Oncothyreon slides on tecemotide Japanese trial miss

Oncothyreon Inc. (NASDAQ:ONTY) slid $0.48 (17%) to $2.30 on Tuesday after disclosing in an SEC filing that partner Merck KGaA (Xetra:MRK) said tecemotide ( L-BLP25) missed the primary overall survival (OS) endpoint vs. placebo in a 178-patient, Japanese Phase I/II trial to treat non-small cell lung cancer (NSCLC). The majority of patients received concurrent chemoradiotherapy. According to Oncothyreon, Merck said it "will review the implications" of the data for the ongoing tecemotide program.

Earlier this year, the pharma started the Phase III START2 trial to evaluate tecemotide with concurrent chemoradiotherapy to treat unresectable, locally advanced NSCLC. Tecemotide is also in the similar Phase III INSPIRE trial in unresectable stage III NSCLC patients in China, Hong Kong, Korea, Singapore and Taiwan. The START2 trial came after Merck said tecemotide improved OS in a predefined subgroup of patients who received concurrent chemoradiotherapy in the Phase III START trial, despite missing the primary OS endpoint in the overall population of NSCLC patients with unresectable, locally advanced disease. ...