Merck Serono Decides To Continue Development Of Tecemotide In Stage III NSCLC

(RTTNews) - Oncothyreon Inc. (ONTY) announced Wednesday that Merck Serono, the biopharmaceutical division of German drugmaker Merck KGaA (MKGAY.PK), has decided to continue clinical development of the investigational MUC1 antigen-specific cancer immunotherapy tecemotide (also known as L-BLP25 and formerly known as Stimuvax).

Oncothyreon noted that Merck Serono will conduct a new Phase 3 trial called START2 for patients with unresectable, locally advanced Stage III non-small cell lung cancer or NSCLC. Merck Serono is developing tecemotide under a license agreement with Oncothyreon,

This decision is based on the outcome of the prior START trial. While the START trial did not meet the primary endpoint of improving overall survival or OS in the overall patient population, data from an exploratory analysis of a predefined subgroup of patients, who received tecemotide after concurrent chemoradiotherapy or CRT, showed that these patients achieved a median OS of 30.8 months versus 20.6 months in patients treated with placebo (n=806; HR: 0.78; 95% CI 0.64-0.95; p=0.016).

Concurrent CRT is a combination of chemotherapy and radiotherapy given at the same time.

START2 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial designed to assess the efficacy, safety and tolerability of tecemotide in patients with unresectable, locally advanced (Stage IIIA or IIIB) NSCLC who have had a response or stable disease after at least two cycles of platinum-based concurrent CRT. Concurrent CRT is the current standard of care for these patients. The trial's primary endpoint is OS.

Merck Serono also announced that it received Scientific Advice from the European Medicines Agency or EMA on the program and has reached an agreement with the U.S. Food and Drug Administration or FDA on a Special Protocol Assessment or SPA for the Phase 3 international randomized trial.