Bristol-Myers Squibb, leading immuno-oncology in liver cancer, nabs Opdivo 'priority' tag and nears Bayer showdown

Opdivo
If Bristol-Myers Squibb's Opdivo can win an FDA approval in second-line liver cancer, it'll take on Bayer's Stivarga.

When it comes to the immuno-oncology rivalry between Merck’s Keytruda and Bristol-Myers Squibb’s Opdivo, Keytruda has lately been running the table. But Wednesday, Opdivo snagged priority review in liver cancer—a field where it would face a different rival.

U.S. regulators granted Bristol a speedy review of its med in patients with hepatocellular carcinoma—the most common type of liver cancer—who've already been treated with Bayer’s Nexavar. It’s no small population; more than 40,000 U.S. patients are diagnosed with the disease each year, the company said.

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Bristol-Myers is the first to win that designation in HCC, though a couple of its immuno-oncology rivals are working through their own programs in that arena. At the annual American Society of Clinical Oncology meeting next month, AstraZeneca will present a phase 1/2 study of its PD-L1 checkpoint inhibitor med Imfinzi and new candidate tremelimumab, in patients with HCC that's not appropriate for surgery.

Meanwhile, Merck has several studies in the works evaluating Keytruda in HCC, both on its own and in tandem with other meds. A trial examining the PD-1 med as a second-line treatment post-Nexavar hasn't yet begun recruiting, according to ClinicalTrials.gov.

The liver-cancer designation would give Bristol-Myers a chance to pick up some ground after a rough stretch for Opdivo. The med has ceded its non-small cell lung cancer lead to Keytruda, which now boasts both monotherapy and combo approvals in previously untreated patients, the largest group. Merck, meanwhile, has been rubbing salt in BMS’ wounds, this month scoring three FDA approvals and a priority review of its own.

RELATED: With Stivarga-Nexavar bridge-building complete in liver cancer, Bayer gets ready to run the table

If Opdivo does eventually score a go-ahead, though, it’ll have some non-checkpoint competition to worry about in Bayer’s Stivarga. The German pharma netted an HCC nod for the med just last month, creating what the company perceived as a bridge between the older Nexavar and newer Stivarga.

And despite the immuno-oncology wave taking the cancer world by storm, Bayer isn’t intimidated by the competition.

“We know that there are other drugs being studied in this area, but those would be one-off approvals—front line, second line—but not necessarily this continuum approach that we could actually offer physicians as they think about the totality of treatments for the patients,” company oncology head Robert LaCaze told FiercePharma in an interview late last year.