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Tuesday, 01/16/2018 10:09:36 AM

Tuesday, January 16, 2018 10:09:36 AM

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Gangbusters > solid FDA news: Merck's KEYTRUDA(R) (pembrolizumab) Significantly Improved Overall Survival and Progression-Free Survival as First-Line Treatment in Combination with Pemetrexed and Platinum Chemotherapy for Patients with Metastatic Nonsquamous Non-Small Cell Lung Cancer (KEYNOTE-189)
3 hours 11 minutes ago - DJNF
KEYTRUDA is First PD1 Inhibitor in Combination to Show Overall Survival in NSCLC

KENILWORTH, N.J.--(BUSINESS WIRE)--January 16, 2018--

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-189 trial investigating KEYTRUDA(R) (pembrolizumab), Merck's anti-PD-1 therapy, in combination with pemetrexed (Alimta(R) ) and cisplatin or carboplatin, for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS). Based on an interim analysis conducted by the independent Data Monitoring Committee, treatment with KEYTRUDA in combination with pemetrexed plus platinum chemotherapy resulted in significantly longer OS and PFS than pemetrexed plus platinum chemotherapy alone. The safety profile of KEYTRUDA 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 KEYTRUDA in the first-line setting in combination with traditional chemotherapy, compared with those receiving chemotherapy alone," said Dr. Roger M. Perlmutter, 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."

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