Merck to Continue the Development of Tecemotide in Stage III Non-Small Cell Lung Cancer

Merck has 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, 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 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 EMA on the programme, and has reached an agreement with FDA on a Special Protocol Assessment (SPA) for the Phase III international randomised 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 the Merck Serono division, said: “The START data delivered important insights that we believe justify further investigation in a new Phase III programme. 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.^1,3  

*START: Stimulating Targeted Antigenic Responses To NSCLC

References

1. Agrawal B, et al. Int Immunol 1998;10(12):1907-16.

2. Palmer M, et al. Clin Lung Cancer 2001;3(1):49-57.

3. Sangha R and Butts C. Clin Cancer Res 2007;13:(15 pt 2)4652s-4654s.