Merck Serono Initiates Tecemotide Phase 3 Trial In NSCLC

Merck biopharmaceutical division Merck Serono announced the launch of the Phase III START2 study evaluating the efficacy and safety of tecemotide (L-BLP25) in patients with unresectable, locally advanced Stage III non-small cell lung cancer (NSCLC).

START2 (Stimulating Targeted Antigenic Responses To NSCLC) is an international multi-center, randomized, double-blind, and placebo controlled study expected to involve about 1,000 patients suffering from unresectable, locally advanced (Stage IIIA or IIIB) NSCLC who have had responded to or had stable disease after at least two cycles of platinum-based concurrent chemoradiotherapy (CRT). START2’s primary endpoint is overall survival, while secondary endpoints include time to symptom progression, progression free survival, and time to progression.

Dr. John Orloff, global head of clinical development for Merck Serono, said, “There is clearly a very real need for additional treatment options for people fighting NSCLC. The results of the initial START study provided scientific and clinical evidence to inform the design of this new pivotal Phase 3 program. We are pleased that START2 is now underway, and feel confident that this study will address the appropriate gaps in understanding the potential role that tecemotide could play in the management of patients living with unresectable Stage III NSCLC.”

Lung cancer is the leading cause of cancer deaths in men and the third leading cause in women. Non-small cell lung cancer is the most common type of the disease, responsible for about 80 percent to 85 percent of all lung cancers. Of these, Stage III disease accounts for an estimated 30 percent of patients with NSCLC.

Tecemotide is an investigational MUC1 antigen-specific cancer immunotherapy that works to induce the immune system to target cancer cells expressing MUCI, a cell-surface glycoprotein. MUCI is expressed in NSCLC as well as other cancers, and plays several roles in tumor growth and survival.

The company said it received scientific advice from the European Medicines Agency (EMA) on the study and has reached an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for START2.