Drug Development

Tom Lynch outlines his comeback strategy for Bristol-Myers’ badly bruised R&D organization

Thomas Lynch

When Tom Lynch took the top R&D job at Bristol-Myers Squibb, he got one of the best — and at the same time, one of the hardest — jobs in biotech.

It was one of the best because Bristol-Myers built what is widely considered one of the most innovative research groups for a biopharma of its size, in a heavyweight class not known for homemade breakthroughs. It was one of the hardest because the group had just derailed, giving up its first-place position in immuno-oncology in a hard fall on a misguided late-stage effort on lung cancer.

That’s how Lynch ended up with the job.

During yesterday’s Q1 call with analysts, Lynch — who made an unusual move from the board to head of R&D — outlined his strategy for what comes next. How can Bristol-Myers retrieve its lead position?

As Lynch noted to a group that included some experienced skeptics, his boardroom position gave him a bird’s eye view of the company’s operations. For a first interview with analysts, he provided an impressive, detailed strategy outline, recognizing the weaknesses in Bristol-Myers’ I/O efforts and offering ways to deal with those weaknesses in the clinic.

Lynch’s game plan centers on the company’s work on next-gen combos, looking to build on Opdivo (PD-1) and Yervoy (CTLA-4) — with all its faults — with new combos and less toxic alternatives now in the clinic.

In Lynch’s words, here’s the strategy:

— (F)irst, accelerating the delivery of our next wave of I-O assets like IDO, which we recently presented data on at AACR. We’ll also be presenting early results for LAG-3, GITR, and the Incyte IDO at ASCO this year.

— Second, understanding the biology of I-O resistance, both intrinsic resistance and acquired, and bringing a laser-like focus to overcoming this. We will focus on expanding into tumor types where I-O hasn’t had a broad impact yet, tumors like breast cancer, colorectal cancer, and prostate cancer. We will use our next-wave assets to create options for patients who progress on their initial I-O therapy.

— Third, we will continue to develop combination regimens, including I-O/I-O combinations, I-O/targeted combinations, and I-O/chemotherapy combinations where these make sense.

— And fourth, we will accelerate the development of our most promising assets in the cardiovascular, immuno-science, and fibrosis pipeline. As [CEO] Giovanni [Caforio] mentioned, we recently presented promising Phase II data on our FGF21 asset in patients with NASH at the International Liver Congress. The results showed an improvement across multiple aspects of NASH, including a significant reduction in liver fat versus placebo.

He followed up by citing an expanded relationship with CytomX to build a less toxic CTLA-4, a move that could eventually have major implications for contenders like AstraZeneca, and all the big rivals currently in the market, from Merck to Roche and Pfizer/Merck KGaA. IDO combinations will play a role here as well.

Geoff Meacham at Barclays observes that it seems that the biggest opportunity is in “cold tumors, breast, ovarian, colon, et cetera. To follow up on the earlier comment, CTLA-4 combos, do you guys feel, at this point, CTLA-4 combos plus a PD-L1 is going to be a component of that?”

Lynch:

So we think we have multiple opportunities to look at combinations of I-O/I-O agents in these cold tumors. We presented data with our IDO asset, as you mentioned, and we also will be presenting initial data at ASCO this year with our GITR compound, which could be the type of agent that might play a role in the cold tumor space.

Tim Anderson at Bernstein also zeroed in on growing questions about the future of PD-1, CTLA-4 combos. “A bear’s point of view could say that this foretells problems with Yervoy and Opdivo, specifically in front-line lung.”

Lynch:

I think the first is that again, just emphasizing how complex and difficult a disease lung cancer is to treat, it’s highly unlikely that there’s going to be one approach that’s going to fit every patient who presents in first-line. We believe strongly that Yervoy/Opdivo is certainly one of the options that needs to be pursued and developed, and we’re looking at that in first-line lung cancer. And we’re also looking at it in the setting of what appropriate biomarkers might be important in evaluating the potential for this combination and for really all of our drugs in first-line lung cancer.

Finally, on new R&D investments:

“(W)e’ve got to execute our pipeline. We’ve got to develop our next-generation drugs. And to do that, we’re going to need to invest in tumor biology and translational medicine as well as data and analytics.”

So there’s the plan. Taking over at R&D now is like jumping on a rolling truck at Bristol-Myers, which spent $5 billion on research last year. You can grab the wheel, but then you have to manage the momentum. That won’t be easy.


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