Oncothyreon Inc. (ONTY)'s Lung Cancer Drug EMR 63325-009 Misses Primary Endpoint In Phase 1 Study
8/20/2014 6:12:35 AM
Merck KGaA (NYSE: MRK), Darmstadt, Germany, has informed Oncothyreon Inc. (Nasdaq: ONTY) that a randomized Phase 1/2 study, EMR 63325-009, of tecemotide compared to placebo in Japanese patients with Stage III non-small cell lung cancer did not meet its primary endpoint of an improvement in overall survival, and no treatment effect was seen in any of the secondary endpoints (progression free survival, time to progression or time to failure). A preliminary analysis of adverse events has not identified a clinically meaningful difference between study groups. The study was not powered to show statistical significance between the two arms. The study enrolled 178 patients in Japan, of which 94% had received concurrent chemoradiotherapy.
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