Oncothyreon Inc. (ONTY) and its partner, Merck KGaA (MKGAY) recently presented disappointing data from a phase III trial on their oncology candidate, L-BLP25 (formerly referred to as Stimuvax). L-BLP25 is being developed for the treatment of unresectable stage III non-small cell lung cancer (:NSCLC).
The multi-center, randomized, double-blind, placebo-controlled START trial enrolled more than 1,500 patients. The trial evaluated efficacy, safety and tolerability of L-BLP25 in patients with unresectable, stage IIIA or IIIB NSCLC who have had a response or stable disease after at least two cycles of platinum-based chemoradiotherapy. It was found that the use of L-BLP25 did not improve overall survival (:OS) significantly and did not meet the primary end point.
However, in certain subgroups, treatment benefit was observed. The companies plan to analyze the data further. Detailed data from the START trial will be presented at upcoming scientific meetings.
Currently, a second phase III trial, INSPIRE, is ongoing. The trial is evaluating L-BLP25 in patients of Asian heritage suffering from unresectable, stage IIIA or IIIB NSCLC who have had a response or stable disease after at least two cycles of platinum-based chemoradiotherapy.
In 2007, Merck KGaA had gained development and commercialization rights to L-BLP25 from Oncothyreon. In Japan, Merck KGaA has a co-development and marketing agreement with a Japanese pharma company, Ono Pharmaceutical Co. Ltd.
We currently have a Neutral recommendation on Oncothyreon. The stock carries a Zacks #3 Rank (Hold) in the short run.
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