#Keynote 189 trial
MSD is also obligated to protect the rights and privacy of trial participants and, as such, has a procedure in place for evaluating and fulfilling requests for sharing company clinical trial data with qualified external scientific researchers. Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA (MSD) is committed to providing qualified scientific researchers access to anonymized data and clinical study reports from the company’s clinical trials for the purpose of conducting legitimate scientific research. Takayasu Kurata: Personal fees from AstraZeneca, MSD, Eli Lilly, Chugai Pharmaceutical, Ono Pharmaceutical, Bristol-Myers Squibb, Boehringer Ingelheim, and Pfizer Grants from AstraZeneca, MSD, Chugai Pharmaceutical, Takeda, and Bristol-Myers Squibb. Fabricio Souza: Employee of Merck & Co., Inc.
Eiki Ichihara: Honoraria from Boehringer Ingelheim Research support from MSD. Yoshihiro Hattori: Lecture fees from Taiho Pharmaceutical Grants from Ono Pharmaceutical and MSD. Kazuo Kasahara: Grants from Boehringer Ingelheim. Toshiaki Takahashi: Grants and personal fees from AstraZeneca KK, Chugai Pharmaceutical, Eli Lilly Japan KK, Ono Pharmaceutical, and MSD KK Grants from Pfizer Japan Inc Personal fees from Boehringer Ingelheim Japan, Inc and Roche Diagnostics KK. Takaaki Tokito: Personal fees from AstraZeneca, Chugai Pharmaceutical, MSD, and Boehringer Ingelheim. Makoto Nishio: Honoraria for lectures and consulting from Ono Pharmaceutical, Bristol-Myers Squibb, Pfizer, Chugai Pharmaceutical, Eli Lilly, Taiho Pharmaceutical, AstraZeneca, Boehringer Ingelheim, MSD, and Novartis Research support from MSD, Novartis, Ono Pharmaceutical, Chugai Pharmaceutical, Bristol-Myers Squibb, Taiho Pharmaceutical, Eli Lilly, AstraZeneca, and Pfizer. Naoyuki Nogami: Honoraria from AstraZeneca, Chugai Pharmaceutical, Pfizer Japan Inc, Eli Lilly Japan KK, Ono Pharmaceutical, Taiho Pharmaceutical, MSD KK, Kyowa Kirin, Bristol-Myers Squibb KK, and Nippon Boehringer Ingelheim. Hidehito Horinouchi: Lecture fees, honoraria, or other fees from Eli Lilly, AstraZeneca, Kyowa Kirin, MSD, Ono Pharmaceutical, and Bristol-Myers Squibb Research funds from Chugai Pharmaceutical, Daiichi Sankyo, AstraZeneca, MSD, Ono Pharmaceutical, Bristol-Myers Squibb, and Genomic Health.
#Keynote 189 plus
Efficacy and safety outcomes were similar to those from the global study and support first-line therapy with pembrolizumab plus pemetrexed-platinum in Japanese patients with nonsquamous NSCLC without EGFR/ ALK alterations. Grade 3/4 AE occurred in 72% vs 60% of patients in the pembrolizumab vs placebo arms 40% vs 20% had immune-mediated AE, and 4% vs 0% had infusion reactions. There were no grade 5 adverse events (AE). At data cutoff ( median time from randomization to data cutoff, 18.5 months), the median OS was not reached in the pembrolizumab plus pemetrexed-platinum arm the median OS was 25.9 (95% confidence interval, 11.9‒29.0) months in the placebo plus pemetrexed-platinum arm (hazard ratio. Forty Japanese patients enrolled (pembrolizumab, n = 25 placebo, n = 15). All patients received pemetrexed 500 mg/m 2 plus the investigator’s choice of cisplatin or carboplatin Q3W for four cycles, followed by maintenance pemetrexed 500 mg/m 2 Q3W (all intravenous). Patients were randomized 2:1 to intravenous pembrolizumab 200 mg or placebo every 3 weeks (Q3W) for up to 35 cycles. We present results of Japanese patients enrolled in the KEYNOTE-189 global and Japan extension studies. Pembrolizumab plus pemetrexed-platinum significantly improved overall survival (OS) and progression-free survival (PFS) with manageable safety compared with placebo plus pemetrexed-platinum in patients with previously untreated metastatic nonsquamous non–small-cell lung cancer (NSCLC) without EGFR/ALK alterations in the global, randomized, double-blind, phase 3 KEYNOTE-189 study.
0 kommentar(er)
