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 lungcancer who have had a response or are in a stable disease state after at leasttwo cycles of platinum-based concurrent chemoradiotherapy, which is the currentstandard of care. The primary endpoint of START2 will be overall survival.Merck Serono has received Scientific Advice from the
European Medicines Agencyfor the program in addition to reaching an agreement with the
U.S. Food andDrug Administration with regards to a Special Protocol Assessment for theinternational trial.
"We are pleased that Merck Serono will be moving forwardwith the development of tecemotide," Robert L. Kirkman, M.D., president and CEOof Oncothyreon, said in a press release. "We believe the data from STARTsupport the validity of MUC1 as a target for immunotherapy and are gratifiedthat Merck Serono will seek to confirm the results seen in START in patientsreceiving concurrent CRT in a new Phase III trial."
In the previous START trial, tecemotide failed to reach itsprimary endpoint of improving overall survival in the overall patientpopulation, an exploratory analysis of a subgroup of the patients—those whoreceived the compound after concurrent chemoradiotherapy—demonstrated that thepatients saw a median overall survival of 30.8 months versus 20.6 months. Nonew or unexpected safety concerns arose in the START trial, and the mostcommonly reported adverse effects consisted of nausea, cough, fatigue, flu-likesymptoms, dyspnea and reactions at the injection site.
"The results from the START trial provided insights into thepotential clinical utility of tecemotide and raised a lot of interest in thescientific community. We haven't seen this type of clinically meaningfulsurvival benefit with any other investigational therapy in unresectable StageIII NSCLC. Further investigation might help to better understand the potentialrole that tecemotide could play in successfully treating these patients,"commented Dr. Charles Butts of the Cross Cancer Institute at the
University ofAlberta. Butts is a clinical investigator of the START trial as well as amember of the corresponding steering committee.
"The START data delivered important insights that we believejustify further investigation in a new Phase 3 program. NSCLC is a devastatingdisease, and we are pleased to be able to continue supporting innovation inthis important emerging field of immuno-oncology," said Dr. Annalisa Jenkins,head of Global Drug Development and Medical for Merck Serono.
SOURCE: Oncothyreon press release
