) announced that
) 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
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
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
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
Oncothyreon carries a Zacks Rank #3 (Hold). Companies which
look attractive include
), each with a Zacks Rank #1 (Strong Buy).
AFFYMETRIX INC (AFFX): Free Stock Analysis
ACTELION LTD (ALIOF): Get Free Report
MERCK KGAA (MKGAF): Get Free Report
ONCOTHYREON INC (ONTY): Free Stock Analysis
To read this article on Zacks.com click here.