Bristol-Myers Squibb's Opdivo nabs MSI-H colorectal cancer nod, but it can't match Keytruda's umbrella approval

Bristol is also expecting an FDA decision on Opdivo in liver cancer later this year.

Bristol-Myers Squibb is facing plenty of doubts about its immuno-oncology ambitions following a major AstraZeneca trial flop last week that raised questions about similar efforts. In the meantime, though, it’s got a new indication for Opdivo that’ll help it vie with Merck’s Keytruda in colorectal cancer.

Tuesday, the New Jersey drugmaker picked up a nod in patients with microsatellite instability-high (MSI-H) metastatic colorectal cancer, a rare tumor type affecting 5% of metastatic colorectal cancer sufferers and making them less likely to respond to conventional chemo, a Bristol spokeswoman said by email.

RELATED: Merck's Keytruda wins first FDA nod to treat genetically ID'd tumors anywhere in the body


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The approval matches a piece of the go-ahead Opdivo’s archrival Keytruda picked up in May. But Keytruda’s green light was wider, covering solid tumors in any part of the body as long as they bear the MSI-H genetic features.

While MSI-H tumorswhich contain abnormalities that affect proper repair of DNA inside cellsare most commonly found in colorectal, endometrial and gastrointestinal cancers, they can also appear in the breast, prostate, bladder, thyroid, and elsewhere, according to the FDA.

RELATED: AstraZeneca's Mystic shortfall is an immuno-oncology shake-up for Bristol-Myers and a bolster for Merck and Roche

Still, the approval is a boost for Bristol following a tough week of lung cancer speculation. Investors have fretted that a failed trial from AstraZenecashowing that its PD-L1/CTLA4 combo of Imfinzi and tremelimumab couldn’t outperform solo Imfinzi or chemo at increasing progression-free survival among first-line lung-cancer patientscould spell similar results for Bristol’s own Opdivo-Yervoy pairing in that setting.

But some analysts, Credit Suisse’s Vamil Divan among them, have encouraged investors to look at Bristol’s broader immuno-oncology picture, which in addition to the MSI-H approval features an upcoming FDA decision on Opdivo in liver cancer as well as data readouts from trials testing the med in kidney cancer, melanoma and more.

Investors naturally have been focused on the lung cancer market and, specifically, how BMY and others will compete in the front-line setting,” Divan wrote to clients last week. But “we would point out that there are numerous other clinical and regulatory catalysts that will likely play out” before Bristol has its Opdivo-Yervoy data in hand “that could impact sentiment” around the company’s shares, he added.

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