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FDA Approves Pembrolizumab for Frontline PD-L1+ NSCLC

Jason M. Broderick @jasoncology
Published: Monday, Oct 24, 2016

“Keytruda improved survival, compared to traditional chemotherapy, in patients with non–small cell lung cancer whose tumors express high levels of PD-L1,” Roger M. Perlmutter, MD, PhD, president, Merck Research Laboratories, the manufacturer of pembrolizumab, said in a statement. “The approval of Keytruda for the first-line treatment of metastatic non-small cell lung cancer has the potential to change the treatment landscape for these patients.”

The most frequently observed grade 3 to 5 AEs with pembrolizumab were decreased appetite, fatigue, nausea, rash, diarrhea, asthenia, stomatitis, and anemia. Three treatment-related deaths occurred within each pembrolizumab arm. The most common immune-mediate AEs with pembrolizumab in the 2 mg/kg and 10 mg/kg arms, respectively, were hypothyroidism (8% and 8%), hyperthyroidism (4% and 6%), and pneumonitis (5% and 4%).

References:
  1. Reck M, Rodgriguez-Abreu D, Robinson AG, et al. KEYNOTE-024: Pembrolizumab (pembro) vs platinum-based chemotherapy (chemo) as first-line therapy for advanced NSCLC with a PD-L1 tumor proportion score (TPS) ≥50%. Presented at: 2016 ESMO Congress; October 7-11, 2016; Copenhagen, Denmark. Abstract LBA8.
  2. Reck M, Rodgriguez-Abreu D, Robinson AG, et al. Pembrolizumab versus Chemotherapy for  PD-L1–Positive Non–Small-Cell Lung Cancer [published online October 9, 2016]. N Engl J Med. DOI: 10.1056/NEJMoa1606774.
  3. Herbst RS, Baas P, Kim D-W, et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. Lancet. 2016;387(10027):1540-1550.

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