Oncothyreon jumps on tecemotide Phase III plans

Oncothyreon Inc. (NASDAQ:ONTY) jumped $0.38 (21%) to $2.18 on Wednesday after Merck KGaA (Xetra:MRK) said it will begin the Phase III START2 trial of tecemotide ( L-BLP25) to treat non-small cell lung cancer (NSCLC) despite the compound missing the primary endpoint in the Phase III START trial in NSCLC. Last December, the partners said tecemotide missed the primary endpoint of improving overall survival (OS) vs. placebo in START to treat unresectable, locally advanced stage III NSCLC. The partners said the decision to begin START2 is based on the outcome of START, in which tecemotide led to a median OS of 30.8 months vs. 20.6 months for placebo in a predefined subgroup of patients who received concurrent chemoradiotherapy (p=0.016) (see BioCentury Extra, Dec. 19, 2012).

Oncothyreon said Merck's Merck Serono S.A. division has received an SPA from FDA and scientific advice from EMA for START2, which will enroll patients with unresectable, locally advanced stage III NSCLC who have had a response or stable disease after at least two cycles of platinum-based concurrent chemotherapy. Merck declined to disclose a timeline for the start of START2. ...