Luciano Rossetti, Global Head of Research & Development, Merck Serono said, “While the data from the exploratory subgroup analysis in the START trial1 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. Merck Serono remains committed to developing new treatment options for patients with difficult-to-treat cancers.”
The company’s decision to discontinue the current clinical programme in NSCLC, which includes the phase III START2 and INSPIRE studies, follows recent results from a planned analysis of EMR 63325-009, a randomised, double-blind, placebo-controlled phase I/II study in Japanese 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.
Of the patients included in the phase II part of the study, the majority had received concurrent CRT. The results indicate 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). An analysis of the reported adverse events has not identified a clinically meaningful difference in the frequency between treatment groups. Although the trial was not powered to demonstrate a statistically significant difference in benefit between the two arms, Merck Serono made the recommendation to stop the investigational treatment for patients in the EMR 63325-009 study in Japan.
Merck Serono has made the decision to discontinue all other Merck Serono-sponsored clinical trials with tecemotide in NSCLC worldwide. Those 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. The company will continue to supply tecemotide for ongoing investigator-sponsored trials in other indications in accordance with Merck’s agreements with the sponsors of these studies. Merck Serono continues to evaluate a number of investigational compounds for difficult-to-treat cancers, and remains committed to improving the lives of cancer patients and their families.
1. Butts C, et al. Lancet Oncol 2014;15(1):59-68.
EP News Bureau – Mumbai