Junshi Biosciences announced that the Phase III clinical trial the Chinese pharmaceutical company is conducting alongside California-based Coherus BioSciences on a potential non-small cell lung cancer (NSCLC) drug is showing positive preliminary results.
The U.S. Food and Drug Administration approved the combination of Merck’s anti-PD-1 therapy Keytruda plus Eisai’s orally available multiple receptor tyrosine kinase inhibitor Lenvima for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
Findings from the Phase III EMPOWER-Lung 3 trial, announced Aug. 5 by Regeneron Pharmaceuticals and Sanofi, show that a combination regimen comprising the PD-1 inhibitor Libtayo and platinum-doublet chemotherapy significantly improved overall survival compared with chemotherapy alone in patients with metastatic or locally advanced non-small cell lung cancer (NSCLC).
The U.S. Food and Drug Administration approved an expanded label for Merck’s anti-PD-1 therapy Keytruda as monotherapy for the treatment of patients with locally advanced cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.
The Oncologic Drugs Advisory Committee (ODAC), as part of the U.S. Food and Drug Administration, voted 13-4 that a regulatory decision on Incyte’s PD-1 inhibitor retifanlimab for the treatment of advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) should be deferred until further data are available from the clinical trial POD1UM-303.
Regeneron and Sanofi broke new ground in treating advanced basal cell carcinoma with their anti-PD-1 inhibitor, Libtayo.
Merck announced positive data from the Phase III KEYNOTE-355 trial looking at the company’s checkpoint inhibitor Keytruda (pembrolizumab) in combination with chemotherapy as a first-line treatment for metastatic triple-negative breast cancer.
Paris-based Sanofi and Tarrytown, New York-based Regeneron Pharmaceuticals announced topline data for the companies’ pivotal Phase II trial of the PD-1 checkpoint inhibitor Libtayo (cemiplimab) in advanced basal cell carcinoma patients that had progressed on or could not tolerate previous hedgehog pathway inhibitor therapies.
Merck’s vaunted checkpoint inhibitor Keytruda picked up another regulatory approval. The U.S. Food and Drug Administration approved an additional recommended dosage of 400 mg every six weeks for the anti-PD-1 therapy across all adult indications, including as a monotherapy and in combination treatments.
Merck & Co. reported that the checkpoint inhibitor Keytruda had mixed results as a first-line treatment of advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.