Bristol-Myers Squibb: It's all about the 'breakthrough' drug nivolumab now

Bristol-Myers ($BMY) has one of the best drug development track records in the industry, and the big biotech is devoting major resources to its immuno-oncology lead. Bristol-Myers issued 5 new releases on nivolumab last night, and they all followed an early-morning statement on a new nivo combo study being mounted with Celldex.

The FDA helped make Bristol-Myers' case for the PD-1 drug by giving nivolumab breakthrough status for Hodgkin's lymphoma after failure of autologous stem cell transplant and brentuximab. But the analysts were hungry for more data, not bragging rights to a drug they had assigned blockbuster expectations to long ago.

They got a taste of that with promising results for nivolumab combined with Yervoy in previously treated renal cancer.

"In the Phase Ib CheckMate-016 trial, which evaluated the safety and tolerability of nivolumab at different doses and schedules as part of a regimen with other agents, (the overall response rate) for the investigational combination regimen of nivolumab and Yervoy (ipilimumab) ranged from 43-48% with a 24-week progression free survival rate that ranged from 64-65% in previously treated and treatment-naïve patients," Bristol reported.

"These data are quite good, but perhaps not as 'mind blowing' as the combo data were in melanoma at last year's ASCO," says ISI's Mark Schoenebaum.

Schoenebaum was more enthusiastic about nivo plus chemo in first-line lung cancer. "The one-year landmark (overall survival rates) in the abstract are stellar at 59%-87% (depending on chemo regimen and histology) which is above what you would expect historically (historical rates are 40%-50%)." But with serious signs of toxicity and a muted response among patients, expectations of Yervoy plus nivolumab in first-line lung cancer are plunging.

That's the point that a lot of investors seized on Thursday morning, particularly after BMO Capital downgraded the stock after considerable speculation regarding the potential of Yervoy and nivo in lung cancer. Shares of Bristol-Myers slid 6% this morning.

There's plenty more coming up on nivolumab at ASCO, so stay tuned.

- here's the release from Bristol-Myers on the renal cell results
- here's the release on lung cancer

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