Frontline Pembrolizumab Combo Submitted for FDA Approval in Squamous NSCLC


“The FDA has received a supplemental biologics license application (sBLA) seeking approval for pembrolizumab (Keytruda) in combination with standard chemotherapy as a treatment for patients with metastatic squamous non–small cell lung cancer (sNSCLC).

“The application is based on findings from the phase III KEYNOTE-407 trial (NCT02775435),  which evenly randomized 560 treatment-naive patients with metastatic squamous NSCLC to pembrolizumab combined with carboplatin/paclitaxel or nab-paclitaxel (Abraxane), carboplatin/paclitaxel alone, or nab-paclitaxel alone. The coprimary endpoints were overall survival (OS) and progression-free survival (PFS). Secondary endpoints included objective response rate (ORR) and duration of response.”

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