A collaboration between Gilead Sciences and Dragonfly Therapeutics was announced May 2, with an end goal of bringing Dragonfly’s DF7001 natural killer (NK) engager program designed for patients with cancer or inflammatory diseases to fruition.
Gilead Combo Therapy Hit with FDA Hold Over Serious Adverse Events
Acute Myeloid Leukemia (AML), CD47 Protein, Clinical Trials, Combination Therapies, Diffuse large B-cell lymphoma (DLBCL), FDA/Regulatory, Gilead, Head & Neck Squamous Cell Carcinoma (HNSCC), Malignancies, Myelodysplastic Syndromes, Partial Clinical Hold, R&D, Triple Negative Breast Cancer (TNBC)The U.S. Food and Drug Administration placed a partial clinical hold on studies conducted by Gilead Sciences assessing the combination of magrolimab plus azacitidine due to concerns of unexpected serious adverse events between study arms.
Opdivo/Yervoy Combo Fails to Meet Endpoints in Head and Neck Cancer
Blockbusters, Bristol Myers Squibb, Checkpoint Inhibitors, Clinical Trial Endpoints, Clinical Trials, Head & Neck Cancer, Head & Neck Squamous Cell Carcinoma (HNSCC), Overall Survival (OS), PD-1/PD-L1 inhibitors, R&D, Secondary EndpointsBristol Myers Squibb shared new details on the global biopharmaceutical firm’s Phase III research on a potential first-line treatment for people who have been diagnosed with recurrent or metastatic squamous cell carcinoma of the head and neck.
GlaxoSmithKline halted two mid-stage studies assessing feladilimab combined with Merck’s Keytruda as a potential treatment in different oncology settings.
AstraZeneca reported that the company’s Phase III KESTREL trial of Imfinzi (durvalumab) failed to meet the primary endpoint of improving overall survival compared to the EXTREME treatment regimen, which was chemotherapy plus cetuximab, a standard of care.
The U.S. Food and Drug Administration requested ALX Oncology complete a standard safety study, which amounts to a partial clinical hold on a Phase II study pairing the company’s CD47 inhibitor ALX148 with Merck’s Keytruda in Head & Neck Squamous Cell Carcinoma (HNSCC).
Moderna released interim data from the expansion cohort of an ongoing Phase I trial of the company’s mRNA personalized cancer vaccine mRNA-4157, which is being tested in combination with Merck’s checkpoint inhibitor Keytruda (pembrolizumab).
ALX Oncology is partnering with pharma giant Merck to evaluate a combination of the CD47 inhibitor ALX148 with the blockbuster Keytruda as a potential treatment for patients with head and neck squamous cell carcinoma (HNSCC).
Vaccinex Inc. will pair the company’s lead asset pepinemab with Merck & Co.’s vaunted checkpoint inhibitor Keytruda.