publication date: Oct. 1, 2014

Merck Serono Cancels Tecemotide Program In NSCLC, Including Two Phase III Trials

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Merck Serono will discontinue its worldwide clinical development program of MUC1 antigen-specific immunotherapy tecemotide as a monotherapy in stage III non-small cell lung cancer. This includes the phase III START2 and INSPIRE studies.

The decision comes after a planned analysis of EMR 63325-009, a randomized, double-blind, placebo-controlled phase I/II study in Japanese patients with stage III unresectable, locally advanced NSCLC. Patients had received concurrent or sequential chemoradiotherapy with a minimum of two cycles of platinum-based chemotherapy and radiation dose greater than or equal to 50 Gy.

Of the patients included in the phase II part of the study, the majority had received concurrent CRT. No effect has been observed for either the primary endpoint of overall survival, or for any of the secondary endpoints, including progression-free survival, time to progression, 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.

“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,” said Luciano Rossetti, global head of research and development at Merck Serono.

The START2 study is a 1:1 randomized, double-blind, placebo-controlled clinical trial in unresectable, stage IIIA or IIIB NSCLC who have had a response or stable disease after at least two … Continue reading CCL Sept – NSCLC

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