Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Merck Serono has discontinued all remaining clinical studies of its investigational MUC1 antigen-specific cancer immunotherapy tecemotide (L-BLP25) as a monotherapy in Stage III non-small cell lung cancer (NSCLC).
Subscribe to our email newsletter
Tecemotide was being assessed in the Phase III START2, START and INSPIRE trials to treat unresectable, locally advanced Stage III NSCLC.
In 2007, the company received the exclusive worldwide rights to develop and commercialize tecemotide from Oncothyreon.
Merck Serono global head of research and development Luciano Rossetti said while the data from the exploratory subgroup analysis in the START trial generated a reasonable hypothesis to warrant additional study, the results of the recent trial in Japanese patients decreased the probability of current studies to reach their goals.
"Therefore, we have decided to discontinue the development of tecemotide as a monotherapy in NSCLC in order to refocus our efforts on other promising candidates in our pipeline, like our anti-PD-L1 antibody MSB0010718C," Rossetti said.
"We remain committed to developing new treatment options for patients with difficult-to-treat cancers."
The decision to discontinue the clinical trials follows recent results from a planned analysis of Phase I/II EMR 63325-009 trial in Japanese patients.
The randomized, double-blind, placebo-controlled Phase I/II trial was carried out in patients with Stage III unresectable, locally advanced NSCLC who had received concurrent or sequential chemoradiotherapy (CRT), with a minimum of two cycles of platinum-based chemotherapy and radiation dose =50 Gy.
Merck Serono will continue to supply tecemotide for ongoing investigator-sponsored trials in other indications in accordance with Merck’s agreements with the sponsors of these trials.