ASCO: Pfizer, Merck KGaA's Bavencio lines up for bladder cancer edge with survival win

In a bladder cancer field chock-full of checkpoint inhibitors, Pfizer and Merck KGaA’s Bavencio has a chance to get ahead thanks to new data in post-chemo patients.

In a phase 3 study, Bavencio (avelumab) extended patients’ lives by a median 21.4 months, compared with 14.3 months for best supportive care—marking an improvement of more than seven months, data released ahead of the American Society of Clinical Oncology’s (ASCO's) virtual annual meeting showed.

And in patients whose tumors tested positive for biomarker PD-L1, Bavencio significantly prolonged lives, too; median overall survival for patients on the drug hadn’t been reached at the time of the check-in.

"The strength of the data in all-comers as well as PD-L1+ patients suggest that Bavencio first-line maintenance treatment has the potential to be practice-changing in this setting and represents a potential game-changer for metastatic bladder cancer patients," Andy Schmeltz, global president and general manager of Pfizer's oncology unit, said in a statement.

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The win is a big one for Bavencio, as it marks the first of its kind for an immuno-oncology drug. While several members of Bavencio’s PD-1/L1 class are competing for share in later stages of bladder cancer, Pfizer and Merck KGaA’s contender would be the only one with a first-line maintenance approval if the data can secure it an FDA green light.

And Bavencio could use a niche of its own. While it entered the scene with a Merkel cell carcinoma nod, Merck’s Keytruda has since gone on to snag one of its own in that disease. And aside from metastatic bladder cancer, Bavencio's other treatment area is also a crowded one: kidney cancer, where both Keytruda and Bristol Myers Squibb’s Opdivo are facing it down.

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That indication list might be longer if it hadn’t been for a series of trial flops in areas including head and neck cancer and stomach cancer. But the bladder cancer data wasn’t the only Bavencio highlight for Pfizer and Merck KGaA Thursday: The drug also showed it could help prevent relapse in women with gestational trophoblastic tumors.