Merck KGaA ( '>MKGAF ) recently presented detailed results on its oncology candidate L-BLP25, from the phase III study, START (Stimulating Targeted Antigenic Responses To NSCLC). Results from this study were initially presented in Dec 2012.
L-BLP25 failed to meet its primary endpoint of overall survival in the multi-center, randomized, double-blind, placebo-controlled study conducted in patients with locally advanced stage III non-small cell lung cancer (:NSCLC).
The median overall survival was 25.6 months for L-BLP25 compared with 22.3 months for placebo.
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 for L-BLP25 compared with 20.6 months for placebo.
Injection site reactions were seen in 17.3% in L-BLP25 versus 11.9% in placebo. Flu-like symptoms were seen in 10.9% in L-BLP25 versus 9.9% in placebo. Potential immune-related diseases were similar for both groups.
Merck KGaA had in-licensed worldwide exclusive rights for L-BLP25 from Oncothyreon Inc (ONTY).
Data from the START study will be presented at the annual meeting of the American Society of Clinical Oncology (TATD). 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 had a response or stable disease after at least two cycles of platinum-based CRT.
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