Hot on the heels of its Bristol-Myers slapdown, Merck scores PhIII bladder cancer success with Keytruda

Merck is taking another step forward in its campaign to expand the blockbuster market for its checkpoint inhibitor Keytruda. The pharma giant, only recently handed the edge in lung cancer after a devastating setback at Bristol-Myers Squibb, says its Phase III for bladder cancer hit the primary endpoint during a preliminary evaluation.

Merck will now wrap the study early and hustle to the FDA, looking to challenge Roche, which landed a landmark approval for its checkpoint rival Tecentriq for bladder cancer back in May. Keytruda was tested in treatment-resistant patients following platinum-based chemo. The control arm included investigators’ choice of chemo.

Merck, Roche and Bristol-Myers Squibb have all mounted extensive pipeline efforts to take their pioneering checkpoints into multiple cancer markets. And AstraZeneca as well as Pfizer/Merck KGaA hope to follow relatively soon with their own development strategies in play.

Merck now has 360 clinical trials underway involving Keytruda, including more than 200 combination studies. That by itself would easily eclipse all but the biggest pipelines in the industry. And the positive early score in bladder cancer follows news two days ago that its late-stage candidate letermovir succeeded in a lengthy Phase III in preventing CMV infections.

“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.”

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