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MSD's Keytruda misses the mark at Phase 3 in advanced bladder cancer

Published on 11/06/20 at 12:12pm

MSD has announced the disappointing findings that its anti-PD-1 immunotherapy Keytruda (pembrolizumab), when used either alone or combined with chemotherapy, failed to meet its dual goals at Phase 3 in the first-line treatment of advanced or metastatic urothelial carcinoma.

The company revealed that, in a study of 1,010 participants, the Keytruda plus chemo combo was shown to improve overall survival (OS) and progression-free survival (PFS) rates compared to chemo alone – the study’s two main metrics of success – but this was confirmed to not reach statistical significance.  

Furthermore, because the superior efficacy of the Keytruda combo was not reached in OS and PFS, the efficacy of Keytruda as a monotherapy was not formally tested. However, the company noted that the drug’s safety profile was shown to be in line with previous data.

“In this study, Keytruda in combination with chemotherapy in previously untreated patients with advanced or metastatic bladder cancer was rigorously tested against an active control of the current standard of care chemotherapy combination regimen,” explained Dr Roy Baynes, Senior Vice President and Head of Global Clinical Development and Chief Medical Officer at MSD.

“While we are disappointed in these study results, Keytruda has been established as an important option in the treatment of metastatic bladder cancer, and we are committed to continuing our research to help more patients with this disease. We are grateful to the patients and investigators for their participation in this study.”

While this particular study may have flopped, Keytruda has already secured three bladder cancer approvals in varying indications form the FDA. MSD also confirmed that the full data from the study would be presented at an upcoming medical conference and discussed with regulatory authorities.  

Matt Fellows

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