Immuno-oncology, Results

Merck previews an early hit with Keytruda combo for kidney cancer, putting more pressure on rival Bristol-Myers

Merck arrived at ESMO in style, fronting their appearance in Munich with positive — and very early — combination data for their PD-1 checkpoint star Keytruda in treating frontline kidney cancer.

Researchers combined Keytruda with Pfizer’s Inlyta for KEYNOTE-426 and came away with an early win on both progression-free and overall survival, along with a key secondary in beating Sutent in a head-to-head showdown.

The hard data will come later at another conference, but the FDA gets to see it first as Merck hustles for yet another supplemental approval for its franchise player.

Merck’s team called this a win at a very early point, catching analysts like Evercore ISI’s Umer Raffat by surprise. The final data weren’t expected before the 2019/20 time frame. But Merck has been pulling out all stops in its successful quest to push ahead of Bristol-Myers Squibb, who now faces fresh competition on this front as well for its combination of Opdivo-Yervoy.

Bristol-Myers won an OK for first line kidney cancer earlier in the year. But then the CHMP in Europe turned thumbs down, saying the company had not “demonstrated the contribution of components sufficiently well.” Bristol-Myers is appealing while Merck looks to cut ahead of the line yet again.

“This marks the first time that combination treatment with an anti-PD-1 therapy has achieved the dual primary endpoints of overall survival and progression-free survival as first-line therapy in advanced renal cell carcinoma,” said Merck R&D chief Roger Perlmutter, who’s been overseeing a grid of hundreds of studies for their PD-1. “Fewer than 10 percent of those diagnosed with advanced renal cell carcinoma survive for five years, and hence there is significant need for improved therapies for this disease.”

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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Catalytic Data Science Charleston, SC
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Flatiron Health New York City or San Francisco

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