MSD’s Keytruda early success ends trial early

pharmafile | October 24, 2016 | News story | Sales and Marketing MSD, Merck, Roche, keytruda, opdivo, tecentriq 

MSD, known as Merck in the US, ended their Phase III trial of Keytruda for treatment of advanced urothelial cancer early having met its primary endpoint, which was to improve overall survival of patients. Keytruda was found to be superior to chemotherapy and the independent Data Monitoring Committee recommended that the trial be stopped early, as a result.

Urothelial carcinoma, the target of the trial, is the most common type of bladder cancer, starting in the urothelial cells that line the inside of the bladder. In 2012 roughly 430,000 people were diagnosed with this type of cancer, with 165,000 dying from the disease.

 “The results of KEYNOTE-045 represent a major breakthrough and will be welcome news for patients dealing with previously treated advanced urothelial cancer,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “We look forward to sharing the findings from this study with the medical community and with regulatory authorities around the world.”

This early success will be a boost in MSD’s battle for the centre ground of immunotherapy treatment. Keytruda is currently being tested in more than 30 tumour types in 360 clinical trials to test its efficacy in treating cancer. It is also being trialled in conjunction with other treatments. Its main competitors are Bristol-Myers Squibb’s Opdivo and the more recent Tecentriq, created by Roche. For the treatment of advanced bladder cancer, Keytruda would be in direct competition with Tecentriq, which was approved for patients of advanced bladder cancer back in May of this year.

The actual results from the trial are expected to be presented at an upcoming medical meeting.

Ben Hargreaves

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