(Corrects reason why some patients benefited in sixth paragraph.)
Sept. 25 (Bloomberg) -- Merck KGaA will pursue research on a therapeutic cancer vaccine that failed in a clinical trial to find out whether the treatment works better in a specific group of advanced lung cancer patients.
Merck will start a new late-stage trial for the vaccine known as tecemotide with the goal of extending overall survival, the Darmstadt, Germany-based drugmaker said today in a statement. The company said in December that the drug failed to improve survival significantly in a trial dubbed Start of more than 1,200 patients.
The product, also called L-BLP25, is designed to stimulate a patient’s immune system to identify and target cancer cells with the MUC1 gene, which has an effect on tumor growth and survival. Non-small cell lung cancer is the most common form of the disease and most people diagnosed with it are at an advanced stage, the company said.
“The START data delivered important insights that we believe justify further investigation in a new Phase III program,” Annalisa Jenkins, head of global drug development and medical for the Merck Serono division, said in the statement.
The European Medicines Agency and the U.S. Food and Drug Administration gave Merck advice on the new trial, which is called START2, the company said.
A group of 806 patients who received the vaccine following a combination of chemotherapy and radiotherapy survived an average of 10 months longer than those who received the placebo, Merck said May 16. The company believes these patients responded better to the treatment, which was formerly known as Stimuvax, because they received chemotherapy and radiation at the same time while the others received the standard of care consecutively before receiving either tecemotide or placebo.
Merck licensed the drug in 2001 from Oncothyreon Inc. and agreed to pay its Seattle-based partner $90 million, plus royalties on sales if the vaccine made it to market.
The decision comes two months after Merck established an immuno-oncology platform to develop cancer vaccines, stem cell therapies and immunotherapies. While most analysts don’t have sales estimates for L-BLP25 because it was considered high-risk, Merck is developing other therapies aimed at teaching the immune system to fight cancer, including NHS-IL2 for solid tumors.
Merck continues testing tecemotide in 425 patients in a trial in Asia called Inspire.
Merck said Jan. 6 that it would refocus research on the core areas of cancer, immune disorders, multiple sclerosis and fertility treatments following several drug development setbacks and a management shuffle.
--Editors: Phil Serafino, Tim Farrand