Oncothyreon Inc. (ONTY) announced that Merck KGaA (MKGAF) has decided to continue with the development of its oncology candidate L-BLP25 (tecemotide; previously known as Stimuvax). Merck KGaA will conduct the phase III START2 study in patients with locally advanced stage III non-small cell lung cancer (:NSCLC).
Merck KGaA had in-licensed worldwide exclusive rights to L-BLP25 from Oncothyreon.
L-BLP25 had failed to meet its primary endpoint of overall survival in the multi-center, randomized, double-blind, placebo-controlled START study conducted in patients with locally advanced stage III NSCLC. However, treatment effects were seen in certain subgroups. In a predefined subgroup of patients who received concurrent chemoradiotherapy (CRT), the median overall survival was 30.8 months in the L-BLP25 arm compared with 20.6 months for placebo. This prompted Merck KGaA to initiate the START2 study.
The phase III, multicenter, randomized, double-blind, placebo-controlled, START2 study will evaluate the efficacy, safety and tolerability of L-BLP25 in patients with unresectable, locally advanced NSCLC who have either responded to or shown stable disease after at least two cycles of platinum-based concurrent CRT.
For this study, Merck KGaA has received scientific advice from the European Medicines Agency (:EMA) and has reached an agreement with the U.S. Food and Drug Administration (:FDA) on a Special Protocol Assessment (SPA).
Currently, a second phase III trial, INSPIRE, is being conducted with L-BLP25. The trial is evaluating L-BLP25 in Asian patients suffering from unresectable, stage IIIA or IIIB NSCLC who have either responded to or shown stable disease after at least two cycles of platinum-based CRT. Enrolment is currently in progress.