Nektar Therapeutics outlined a strategic reorganization plan that includes cutting 70 percent of the company’s workforce, only weeks after Bristol Myers Squibb abandoned its clinical collaboration program with Nektar on bladder cancer and renal cell carcinoma.
AACR: Monday’s Stars Include Affimed, Hoth and Blueprint
American Association for Cancer Research (AACR), Antibodies, Checkpoint Inhibitors, Clinical Trials, DNA, Efficacy Data, Epidermal Growth Factor Receptor-Mutated (EGFRm) Non-Small Cell Lung Cancer (NSCLC), Hodgkin Lymphoma, Microsatellite instability-high (MSI-H) cancer, Non-Hodgkin Lymphoma, PD-1/PD-L1 inhibitors, R&D, Solid Tumors, TherapeuticsThe American Association for Cancer Research (AACR) Annual Meeting is running from April 7-13 in New Orleans, with hundreds of presentations on cutting-edge cancer research. The presentations run the gamut from preclinical studies to late-stage clinical trials. BioSpace looks at some of the preclinical and early-stage studies presented.
Checkpoint inhibitor pioneer James P. Allison, who won the 2018 Nobel Prize in Medicine, will helm a new research and innovation hub at The University of Texas MD Anderson Cancer Center that is focused on developing new immunotherapy breakthroughs in oncology.
In Expected Decision, FDA Rejects Lilly’s Sintilimab in NSCLC
Alliances, Biologics License Application (BLA), Business, Checkpoint Inhibitors, Clinical Trials, Complete Response Letter, EGFR tyrosine kinase inhibitors (TKI), Eli Lilly, FDA, Hepatocellular Carcinoma, Non-Squamous Non-Small Cell Lung Cancer (NSCLC), PD-1 Inhibitors, R&D, TherapeuticsThe U.S. Food and Drug Administration rejected Eli Lilly’s Biologics License Application, issuing a Complete Response Letter for the company’s PD-1 checkpoint inhibitor sintilimab.
Hot off the heels of the company’s milestone approval for the unique checkpoint inhibitor Opdualag, Bristol Myers Squibb forged an oncology drug discovery and development deal valued at more than $1 billion with Volastra Therapeutics.
FDA approves BMS’ first-in-class LAG-3-blocking antibody combination for advanced melanoma
Approvals, Bristol Myers Squibb, Checkpoint Inhibitors, Clinical Trial Endpoints, Clinical Trials, FDA, First-In-Class, LAG-3 protein, Metastatic Melanoma, PD-1/PD-L1 inhibitors, Primary Endpoints, Progression-Free Survival (PFS), R&DBristol Myers Squibb’s Opdualag – a new, first-in-class, fixed-dose combination of nivolumab and relatlimab, administered as a single intravenous infusion – was approved by the U.S. Food and Drug Administration for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.
Two-year follow-up data were reported from the Phase III CheckMate -9ER trial of Bristol Myers Squibb’s checkpoint inhibitor Opdivo (nivolumab) and Exelixis’ Cabometyx (cabozantinib) in the first-line treatment of advanced renal cell carcinoma.
FDA’s ODAC Says Lilly & Innovent Must Run U.S. Trial
Business, Checkpoint Inhibitors, China, Clinical Trial Endpoints, Clinical Trials, Ethnicity, FDA/Regulatory, Lung Cancer, Oncologic Drugs Advisory Committee (ODAC), PD-1 Inhibitors, Primary Endpoints, Progression-Free Survival (PFS), R&D, Therapeutics, United StatesThe Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) recommended that Eli Lilly and Co. and Innovent Biologics Inc. conduct a clinical trial applicable to the U.S. population for the lung cancer drug sintilimab. The U.S. FDA previously raised concerns over a clinical trial conducted entirely in China focused on a single ethnic group.
AstraZeneca reported what the company called “unprecedented survival,” in the HIMALAYA Phase III trial using a single priming dose of tremelimumab added to the anti-PD-L1 checkpoint inhibitor Imfinzi (durvalumab) compared to Bayer’s Nexavar (sorafenib) as a first-line treatment for unresectable hepatocellular carcinoma (HCC) patients who had not received previous systemic therapy and as a result, were not eligible for localized treatment.
Roche announced promising results for the company’s anti-TIGIT checkpoint inhibitor tiragolumab in PD-L1-positive metastatic non-small cell lung cancer.