From Business Wire
Merck announced on August 20, 2018, that the U.S. Food and Drug Administration (FDA) has approved an expanded label for pembrolizumab/KEYTRUDA®, Merck’s anti-PD-1 therapy, in combination with pemetrexed (ALIMTA®) and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations, based on results of the KEYNOTE-189 trial. In the pivotal, Phase 3 KEYNOTE-189 trial of patients regardless of PD-L1 tumor expression status, KEYTRUDA in combination with pemetrexed and platinum chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival, reducing the risk of death by half compared to chemotherapy alone. The study also showed a significant improvement in progression-free survival (PFS) compared to chemotherapy alone. Data from KEYNOTE-189 support that KEYTRUDA is changing survival expectations for these patients.
“KEYTRUDA is rapidly becoming a foundation for the treatment of appropriate patients with metastatic non-small cell lung cancer,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “Today’s approval of the expanded label for KEYTRUDA based on data from the KEYNOTE-189 trial is an important milestone, and reinforces our steadfast commitment to improving survival outcomes, and providing hope, for more patients with lung cancer.”
“Over the last few years, we’ve seen significant clinical advances and an incredible shift in the way we approach the treatment of people diagnosed with metastatic non-small cell lung cancer,” said Dr. Shirish Gadgeel, professor in thoracic oncology at the University of Michigan Rogel Cancer Center. “As a practicing physician, I welcome today’s news, as KEYTRUDA in combination with pemetrexed and platinum chemotherapy significantly prolonged overall survival and progression-free survival in the KEYNOTE-189 trial, compared with chemotherapy alone.”
FDA full approval of pembrolizumab
KEYTRUDA in combination with pemetrexed and carboplatin was first approved in 2017 under the FDA’s accelerated approval process for the first-line treatment of patients with metastatic nonsquamous NSCLC, based on tumor response rates and progression-free survival data from the Phase 2 study (KEYNOTE-021, Cohort G1). In accordance with the accelerated approval process, continued approval was contingent upon verification and description of clinical benefit, which has now been demonstrated in KEYNOTE-189 and has resulted in the FDA converting the accelerated approval to full (regular) approval. KEYTRUDA is the first anti-PD-1 approved in the first-line setting as both combination and monotherapy in certain patients with metastatic NSCLC.