Pfizer, Merck KGaA hit the brakes on another PhIII as PD-L1 Bavencio flops yet again

Pfizer and Merck KGaA are cementing in their distant runner-up status for Bavencio (avelumab), a PD-L1 checkpoint that just failed its fourth late-stage trial. And the drumbeat of setbacks — at a time checkpoints are proliferating around the world — will hurt their prospects for making this the blockbuster they both need.

This time around researchers simply said that Bavencio in combination with or following chemo in frontline ovarian cancer cases had failed the primary endpoint on progression-free survival, forcing them to draw a halt to the work.

The drug also failed the Ovarian 200 study a month ago, testing Bavencio in patients with drug-resistant cases. That followed a flop for second-line lung cancer as well as an earlier setback on gastric cancer.

The latest failure follows a series of steady advances at Merck, which has come out of a round of chemo-combo studies as the clear leader in the megablockbuster PD-1/L1 checkpoint market. Just two days ago the FDA offered Keytruda another add-on approval for Merkel cell carcinoma. Bristol-Myers Squibb has fallen behind but still is a contender.

Altogether 6 checkpoints have reached approval in the US, and a seventh just got an OK in China, where dozens of additional checkpoints are in development. Gaining a rep for failure in cancer studies, after winning an OK for Merkel cell carcinoma and advanced bladder cancer, could seriously damage the Pfizer/Merck KGaA team’s prospects in an increasingly crowded field of rivals.

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VP Oncology Biology
Skyhawk Therapeutics Waltham, MA
Director Process Development
Elektroki Boston, MA
Director Process Development
Elektroki Boston, MA
Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT

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