ASCO24: Opdivo Plus Yervoy Significantly Improves Overall Survival in Liver Cancer

The data from the CheckMate -9DW trial, presented at the ASCO annual meeting, show that the Opdivo-Yervoy therapy could become the first-line treatment for hepatocellular carcinoma. This dual immunotherapy combination extended median survival to 23.7 months —a 21% improvement in survival risk— and notably increased the objective response rate to 36% from 13%.

At the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting, Bristol Myers Squibb presented positive results from the Phase 3 CheckMate -9DW trial. This trial evaluated the dual immunotherapy combination of Opdivo® (nivolumab) and Yervoy® (ipilimumab) against lenvatinib or sorafenib as a first-line treatment for patients with unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer.

This regimen increased median overall survival to 23.7 months from 20.6 months compared to standard treatments. Additionally, it achieved a 36% objective response rate, more than doubling the 13% rate seen with standard therapies, with response durations of 30.4 months versus 12.9 months.

New Hope for Advanced HCC Patients

HCC is notoriously difficult to treat in its advanced stages, with most patients facing limited and often ineffective treatment options.

“Despite recent advances in the treatment of HCC, prognosis remains poor for patients with advanced HCC. These data from  confirm the efficacy of the combination of nivolumab and ipilimumab and ability to extend survival, which is very encouraging,” said Dr. Peter R. Galle, of the University Medical Center, Mainz.

Key Findings from the CheckMate -9DW Trial

• Overall Survival: Patients treated with Opdivo and Yervoy had a median overall survival of 23.7 months, compared to 20.6 months for those on standard therapies—a statistically significant improvement.
• Response Rates: The objective response rate for the combination therapy was 36%, more than double the response rate observed with the standard treatments. Moreover, the combination therapy achieved a complete response rate of 7%, compared to only 2% in the control group.
• Duration of Response: The median duration of response was notably longer with the combination therapy at 30.4 months, compared to 12.9 months for the standard treatments.

Clinical Impact and Safety

The enhanced efficacy of the Opdivo and Yervoy combination does not come at the cost of increased side effects. The safety profile was manageable and consistent with previous data, with treatment-related adverse events occurring in 84% of patients receiving the combination therapy, closely aligning with the 91% observed in those receiving standard treatments.

“The combination of Opdivo plus Yervoy has been an established second-line treatment for patients with advanced HCC and, with these results, we can demonstrate that Opdivo plus Yervoy significantly increases survival and other key efficacy measures in the first-line setting for patients with advanced disease. We look forward to discussing these data with health authorities,” said Dr. Dana Walker, Vice President at Bristol Myers Squibb. 

Liver cancer remains a major health challenge globally, being the third most common cause of cancer death. The promising results from the CheckMate -9DW trial represent a significant step forward in the fight against this aggressive cancer, with the potential to improve survival and quality of life for patients worldwide.