Merck Serono to continue clinical development of Oncothyreon's tecemotide
SEATTLE—Biotechnology company Oncothyreon Inc. has announced that Merck Serono, the biopharmaceutical division of Merck KGaA, will continue clinical development of tecemotide, also known as L-BLP25 (formerly known as Stimuvax), an investigational MUC1 antigen-specific cancer immunotherapy. Merck Serono is developing the compound under a license agreement with Oncothyreon, and will be conducting a new Phase III trial called START2 for patients with unresectable, locally advanced stage III non-small cell lung cancer.
This announcement builds on a long-term relationship between the two companies. Merck acquired the exclusive worldwide rights to develop and commercialize L-BLP25 from Oncothyreon in 2007, under an agreement that replaced previous collaboration and supply agreements signed in 2001.
START2 will be a multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate tecemotide's efficacy, safety and tolerability in patients with stage IIIA or IIIB non-small cell lung cancer who have had a response or are in a stable disease state after at least two cycles of platinum-based concurrent chemoradiotherapy, which is the current standard of care. The primary endpoint of START2 will be overall survival. Merck Serono has received Scientific Advice from the European Medicines Agency for the program in addition to reaching an agreement with the U.S. Food and Drug Administration with regards to a Special Protocol Assessment for the international trial.
"We are pleased that Merck Serono will be moving forward with the development of tecemotide," Robert L. Kirkman, M.D., president and CEO of Oncothyreon, said in a press release. "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."
In the previous START trial, tecemotide failed to reach its primary endpoint of improving overall survival in the overall patient population, an exploratory analysis of a subgroup of the patients—those who received the compound after concurrent chemoradiotherapy— demonstrated that the patients saw a median overall survival of 30.8 months versus 20.6 months. No new or unexpected safety concerns arose in the START trial, and the most commonly reported adverse effects consisted of nausea, cough, fatigue, flu-like symptoms, dyspnea and reactions at the injection site.
"The results from the START trial provided insights into the potential clinical utility of tecemotide and raised a lot of interest in the scientific community. We haven't seen this type of clinically meaningful survival benefit with any other investigational therapy in unresectable Stage III NSCLC. Further investigation might help to better understand the potential role that tecemotide could play in successfully treating these patients," commented Dr. Charles Butts of the Cross Cancer Institute at the University of Alberta. Butts is a clinical investigator of the START trial as well as a member of the corresponding steering committee.
"The START data delivered important insights that we believe justify further investigation in a new Phase 3 program. NSCLC is a devastating disease, and we are pleased to be able to continue supporting innovation in this important emerging field of immuno-oncology," said Dr. Annalisa Jenkins, head of Global Drug Development and Medical for Merck Serono.
SOURCE: Oncothyreon press release