GlaxoSmithKline sets its sights on a quick leap into the big PD-1/L1 game — will anyone notice?

Somewhat lost in the news last fall that GlaxoSmithKline was buying Tesaro and leaping into the commercial end of the challenging PARP market was a PD-1 checkpoint inhibitor called TSR-042 that was being pointed to a quick filing for endometrial cancer. On Tuesday, the GSK subsidiary spotlighted a promising set of Phase I/II data from their GARNET study, and the filing is on track for later this year as the pharma giant looks to make its own entry into an increasingly crowded field.

Hal Barron

The snapshot for the newly dubbed dostarlimab: Overall response rates in the full population of 125 women with a common form of gynecological cancer — then broken into microsatellite instability-high (MSI-H) and microsatellite stable (MSS) patients — were 30%, 49%, and 20%, respectively. “Disease control rate in the full population, MSI-H population, and MSS population was 53%, 63% and 47%, respectively.”

It’s a small, early study, but the majors in the field have been given the green light for less.

In oncology, any opportunity to use a new drug to help patients is generally avidly welcomed. And GSK’s release notes that there’s only one approved drug for the same setting in endometrial cancer, giving them at least a leg up as rivals like Merck follow up with their own checkpoint combo approaches.

It’s easy, though, to overlook another quick entry on the PD-1/L1 front. There are six approved in the US, two that register mega blockbuster status, a new arrival from Regeneron supported by a research chief known to bring a little fire and brimstone to his leading drug candidates, and several also rans, with Bavencio from Pfizer/Merck KGaA — which is raising eyebrows after a long string of clinical duds. And then there are the multitude of new drugs coming up from behind, and from multiple continents.

Axel Hoos

GSK’s challenge will be to grab attention as a player, with Hal Barron leading the charge and Axel Hoos playing the lead role in cancer. The pharma giant is promising to transform itself into a heavyweight in oncology, after essentially missing out on the cancer revolution that has shaken the industry for the past 5 years. And a PD-1 backbone drug can play a big part.

What’s interesting, though, is how little attention they’re getting for their work. AstraZeneca and Merck rule the PARP roost with Lynparza, growing stronger at seemingly every turn. And Merck’s Keytruda is clearly the dominant drug in the PD-1/L1 crowd.

Playing in the back of this busy field won’t be easy. But no one is counting Barron out.

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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