Merck KGaA had in-licensed worldwide exclusive rights to tecemotide from Oncothyreon.
The phase III, multicenter, randomized, double-blind, placebo-controlled START2 study (n=1000) will evaluate the efficacy, safety and tolerability of tecemotide in patients with unresectable, locally advanced non-small cell lung cancer (:NSCLC) who have either responded to or shown stable disease after at least two cycles of platinum-based concurrent chemoradiotherapy (CRT).
The primary endpoint of the study is overall survival and the secondary endpoints include time to symptom progression, progression-free survival and time to progression.
For this study, Merck KGaA has received scientific advice from the European Medicines Agency (EMA.TO) and has reached an agreement with the U.S. Food and Drug Administration (:FDA) on a Special Protocol Assessment (SPA).
Merck KGaA initiated the START2 study based on the outcome of the earlier START trial. Tecemotide 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 CRT, the median overall survival was 30.8 months in the tecemotide arm compared with 20.6 months for placebo.
Tecemotide is also being evaluated in another phase III study, INSPIRE. The trial is evaluating tecemotide 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.
We believe investor focus will remain on updates from these studies. Oncothyreon and Merck KGaA carry a Zacks Rank #3 (Hold). Investors looking for better-ranked stocks in the biopharma sector may consider companies like Shire (SHPG) and Alkermes (ALKS). Shire carries a Zacks Rank #2 (Buy) while Alkermes holds a Zacks Rank #1 (Strong Buy).