The US Food and Drug Administration (FDA) has accepted the supplemental biologics licence application (sBLA) filed by Bristol Myers Squibb (BMS) for Opdivo (nivolumab) and Yervoy (ipilimumab) as a potential first-line treatment for adults with unresectable hepatocellular carcinoma (HCC), the most common primary liver cancer type.
The FDA has set a Prescription Drug User Fee Act goal date of 21 April 2025 for this application.
Opdivo, a PD-1 immune checkpoint inhibitor, is designed to harness the body’s immune system to restore anti-tumour immune response.
Yervoy, a CTLA-4 inhibitor, is approved for unresectable or metastatic melanoma in 50 countries and is part of a broad development programme across multiple tumour types.
The sBLA submission is supported by results from the Phase III CheckMate -9DW trial, which showed a statistically significant and clinically meaningful improvement in overall survival (OS) for the combination therapy compared to the investigator’s choice of lenvatinib or sorafenib.
This combination is already an established second-line treatment for advanced HCC, and these findings could extend its use to the first-line setting.
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The CheckMate 9DW randomised, open-label study compared the Opdivo plus Yervoy combination to lenvatinib or sorafenib monotherapy in patients with unresectable or advanced HCC who had not previously received systemic therapy.
It involved 668 patients, with the primary endpoint being OS and key secondary endpoints including time to symptom deterioration and objective response rate.
Bristol Myers Squibb gastrointestinal and genitourinary cancers, global programme lead, vice-president Dana Walker stated: “HCC is the most common form of liver cancer and is often diagnosed when surgery is no longer an option.
“Opdivo plus Yervoy showed superior survival benefit compared to other available treatment options, and we look forward to working with the FDA to advance our application to potentially bring a new first-line treatment option to patients.”
In July 2024, Bristol Myers Squibb announced that the European Medicines Agency will commence a review of its application covering the Opdivo/Yervoy combination’s use in patients with advanced liver cancer.
