Oncothyreon : Merck KGaA Initiates Phase 3 START2 Study With Tecemotide

(RTTNews) - Oncothyreon Inc. (ONTY) announced that German drug maker Merck KGaA (MKGAY.PK) has initiated the international Phase 3 START2 study, which is designed to assess the efficacy and safety of the investigational MUC1 antigen-specific cancer immunotherapy tecemotide (also known as L-BLP25) in patients with unresectable, locally advanced Stage III non-small cell lung cancer or NSCLC. Merck KGaA, Darmstadt, Germany, is developing tecemotide under a license agreement with Oncothyreon.

The START2 study is a Phase 3, multicenter, 1:1 randomized, double-blind, placebo-controlled clinical trial designed to assess the efficacy, safety and tolerability of tecemotide in patients suffering from 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 chemoradiotherapy or CRT.

Concurrent CRT - a combination of chemotherapy and radiotherapy given at the same time - is the current standard of care for most of these patients. The study is expected to recruit approximately 1,000 patients.

The primary endpoint is overall survival or OS. Secondary endpoints include time to symptom progression, progression-free survival and time to progression.

Merck KGaA, Darmstadt, Germany received Scientific Advice from the European Medicines Agency (EMA) on the program and reached an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the trial.

START2 is based on the outcome of the prior START trial. While the START trial did not meet the primary endpoint of improving OS in the overall patient population, data from an exploratory analysis of a predefined subgroup of patients, who received tecemotide after concurrent 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).