Monday, July 20, 2015

BMS's Opdivo® Posts A Solid 12 Month Lead, In Metastatic Renal Cell Carcinoma, Over Merck's Keytruda®: Immuno-Oncology Race

This is materially good news for Bristol-Myers. It very-likely gives the Opdivo® franchise yet another high burden cancer in which it will hold a one to two year advantage over Merck's competing Anti-PD L1 candidate. This CheckMate study (one in a series of like-named studies, in other cancers) was stopped early because the advantage was so clear, over existing options.

I would exepct that BMS will file with FDA on this data before year end -- and get clearance for renal cell carcinoma in late Q1 2016. We are seeing the face of oncology transform, and mature, overnight here. This is a $35 billion set of treatments, across all the cancers in which the BMS (and Merck) emerging offerings are likely to be of material benefit. A heady time, indeed. Here's a bit from the presser:

. . . .BMS announced that an open-label, randomized Phase III study evaluating Opdivo (nivolumab) versus everolimus in previously-treated patients with advanced or metastatic renal cell carcinoma (RCC) was stopped early because an assessment conducted by the independent Data Monitoring Committee (DMC) concluded that the study met its endpoint, demonstrating superior overall survival in patients receiving Opdivo compared to the control arm. The company looks forward to sharing these data with health authorities soon.

"The results of CheckMate -025 mark the first time an Immuno-Oncology agent has demonstrated a survival advantage in advanced renal cell carcinoma, a patient group that currently has limited treatment options," said Michael Giordano, senior vice president, Head of Development, Oncology, Bristol-Myers Squibb. "Through our Opdivo clinical development program, we aim to redefine treatment expectations for patients with advanced RCC by providing improved survival. . . ."

We have been following this race for two years solidly, now. The most recent June 2015 background is here. And. . . that's a perfect start, on this hot, moist July Monday -- so. . . onward, friends!

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