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]).

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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.

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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.

On May 13, 2020 Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported that updated clinical data from an investigator-sponsored Phase 1/2 trial led by Baylor College of Medicine were selected for presentation during a poster session at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Marker Therapeutics, MAY 13, 2020, View Source [SID1234557948]). ASCO (Free ASCO Whitepaper) 2020 will be held virtually from Friday, May 29 through Sunday, May 31, 2020. The data will be presented by lead investigator, Brandon G. Smaglo, M.D., FACP.

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Presentation Details

Title: "A phase I trial targeting advanced or metastatic pancreatic cancer using a combination of standard chemotherapy and adoptively transferred nonengineered, multiantigen specific T cells in the first-line setting (TACTOPS)"
Authors: Smaglo BG, et al.
Session Type: Poster Session
Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Abstract: 4622
Poster: 230

The presentation will be available on demand to ASCO (Free ASCO Whitepaper) registrants beginning May 29, 2020 at 8:00 a.m. ET. The poster will be available in the Investors section of the Company’s website at markertherapeutics.com.

On May 13, 2020 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), an epigenetics company developing simple, easy to use and cost effective blood tests to help diagnose a range of cancers, reported that it will present three abstracts at the 2020 ASCO (Free ASCO Whitepaper) Annual Meeting (Press release, VolitionRX, MAY 13, 2020, View Source [SID1234557947]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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ASCO Abstract e20078 "Circulating nucleosomes in hematological malignancy"
The first abstract presented announces initial data demonstrating the ability of Volition’s sample-enrichment tool, Nu.Q Capture, to separate short and long nucleosomes in clinical colorectal cancer samples to enable the concentration of tumor-derived nucleosomal markers prior to analysis. The other two abstracts presented provide new performance data for Volition’s Nucleosomics Nu.Q technology in the early detection of lung cancer and blood cancer.

E13534: Enrichment of circulating tumor DNA from cell free DNA of Hematopoietic origin

Data from this pilot study, the first published results for Volition’s Nu.Q Capture program, showed that Nu.Q Capture technology successfully demonstrated enrichment of circulating tumor nucleosomes and tumor DNA ("ctDNA"). The data clearly showed the separation of short and long nucleosomes from both cancer cell lines in a laboratory setting, and in clinical colorectal cancer patients versus healthy controls.

Dr. Mark Eccleston, Business Development Director and a founding scientist at Volition, said: "Effective removal of most ‘healthy/long’ nucleosomes creates an enriched sample allowing for more accurate measurement of cancer nucleosomes. Similarly, the removal of most ‘healthy/long’ nucleosome-associated DNA can also enhance detection of cancer using ctDNA technologies. These data are a really positive sign of the potential of Nu.Q Capture as a valuable tool to enable improved and earlier detection of cancer."

For more information about this abstract please watch this short video: View Source

E15542: Performance of a Nu.Q-H3.1 assay for lung cancer detection
This study, conducted in conjunction with Dr. Anne Sibille and team of Liege University Hospital, Belgium, aimed to assess the performance of a Nu.Q assay in discriminating both between lung cancer and healthy controls, and between lung cancer and Chronic Obstructive Pulmonary Disease ("COPD").

A pilot study of 142 subjects demonstrated that Nu.Q assays could not only discriminate lung cancer versus healthy controls with an Area Under the Curve ("AUC") of 88%, but also between lung cancer and COPD with an AUC of 85%. The AUC is an industry accepted measure of the effectiveness of an assay whereby 100% is the most accurate.

Commenting on this study, Dr. Marielle Herzog, Research and Development Director at Volition, said: "Lung cancer is not only the most prevalent cancer, but it is also the most deadly, responsible for over 1.75 million deaths worldwide each year. Its diagnosis currently relies on invasive methods and often occurs at a late stage of disease, explaining its poor outcome. Our hope is that a blood-based test could aid earlier diagnosis. Based on these encouraging results, we believe further studies with larger numbers of patients should be performed to confirm and validate the usefulness of these biomarkers and models."

E20078: Circulating nucleosomes in hematological malignancy
This pilot study investigated the circulating levels of intact nucleosomes containing the histone H3.1 isoform (Nu.Q-H3.1) in a variety of solid tumors including Non Hodgkin Lymphoma ("NHL"), Acute Myeloid Leukemia ("AML"), Acute Lymphocytic Leukemia ("ALL"), and in healthy subjects.

The results showed elevated levels of Nu.Q-H3.1 in patients diagnosed with cancers. Only 14 of 271 patients with a solid tumor had levels >200ng/ml. In contrast, the median Nu.Q-H3.1 levels observed for patients with NHL, AML and ALL were 276, 284 and 585ng/ml, respectively. The median nucleosome level in 62 healthy subjects was 40ng/ml and the highest level was 198ng/ml. The Area Under the Curve ("AUC") for all patients diagnosed with NHL, AML or ALL (n=54) vs healthy subjects was 91% with a sensitivity of 74% at 95% specificity.

Lead author, Dr. Jason Terrell, Chief Medical Officer at Volition, commented: "Elevated nucleosome levels have been reported for a number of diseases. These encouraging early results indicate that levels of Nu.Q-H3.1 are particularly elevated in haematological cancers. These data show that Nu.Q technology may be a useful diagnostic tool warranting further study."

For further information about this abstract please watch this video presentation:
View Source

Abstracts will be available to view starting at 5:00 pm ET on May 13, 2020 on the ASCO (Free ASCO Whitepaper) Meeting Library.

On May 13, 2020 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, autoimmune, metabolic and other major diseases, reported with Eli Lilly and Company (NYSE: LLY) that the Phase 2 TYVYT (sintilimab injection) ORIENT-2 study in China met its primary endpoint of overall survival (OS) (Press release, Innovent Biologics, MAY 13, 2020, View Source [SID1234557946]).

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The randomized study, which evaluated TYVYT monotherapy compared to chemotherapy (paclitaxel or irinotecan) as a second-line treatment for patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC), demonstrated a statistically significant improvement in OS. The safety profile of TYVYT is consistent with previously reported TYVYT study results, and no new safety signals were identified. The detailed results will be reported in an ASCO (Free ASCO Whitepaper) 2020 poster discussion session (No. 4511).

Innovent and Lilly plan to discuss these results with the Drug Evaluation Center (CDE) of the National Medical Products Administration (NMPA) in China.

The principal investigator of the ORIENT-2 study, Professor Jianming Xu from the Fifth Medical Center of the PLA General Hospital, stated: "The incidence of ESCC in Asian countries is much higher than that in Western countries. The current standard of treatment is still based on traditional chemotherapy and radiation therapy. Traditional chemotherapy drugs have shown a very limited effect on the second-line treatment of patients with advanced ESCC. Over the past 10 years, immunotherapy has made tremendous progress in multiple tumor types, but the drug development advancements in treating ESCC has been slower and there remains a huge unmet medical need. The ORIENT-2 study confirmed that TYVYT can prolong overall survival in the second-line treatment of people with ESCC. We have seen that sintilimab is more efficacious than chemotherapy and we are hopeful that TYVYT has the potential to be a new treatment option for these patients."

Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent, stated: "TYVYT was approved by the NMPA in 2018 for the treatment of relapsed or refractory classic Hodgkin’s lymphoma after second-line or later systemic chemotherapy. We currently have more than 20 clinical studies ongoing to evaluate the efficacy of TYVYT in other types of tumors. The results of the ORIENT-2 study demonstrate the potential of TYVYT to treat patients with advanced ESCC in the second-line setting. We are also conducting a Phase 3 trial to evaluate TYVYT combined with chemotherapy (paclitaxel and cisplatin) as a first-line treatment of patients with advanced, recurrent or metastatic ESCC. We hope these clinical trials can provide more effective treatment options for clinicians and benefit more ESCC patients."

"From Hodgkin’s lymphoma, lung cancer to esophageal cancer, we are glad to see that TYVYT’s clinical efficacy has been demonstrated in multiple tumor types," said Dr. Li Wang, Senior Vice President of Lilly China and Head of Lilly China Drug Development and Medical Affairs Center. "We are thankful to the patients and their families, investigators and clinical trial sites participating in the ORIENT-2 study, and to our colleagues from Innovent. We would not have seen these encouraging results without their efforts. We look forward to working to bring TYVT as a new treatment option to people with ESCC in China."

About the ORIENT-2 Study

ORIENT-2 is a randomized, open-label, Phase 2 study to evaluate the efficacy and safety of TYVYT with paclitaxel or irinotecan in patients with advanced or metastatic ESCC who failed first-line treatment (ClinicalTrials.gov, NCT03116152). The primary endpoint was OS.

A total of 190 subjects were enrolled in this study. They were randomly assigned 1:1 to receive TYVYT or the investigator’s choice of paclitaxel or irinotecan, until disease progression, unacceptable toxicity, withdrawal of consent, death, or other reasons stated in the protocol, whichever occurs first.

About advanced ESCC

The incidence and mortality of esophageal cancer in China rank third and fourth, respectively. Squamous cell carcinoma accounts for approximately 90 percent of all esophageal cancer cases. A considerable proportion of patients with early-stage ESCC will develop recurrence or metastatic disease following resection surgery. Currently, the standard treatment for ESCC is limited to traditional chemotherapy and radiation therapy. There are few treatment options and no targeted therapies for ESCC, resulting in a large unmet clinical need.

About TYVYT (Sintilimab Injection)

TYVYT (sintilimab injection), an innovative drug developed with global quality standards jointly developed by Innovent and Lilly in China, has been granted marketing approval by the NMPA for relapsed or refractory classic Hodgkin’s lymphoma after second-line or later systemic chemotherapy, and included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. TYVYT is the only PD-1 inhibitor that has been included in the new Catalogue of the National Reimbursement Drug List (NRDL), in November 2019. In April 2020, the NMPA accepted the supplemental new drug application for TYVYT in combination with ALIMTA (pemetrexed) and platinum as first-line therapy in non-squamous non-small cell lung cancer (NSCLC). In May 2020, TYVYT combined with Gemzar (gemcitabine for injection) and platinum chemotherapy met the predefined primary endpoint in the Phase 3 ORIENT-12 study as first-line therapy in patients with locally advanced or metastatic squamous NSCLC.

TYVYT is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-Ligand 1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies with TYVYT to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registration or pivotal clinical trials.