Merck to continue lung cancer vaccine development

Merck KGaA has decided to continue clinical development of its non-small cell lung cancer drug tecemotide.

Tecemotide, an investigational MUC1 anitgen-specific cancer immunotherapy, will be evaluated in a new phase 3 clinical trial called START2 for patients with unresectable, locally advanced Stage III non-small cell lung cancer (NSCLC).

Merck’s decision is based on the outcome of tecemotide in the START trial, as the drug did not meet the primary endpoint of improving overall survival (OS) in the overall patient population.

Merck has received Scientific Advice from the European Medicines Agency (EMA) on the clinical program, and has reached an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the phase 3 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.”

Dr. Charles Butts, Cross Cancer Institute, University of Alberta, Edmonton, Canada, clinical investigator of the START trial and member of the corresponding steering committee.

“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.”

Dr. Annalisa Jenkins, Head of Global Drug Development and Medical for the Merck Serono division.

Lung cancer is the most common cause of cancer-related deaths in men, and the second most common in women, worldwide. NSCLC is the most common type of lung cancer, accounting for 80 – 85% of all lung cancers.

 

 

Related news:

Merck KGaA revives testing of cancer vaccine (Reuters)

Reference links:

Merck KGaA press release

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