Pfizer defends kidney-cancer position with Bavencio 'breakthrough'

The breakthrough designation is the second for Merck KGaA and Pfizer's Bavencio.

Pfizer has long expected immuno-oncology rivals to push aside its kidney cancer blockbuster, Sutent. But now, it’s getting in on the action with its own I-O product.

The FDA has bestowed its breakthrough designation on a combination of Bavencio—the PD-L1 cancer-fighter Pfizer shares with Merck KGaA—and its Sutent follow-up drug, Inlyta, in previously untreated renal cell carcinoma patients. The tag promises a speedy review of the pair.

RELATED: Bristol-Myers Squibb could double patient numbers for Opdivo in kidney cancer

It’s good news for Pfizer, which has already watched two other I-O meds top Sutent, the standard of care, in trials. In September, Bristol-Myers Squibb said that in a first-line trial, its Opdivo-Yervoy tandem had delivered a 32% reduction in the risk of death compared with Sutent. Among intermediate- and poor-risk patients, that number jumped to 37%.

More recently, Roche touted top-line data from a phase 3 study showing that a combination of PD-L1 therapy Tecentriq and anti-VEGF antibody Avastin could beat out Sutent at cutting the risk of patients' disease worsening or death by a "statistically significant and clinically meaningful" margin among patients whose tumors expressed PD-L1.

RELATED: Pfizer’s Sutent kidney cancer win should give it a boost, at least until I-O treatments arrive

Pfizer and Merck KGaA, for their parts, are still working through a phase 3 Bavencio-Inlyta trial, which should wrap up by the end of this year; the breakthrough boost comes based on phase 1b results, Pfizer said. The New York pharma giant, though, is expecting a strong performance.

“Pfizer’s expertise in developing treatments for advanced RCC is a distinct advantage in tackling this tumor type,” Chris Boshoff, SVP and head of Immuno-Oncology, Early Development and Translational Oncology, Pfizer Global Product Development, said in a statement.

RELATED: FDA puts Bristol-Myers' Opdivo-Yervoy combo in fast lane for new kidney cancer nod

For now, Sutent’s first-line patient pool is still intact. Opdivo is currently the only PD-1/PD-L1 contender approved in the disease at all, but it’s only indicated for previously treated patients. That could soon change, though: Last month, the FDA granted priority review status to Bristol’s Opdivo-Yervoy pairing.