Bristol Myers' Opdivo Plus Yervoy Combo Therapy Secures European Approval For Untreated Liver Cancer Patients

On Friday, the European Commission (EC) approved Bristol Myers Squibb & Co’s BMY Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC), a type of liver cancer.

The decision is based on results from the CheckMate -9DW study. Results showed that dual immunotherapy treatment with Opdivo plus Yervoy led to a statistically significant and clinically meaningful improvement in overall survival (OS), the trial’s primary endpoint.

In the trial, 85% of patients in the comparator arm were treated with lenvatinib and 15% with sorafenib.

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The median OS was 23.7 months for Opdivo plus Yervoy compared to 20.6 months with the investigator’s choice of lenvatinib or sorafenib.

The OS benefit was observed across clinically relevant patient subgroups. The trial also showed an overall response rate (ORR) of 36.1% compared to 13.2% of patients treated with lenvatinib or sorafenib and a deeper response with Opdivo plus Yervoy.

The safety profile for the combination of Opdivo plus Yervoy remained consistent with previously reported data and was manageable with established protocols, with no new safety signals identified.

In August 2024, the U.S. FDA accepted the company’s supplemental Biologics License Application for Opdivo plus Yervoy as a potential first-line treatment option for adult patients with unresectable HCC and assigned a Prescription Drug User Fee Act goal date of April 21, 2025.

The combination of Opdivo plus Yervoy was granted accelerated approval by the U.S. FDA in 2020 as a second-line treatment for patients with advanced HCC based on Phase 2 CheckMate -040 trial results.

In February, the FDA accepted the supplemental biologics license application (sBLA) for Bristol Myers Squibb’s Opdivo plus Yervoy as a potential first-line treatment option for adult and pediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient colorectal cancer (mCRC).

The FDA granted the application Breakthrough Therapy Designation and Priority Review status. It also assigned a Prescription Drug User Fee Act goal date of June 23, 2025.

Price Action: BMY stock is down 0.14% at $60.09 during the premarket session at the last check Friday.

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