#ESMO17: Bristol-Myers posts data on an upset checkpoint combo victory in frontline kidney cancer

Madrid — There may be five PD-(L)1 drugs on the market, but they’re still continuing to produce surprising results in clinical trials.

The latest upset is a win for Bristol-Myers Squibb. After failing to hit its marks on progression-free survival, a combination of Opdivo and Yervoy reduced the risk of death by 37% compared to Pfizer’s standard-of-care sunitinib among intermediate- and poor-risk kidney cancer patients. The combo also kicked in with an improved overall survival rate — not yet fully determined — according to the latest data for CHECKMATE-214 released at ESMO on Sunday.

Two other key points: There was a 42% objective response rate among patients, with 9.4% complete responses. And the combo — matching a PD-1 and CTLA-A — had a lower rate of serious adverse events; 46% for the combo compared to 64% in the sunitinib arm.

More patients in the combination arm, though, had to discontinue therapy due to adverse events: 22% compared with 12% for sunitinib. Yervoy and the entire CTLA-4 class is linked with a high rate of toxicity that has long concerned analysts covering the field.

Bristol-Myers’ execs say the data should highlight another upcoming change in the standard of care for frontline cancer therapy.

The update from Bristol-Myers marks the latest in a complex set of twists and turns for Bristol-Myers Squibb, as all of the companies in the space race for the lead position in various cancer types.

The news today — which followed a decision to stop the study early so that everyone in the trial could get the combo — also underscores another big question in checkpoint R&D. After AstraZeneca’s PD-L1/CTLA-4 also flopped on progression-free survival, there may be considerably more hope that their combo could succeed on overall survival, which is the most important endpoint. That won’t be determined, though, until H1 2018.

“There is an unmet need for additional treatment options in the first line setting that may provide a meaningful survival benefit including more durable, complete responses for patients with advanced renal cell carcinoma. These results for the combination of nivolumab and ipilimumab are very encouraging in patients with first-line mRCC who have a very poor prognosis,” said Bernard Escudier, former chair of the genitourinary group of the Institut Gustave Roussy in Villejuif, France.

Image credit: ESMO

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