The FDA approved the use of Opdivo with Yervoy in front-line colorectal cancer, while a Manhattan court junked a class action complaint over the blood cancer drug Pomalyst.
Tuesday was a good day for Bristol Myers Squibb, with the pharma notching two key cancer wins—one with the FDA and another in the courtroom.
The regulator cleared the combination of the PD-1 blocker Opdivo and the anti-CTLA4 antibody Yervoy as a first-line treatment for patients with unresectable or metastatic colorectal cancer (CRC). The FDA’s approval covers patients carrying the specific genetic profiles, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).
The FDA’s decision was supported by data from the CheckMate-8HW study. Compared with Opdivo monotherapy, the combo regimen cut the risk of disease progression or death by 38%, a statistically significant benefit, as per a January news release. An earlier readout in January 2024 found that Opdivo plus Yervoy improved progression-free survival (PFS) by 79% versus the investigators’ choice of chemotherapy.
BMS’ combo regimen demonstrated its PFS benefit quickly, separating from Opdivo monotherapy as early as two months into treatment, which was sustained through three years. Opdivo plus Yervoy also resulted in a significantly higher overall response rate, a key secondary measure, versus Opdivo alone.
With Tuesday’s regulatory win, Opdivo now has nine approved indications in the gastrointestinal space, Wendy Short Bartie, senior vice president of Oncology Commercialization at BMS, said in a statement. She called the approval a “milestone,” opening up “an important new approach in the first-line setting” for patients with MSI-H/dMRR CRC, who continue to “face high unmet need.”
BMS is continuing to develop its Opdivo-Yervoy combo. The pharma has proposed the regimen for the first-line treatment of unresectable hepatocellular carcinoma in a supplemental Biologics License Application (sBLA), for which the FDA is expected to release its decision by April 21.
Also on Tuesday, BMS notched a key legal win with a Manhattan judge dismissing a proposed class action suit alleging that the pharma illegally maintained the monopoly of its multiple myeloma drug Pomalyst by obtaining fraudulent patents and aggressively suing generics developers.
According to reporting from Reuters, U.S. District Judge Edgardo Ramos found that the plaintiffs—Pomalyst purchasers led by Blue Cross Blue Shield of Louisiana—failed to sufficiently back their claim that BMS had committed fraud in securing certain patents for the drug. The plaintiffs were also unable to show that BMS’s lawsuits—through its subsidiary Celgene—against developers of generic drugs were baseless.
Pomalyst is an oral thalidomide analog approved in 2013 to treat patients with multiple myeloma who have undergone at least two prior lines of therapies. Despite being on the market for more than a decade, the drug’s revenue continued to grow in 2024, with worldwide sales rising 3% year-on-year to $3.5 billion.
