX518 for two years, achieved a partial response. With recent disease progression, this patient now continues on treatment for clinical benefit.

· TRX518 COMBINATION THERAPY: Leap presented data from its clinical trial evaluating TRX518 in combination with gemcitabine chemotherapy or in combination with KEYTRUDA or OPDIVO (nivolumab), with patients from each combination arm experiencing responses and durable stable disease. Eighteen patients have been enrolled in the TRX518/KEYTRUDA expansion cohort, and enrollment is ongoing.
Selected First Quarter 2019 Financial Results

Net loss was $8.6 million for the first quarter 2019, compared to $10.6 million for the same period in 2018. This decrease was primarily due to a non-cash charge based on the change in the fair value of the warrant liability in the first quarter 2018, offset by an increase in clinical development expense.

Research and development expenses were $6.8 million for the first quarter 2019, compared to $4.2 million for the same period in 2018. This increase was primarily due to an increase in clinical trial expenses associated with an increase in patient enrollment and an increase in consulting fees and payroll expenses, partially offset by a decrease in manufacturing costs related to clinical trial material.

General and administrative expenses were $2.0 million for the first quarter 2019, compared to $2.1 million for the same period in 2018. This decrease was primarily due to a decrease in compensation expense as a result of senior management not accepting the cash bonus awarded to them by the compensation committee, partially offset by an increase in stock-based compensation expense.

Cash, cash equivalents and marketable securities totaled $21.7 million at March 31, 2019. Research and development incentive receivables, current and long term, totaled approximately $0.9 million at March 31, 2019.

On May 15, 2019 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported mature data from the FORWARD II expansion cohort evaluating mirvetuximab soravtansine in combination with Avastin (bevacizumab) in patients with folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer (Press release, ImmunoGen, MAY 15, 2019, View Source [SID1234536354]). These findings will be presented at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is being held May 31 – June 4 in Chicago, IL.

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"We are pleased that the combination of mirvetuximab plus Avastin has generated significant anti-tumor activity in patients with platinum-resistant disease, with trends toward deeper, more durable responses seen in individuals with higher FRα expression and a favorable tolerability profile. The outcomes observed in patients with medium or high FRα expression are encouraging with respect to those reported in similar patient populations for Avastin plus chemotherapy," said Anna Berkenblit, M.D., Vice President and Chief Medical Officer of ImmunoGen. "Our goal remains to establish mirvetuximab as the combination agent of choice in ovarian cancer, supporting its use in earlier lines of therapy. These mature data support further exploration of this doublet, as well as the ongoing expansion study evaluating a triplet combination of mirvetuximab with Avastin and carboplatin in patients with platinum-sensitive disease."

DATA FROM FORWARD II EXPANSION COHORT WITH AVASTIN

Mirvetuximab soravtansine in combination with Avastin in patients with FRα-positive platinum-resistant ovarian cancer continues to demonstrate anti-tumor activity with durable responses and a favorable tolerability profile, particularly among the subset of patients who have received up to two prior lines of therapy and have medium or high levels of FRα expression.

Key findings in 66 patients with platinum-resistant disease include:

In the subset of 16 Avastin-naïve patients with medium or high FRα expression who have received up to two prior lines of therapy, the confirmed overall response rate (ORR) was 56 percent (95% CI 30,80), with a median progression-free survival (PFS) of 9.9 months (95% CI 4.1,15.9) and a median duration of response (DOR) of 12 months (95% CI 6,14.9).
In the overall patient population, the confirmed ORR was 39 percent (95% CI 28,52), with a median PFS of 6.9 months (95% CI 4.9,8.6) and a median DOR of 8.6 months (95% CI 4.9, 14.9).
The combination continues to display a safety profile in-line with the known profiles of each agent, with no new safety signals identified.
"Current treatment options for patients with platinum-resistant ovarian cancer have, unfortunately, exhibited limited efficacy with challenging side effects," stated David O’Malley, M.D., Professor, Director of Gynecology Clinical Trials and Phase 1 Program, James Cancer Center and The Ohio State University Wexner Medical Center, and FORWARD II Principal Investigator. "Final results from the combination of mirvetuximab soravtansine and Avastin expansion cohort demonstrate very encouraging activity and good tolerability in platinum-resistant ovarian cancer patients, especially those with medium or high FRα expression levels. I look forward to further evaluating mirvetuximab in combination with Avastin as well as in the triplet with carboplatin."

ASCO PRESENTATION DETAILS

Title: "Mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with bevacizumab in patients (pts) with platinum-resistant ovarian cancer: Final findings from the FORWARD II study"
Day/Time: Saturday, June 1, 1:15pm – 4:15pm CDT and discussed at the Poster Discussion Session, 4:30pm-6pm CDT in S406
Lead Author: David M. O’Malley, M.D., The Ohio State University College of Medicine
Location: Hall A
Abstract: 5520
Initial data from an investigator-sponsored trial through the National Comprehensive Cancer Network evaluating mirvetuximab in combination with gemcitabine in patients with FRα-positive recurrent epithelial ovarian, endometrial, or triple negative breast cancer will also be presented. Full dose mirvetuximab appears to combine well with gemcitabine, with a safety profile as expected for these agents and with encouraging anti-tumor activity seen in all three tumor types.

Title: "A phase 1 study of mirvetuximab soravtansine (IMGN853) and gemcitabine (G) in patients with FOLR1-positive recurrent epithelial ovarian (EOC), endometrial cancer (EC), or triple-negative breast cancer (TNBC)"
Day/Time: Saturday, June 1, 8:00am – 11:00am CDT and discussed at the Poster Discussion Session, 3:00pm-4:30pm CDT in E450
Lead Author: Mihaela C. Cristea, MD, City of Hope
Location: Hall A
Abstract: 3009
Additional information can be found at www.asco.org.

ABOUT FORWARD II

FORWARD II is a Phase 1b/2 study of mirvetuximab in combination with Avastin (bevacizumab), carboplatin or Keytruda (pembrolizumab) in patients with FRα-positive platinum-resistant or platinum-agnostic ovarian cancer, primary peritoneal, or fallopian tube tumors, as well as a triplet combination of mirvetuximab plus carboplatin and Avastin in patients with platinum-sensitive ovarian cancer.

ABOUT MIRVETUXIMAB SORAVTANSINE

Mirvetuximab soravtansine (IMGN853) is the first folate receptor alpha (FRα)-targeting ADC. It uses a humanized FRα-binding antibody to target the ADC specifically to FRα-expressing cancer cells and a potent anti-tumor agent, DM4, to kill the targeted cancer cells.

On May 15, 2019 Sanofi’s oncology franchise and robust pipeline reported that it will be featured at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, delivering against a renewed strategy to address difficult-to-treat and difficult-to-eradicate cancers, including certain types of multiple myeloma, skin cancer, breast cancer, and lung cancer (Press release, Sanofi, MAY 15, 2019, View Source [SID1234536370]).

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Four key molecules in clinical development are the pillars of Sanofi’s late-stage and emerging oncology pipeline: isatuximab, an investigational anti-CD38 monoclonal antibody; Libtayo (cemiplimab), a PD-1 checkpoint inhibitor in development with Regeneron; SAR439859, an investigational oral selective estrogen receptor degrader (SERD); and SAR408701, an investigational anti-CEACAM5 antibody drug conjugate.

"We have a strategic focus to address unmet patient needs across many therapeutic areas at Sanofi, and currently oncology makes up a sizeable portion of our late-stage pipeline," said John Reed, Head of Research and Development at Sanofi. "Our oncology pipeline is flourishing, offering a progressively expanding diversity of opportunities to help advance the treatment of a variety of cancers. We are excited to showcase this progress at ASCO (Free ASCO Whitepaper)."

Positive results in relapsed/refractory multiple myeloma

Reed continued, "We are particularly excited to share the results from our pivotal Phase 3 ICARIA-MM trial of isatuximab in patients with a difficult-to-treat relapse/refractory multiple myeloma. This is the first of multiple Phase 3 trials with isatuximab, our wholly-owned molecule under investigation for the treatment of multiple myeloma. We look forward to the presentation of data at ASCO (Free ASCO Whitepaper) and believe that the ICARIA-MM data serve as the basis for the first regulatory filings of isatuximab."

A phase 3 randomized, open-label, multicenter study comparing isatuximab, pomalidomide, and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed/refractory multiple myeloma (RRMM) (Dr. Paul Richardson; Sunday, June 2: Oral Abstract Session, 9:45-12:45 AM, ICARIA presentation,10:57-11:09 AM)
Treatment patterns in patients with multiple myeloma (MM): A retrospective study using Medicare data (Dr. Parameswaran Hari; Publication Only)
Growing body of evidence in advanced cutaneous squamous cell carcinoma

Cutaneous squamous cell carcinoma (CSCC) is one of the most commonly diagnosed skin cancers worldwide. Although the majority of patients with CSCC have a good prognosis when the cancer is found early, the cancer can be especially difficult to treat when it progresses to advanced stages.i-v New longer-term data with Libtayo offer updated efficacy and safety outcomes that add to the growing body of evidence for Libtayo in patients with metastatic CSCC or locally advanced CSCC who are not candidates for curative surgery or curative radiation. Libtayo is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.

Primary analysis of Phase 2 results of cemiplimab, a human monoclonal anti-PD-1, in patients with locally advanced cutaneous squamous cell carcinoma (Dr. Michael Migden; Saturday, June 1: Poster Display, 1:15-4:15 PM and Poster Discussion, 4:30-6:00 PM)
Phase 2 study of cemiplimab, a human monoclonal anti-PD-1, in patients with metastatic cutaneous squamous cell carcinoma (mCSCC ; Group 1): 12 month follow-up (Dr. Alexander Guminski; Monday, June 3: Poster Display, 1:15-4:15 PM)
Treatment patterns and outcomes among patients with advanced cutnaeous squamous cell carcinoma in a US community oncology setting (Dr. C. Lance Cowey; Publication Only)
Patterns of major surgeries among patients diagnosed with cutaneous squamous cell carcinoma (Chieh-I Chen; Publication Only)
Evolving evidence in breast and lung cancers

Breast cancer is the second most common form of cancer. An estimated 70% of breast cancers are estrogen receptor (ER) positive. SAR439859 is an investigational oral selective estrogen receptor degrader (SERD), a small molecule targeted therapy that binds to estrogen receptors in breast cancer cells to trigger their degradation.

Dose-escalation study of SAR439859, an oral selective estrogen receptor (ER) degrader (SERD), in postmenopausal women with ER+/HER2- metastatic breast cancer (Dr. Aditya Bardia; Poster Display, Sunday, June 2, 8:00-11:00 AM)
Phase 1/2 dose-escalation and expansion study investigating SAR439859 +/- palbociclib in postmenopausal women with estrogen receptor-positive (ER+)/HER2- metastatic breast cancer (Dr. Aditya Bardia; Poster Display, Sunday, June 2, 8:00-11:00 AM)
Carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) is a cell-surface glycoprotein highly expressed in several tumor types, including non-squamous non-small cell lung cancer (NSQ NSCLC). Approximately 20% of lung cancers have a high expression of CEACAM5.

First-in-human Phase 1 study of the antibody-drug conjugate (ADC) SAR408701 in advanced solid tumors: dose-expansion cohort of patients (pts) with non-squamous non-small cell lung cancer (NSQ NSCLC) (Dr. Anas Gazzah; Poster Display, Sunday, June 2, 8:00-11:00 AM)
Additional abstracts supported by Sanofi include:

Abstract title

Abstract number

Oral Abstract, Friday, May 31, 2:45-5:45 PM

Updated results from a randomized phase II study of cabazitaxel
(CAB) versus abiraterone (ABI) or enzalutamide (ENZ) in poor
prognosis metastatic CRPC

5003

Poster Session, Saturday, June 1, 1:15-4:15 PM

Cell-free DNA as a biomarker for taxane treatment in advanced
prostate cancer

5070

Cabazitaxel with Abiraterone Versus Abiraterone Alone
Randomized Trial for Extensive Disease Following Docetaxel: the
CHAARTED2 Trial: A trial of the ECOG-ACRIN Cancer Research
Group (EA8153)

TPS5094

HSD3B1 and Overall Survival in Men with Low-Volume Metastatic
Disease Treated with Androgen Deprivation Therapy or
Chemohormonal Therapy in the CHAARTED Randomized Trial

5020

CALGB 90203 (Alliance): Radical prostatectomy (RP) with or
without neoadjuvant chemohormonal therapy (CHT) in men with
clinically localized, high-risk prostate cancer (CLHRPC).

5079

Oral Abstract, Saturday, June 1, 3:00-6:00 PM

Association of Colon Cancer (CC) Molecular Signatures with
Prognosis and Oxaliplatin Prediction-Benefit in the MOSAIC Trial
(Multicenter International Study of Oxaliplatin/5FU-LV in the
Adjuvant Treatment of Colon Cancer)

3503

Clinical Science Symposium, Sunday, June 2, 8:00-9:00 AM

Evolutionary action score of TP53 analysis in pathologically high-
risk HPV-negative head and neck cancer from a phase II clinical
trial: NRG Oncology RTOG 0234

6010

Poster Session, Monday, June 3, 8:00-11:00 AM

Repeated centralized MDT resectability assessment during first-line
treatment in 1086 Finnish metastatic colorectal cancer (mCRC)
patients nationwide (prospective RAXO study).

3517

Combination of tissues analysis and immune infiltrate in localized
colon cancer using Using artificial intelligence in PETACC8 study

3574

Relative Contribution of Clinical and Molecular Features to
Outcome Within Low and High Risk T and N Groups in Patients
with Stage III Colon Cancers (Alliance)

3520

Is the predictive and prognostic impact of sporadic and familial
microsatellite instable stage III colon cancer different? A pooled
analysis of the PETACC8 and NCCTG N0147 (Alliance) trials

3583

About Isatuximab
Isatuximab is an investigational anti-CD38 monoclonal antibody (mAb) for the treatment of patients with relapsed/refractory multiple myeloma. Developed by Sanofi, isatuximab targets a specific epitope of CD38 capable of triggering multiple, distinct mechanisms of action that are believed to promote programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on multiple myeloma cells and is a cell surface receptor target for antibody-based therapeutics in multiple myeloma and other malignancies. The clinical significance of these findings is under investigation.

Isatuximab is currently being evaluated in multiple ongoing Phase 3 clinical trials in combination with currently available treatments across the multiple myeloma treatment continuum. Isatuximab is also under investigation for the treatment of other hematologic malignancies and solid tumors. Isatuximab is an investigational agent and its safety and efficacy have not been evaluated by the U.S. Food and Drug Administration, the European Medicines Agency, or any other regulatory authority.

About Libtayo
Libtayo is approved in the U.S., Canada and Brazil, and is under review by the European Commission following a positive opinion by the Committee for Medicinal Products for Human Use (CHMP). 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.vi The generic name for Libtayo in the U.S. 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.

Libtayo is also being investigated in potential registrational trials in non-small cell lung cancer, basal cell carcinoma and cervical cancer, along with additional trials in squamous cell carcinoma of the head and neck, melanoma, colorectal cancer, prostate cancer, multiple myeloma, Hodgkin’s lymphoma and non-Hodgkin’s lymphoma. These trials are designed to investigate Libtayo as monotherapy; in combination with conventional treatments like chemotherapy; or in combination with other investigational agents, including vaccines, oncolytic viruses and bispecific antibodies, among others. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.

IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S. PATIENTS

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.

Please see accompanying full Prescribing Information, including Medication Guide.

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.