Merck Serono continues the development of tecemotide (L-BLP25) in stage III non-small cell lung cancer

• The program will build upon the data from START trial and explore potential in patients with Stage III NSCLC who have demonstrated stable disease or objective response after concurrent chemoradiotherapy

• The Phase III START2 study will be conducted under a Special Protocol Assessment (SPA) with FDA

Merck Serono, the biopharmaceutical division of Merck, today announced the decision to continue clinical development of its investigational MUC1 antigen-specific cancer immunotherapy tecemotide (also known as L-BLP25) under a new Phase III trial called START2 for patients with unresectable, locally advanced Stage III non-small cell lung cancer (NSCLC).

This announcement is based on the outcome of the START trial. The START trial did not meet the primary endpoint of improving overall survival (OS) in the overall patient population. Data from an exploratory analysis of a predefined subgroup of patients in the START trial, 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 (n=806; HR: 0.78; 95% CI 0.64–0.95; p=0.016).

Concurrent CRT is a combination of chemotherapy and radiotherapy given at the same time.

The START2 trial is a Phase III, multicenter, randomized, double-blind, placebocontrolled 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 CRT. Concurrent CRT is the current standard of care for these patients.

The trial’s primary endpoint is OS. The company also announced that it has received Scientific Advice from the European Medicines Agency (EMA) on the
program, and has reached an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the Phase III international randomized trial.

“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 therapies in unresectable Stage III NSCLC. Further investigation might help to better understand the potential role that tecemotide could play in successfully treating these patients,” said Dr. Charles Butts, Cross Cancer Institute, University of Alberta, Edmonton, Canada, clinical investigator of the START trial and member of the corresponding steering committee.

Dr. Annalisa Jenkins, Head of Global Drug Development and Medical for Merck Serono, said: “The START data delivered important insights that we believe justify further investigation in a new Phase III 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.”

Tecemotide is an investigational MUC1 antigen-specific cancer immunotherapy designed to stimulate the body’s immune system to identify and target cancer cells expressing the cell-surface glycoprotein MUC1.1,2 MUC1 is expressed in many cancers, including NSCLC, and has multiple roles in tumor growth and survival.

Globally, lung cancer is the most common cause of cancer-related deaths in men and the second most common in women, responsible for almost twice as many deaths as both breast and prostate cancer combined.

NSCLC is the most common type of lung cancer, accounting for 80–85% of all lung cancers, and locally advanced or Stage III disease accounts for approximately 30% of patients with NSCLC.5,6

Source: Merck Serono