Pfizer, Merck KGaA's Bavencio posts first-in-class bladder cancer win

Pfizer and Merck KGaA’s Bavencio has so far lagged significantly behind its PD-1/PD-L1 classmates, in part because of a series of trial failures. This time, though, it’s turned in a win that could give it a leg up in a crowded market.

In a phase 3 study of bladder cancer patients whose disease hadn’t yet progressed after induction chemo, those randomized to Bavencio lived significantly longer than those who received best supportive care, the companies said Monday. Additional study details will stay under wraps until a future medical meeting, but the drugmakers have already shared them with the FDA and other global regulators.

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The win—in the so-called first-line maintenance setting—is the first of its kind for an immuno-oncology therapy, as Pfizer and Merck KGaA were quick to note. Right now, Bavencio and its biggest rivals—Merck’s Keytruda, Bristol-Myers Squibb’s Opdivo, Roche’s Tecentriq and AstraZeneca’s Imfinzi, are vying for use in other bladder cancer treatment settings.

For Bavencio, the data could lead to earlier use, which tends to mean greater sales as more patients are eligible for therapy. And Pfizer and Merck KGaA will welcome any leg up over their nemeses. With Bavencio, the companies once had a niche without in-class competition, albeit a small one, in Merkel cell carcinoma. But Merck erased that advantage last December with a Merkel cell OK of its own for Keytruda.

The other entry on Bavencio’s short list of indications, aside from bladder cancer and Merkel cell carcinoma? A combo nod in kidney cancer, where it’s fighting both Keytruda and Opdivo—and analysts give the edge there to the Merck behemoth.

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That list pales in comparison to the many indications Bavencio’s rivals have racked up, both in number and market opportunity. But it’s not for lack of trying on the part of the drug’s makers. Bavencio has flunked a series of late-stage studies, most recently missing the mark in stomach cancer, and those flops have prevented it from expanding further.