US giant Bristol-Myers Squibb (BMS, NYSE: BMY) announced receiving marketing approval from the European Commission (EC) for its Opdivo (nivolumab) combined with Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC). This approval marks a significant advancement in treatment options for this aggressive form of liver cancer.
Clinical Trial Results
The EC’s decision was based on positive results from the CheckMate-9DW study, which met its primary endpoint. The median overall survival (OS) was 23.7 months (95% CI: 18.8–29.4) for the Opdivo/Yervoy combination compared to 20.6 months (95% CI: 17.5–22.5) with the investigator’s choice of lenvatinib or sorafenib (HR: 0.79 (0.65–0.96); p=0.018). The OS benefit was observed across clinically relevant patient subgroups.
Additional Efficacy Data
The trial also demonstrated an overall response rate (ORR) of 36.1% (95% CI: 31-41.5) for the Opdivo/Yervoy combo, compared to 13.2% for patients treated with lenvatinib or sorafenib. Moreover, the combination therapy showed a deeper response, further highlighting its clinical benefits.
Safety Profile
The safety profile for the Opdivo/Yervoy combination remained consistent with previous findings, indicating no new safety concerns.
Previous and Pending Approvals
The Opdivo/Yervoy combination was previously approved in the European Union as a first-line treatment for adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (mCRC) in December last year. The combination is also awaiting regulatory decisions in the US as a first-line treatment for HCC, with the FDA expected to act on its market filing before April 21, 2025.-Fineline Info & Tech
Leave a Reply