Merck Serono has stopped 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).
Tecemotide was being evaluated in the Phase III START2, START and INSPIRE trials to treat unresectable, locally advanced Stage III NSCLC.
In 2007, the company secured the exclusive worldwide rights for development and commercialisation of tecemotide from Oncothyreon, in an agreement replacing prior collaboration and supply agreements originally entered in 2001.
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."
The decision to discontinue the clinical trials follows recent results from a planned analysis of EMR 63325-009 in Japanese patients.
The randomised, double-blind, placebo-controlled Phase I/II EMR 63325-009 trial was carried out in patients who had received concurrent or sequential chemoradiotherapy (CRT), with a minimum of two cycles of platinum-based chemotherapy and radiation dose =50 Gy.
Majority of the patients included in the Phase II trial had received concurrent CRT.
Results show that no effect has been observed for either the primary endpoint, overall survival (OS), or for any of the secondary endpoints (progression-free survival [PFS], time to progression [TTP] and time to treatment failure).
According to the company, patients on active treatment with tecemotide can undergo an individual assessment by their treating physician and apply to receive further treatment outside of the studies.
Merck Serono will continue to supply tecemotide for the ongoing investigator-sponsored trials in other indications in accordance with Merck's agreements with the sponsors of these studies.