Bristol Myers Squibb (NYSE: BMY) announced today that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) as a potential first-line treatment for adults with unresectable hepatocellular carcinoma (HCC). This application is supported by the results from the Phase 3 CheckMate -9DW trial. The FDA has set a Prescription Drug User Fee Act (PDUFA) target date of April 21, 2025.
“HCC, the most prevalent form of liver cancer, is frequently diagnosed at a stage when surgery is no longer viable. With a growing number of HCC cases in the United States over the past decade, there is a pressing need for new treatment options,” stated Dana Walker, M.D., M.S.C.E., vice president, global program lead for gastrointestinal and genitourinary cancers at Bristol Myers Squibb. “Opdivo combined with Yervoy has demonstrated superior survival benefits compared to existing treatments, and we are eager to collaborate with the FDA to potentially offer a new first-line treatment option for patients.”
The sBLA submission is based on data from the Phase 3 CheckMate -9DW study, where the Opdivo and Yervoy combination showed a statistically significant and clinically meaningful improvement in overall survival (OS) compared to the investigator’s choice of lenvatinib or sorafenib. While the Opdivo and Yervoy combination is already an established second-line treatment for advanced HCC, these findings support its potential use as a first-line therapy. The safety profile for the combination remained consistent with previously reported data, and no new safety concerns were identified.
About CheckMate -9DW
CheckMate -9DW is a Phase 3 randomized, open-label trial evaluating the combination of Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib monotherapy in patients with unresectable or advanced hepatocellular carcinoma who have not received prior systemic therapy.
668 patients were randomized to receive Opdivo plus Yervoy ( Opdivo 1mg/kg plus Yervoy 3 mg/kg Q3W for up to four doses, followed by Opdivo monotherapy 480 mg for a maximum duration of 2 years) infusion, or single agent lenvatinib or sorafenib as oral capsules in the control arm. The primary endpoint of the trial is overall survival and key secondary endpoints include objective response rate and time to symptom deterioration.
