Improved Overall and Progression-Free Survival With First-Line Pembrolizumab in Combination With Pemetrexed and Cisplatin or Carboplatin in NSCLC
The phase III KEYNOTE-189 trial—investigating pembrolizumab (Keytruda) in combination with pemetrexed (Alimta) and cisplatin or carboplatin for the first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer (NSCLC)—met its dual primary endpoints of overall survival and progression-free survival. Based on an interim analysis conducted by the independent data monitoring committee, treatment with pembrolizumab in combination with pemetrexed plus platinum chemotherapy resulted in significantly longer overall survival and progression-free survival than pemetrexed plus platinum chemotherapy alone. The safety profile of pembrolizumab in this combination was consistent with that previously observed.
Results from KEYNOTE-189 will be presented at an upcoming medical meeting and submitted to regulatory authorities.
“KEYNOTE-189 showed significant improvement in overall survival and progression-free survival for patients receiving pembrolizumab in the first-line setting in combination with traditional chemotherapy, compared with those receiving chemotherapy alone,” said Roger M. Perlmutter, MD, PhD, President, Merck Research Laboratories. “We are deeply grateful to the KEYNOTE-189 patients and investigators for their important contributions to this landmark study, and we look forward to presenting the data in the near future.”
More About KEYNOTE-189
KEYNOTE-189 is a randomized, double-blind, placebo-controlled, phase III study investigating pembrolizumab in combination with pemetrexed and cisplatin or carboplatin compared with pemetrexed and cisplatin or carboplatin alone in patients with advanced or metastatic nonsquamous NSCLC, regardless of programmed cell death ligand 1 (PD-L1) expression. Patients had no EGFR or ALK genomic tumor aberrations, and had not previously received systemic therapy for advanced disease. The KEYNOTE-189 study was done in collaboration with Eli Lilly and Company, the makers of pemetrexed.
The dual primary endpoints are overall survival and progression-free survival; secondary endpoints include overall response rate and duration of response.
The study enrolled 614 patients randomized 2:1 to receive either pembrolizumab at a 200-mg fixed dose every 3 weeks plus pemetrexed at 500 mg/m2 (with vitamin supplementation) plus cisplatin at 75 mg/m2 or carboplatin at AUC 5 on day 1 every 3 weeks for 4 cycles followed by pembrolizumab at 200 mg plus pemetrexed at 500 mg/m2 every 3 weeks or pembrolizumab placebo at 200 mg plus pemetrexed at 500 mg/m2 (with vitamin supplementation) plus cisplatin at 75 mg/m2 or carboplatin at AUC 5 on day 1 every 3 weeks for 4 cycles followed by pembrolizumab placebo at 200 mg plus pemetrexed at 500 mg/m2 every 3 weeks, until disease progression, unacceptable toxicity, physician decision, or withdrawal of consent. Patients on the control arm who experienced disease progression, verified by central independent review, were permitted to undergo treatment assignment unblinding and crossover to receive open-label pembrolizumab.
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