Merck Serono To Launch NSCLC Trial

Merck Serono will continue clinical development of the investigational MUC1 antigen-specific cancer immunotherapy tecemotide (also known as L-BLP25 and formerly known as Stimuvax).  

MS, which is developing tecemotide under a license agreement with Oncothyreon, will conduct a new Phase III trial called START2 for patients with unresectable, locally advanced Stage III non-small cell lung cancer (NSCLC). This decision is based on the outcome of the prior START trial. That trial did not meet the primary endpoint of improving overall survival (OS) in the overall patient population, but data from an exploratory analysis of a predefined subgroup of patients who received tecemotide after concurrent chemoradiotherapy (CRT) showed that these patients achieved a median OS of 30.8 months versus 20.6 months in patients treated with placebo.

MS has received Scientific Advice from the EMA on the program and has reached an agreement with the FDA on a Special Protocol Assessment for the trial.

“We are pleased that Merck Serono will be moving forward with the development of tecemotide,” said Robert L. Kirkman, M.D., President and Chief Executive Officer of Oncothyreon. “We believe the data from START support the validity of MUC1 as a target for immunotherapy and are gratified that Merck Serono will seek to confirm the results seen in START in patients receiving concurrent CRT in a new Phase III trial.”