Oncothyreon Inc. (ONTY - Snapshot Report) announced that Merck KGaA 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.
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