Opdivo + Yervoy Improve Survival Over Lenvatinib or Sorafenib in Advanced Hepatocellular Carcinoma

June 04, 2024 - Bristol Myers Squibb has unveiled the Phase 3 results of the CheckMate-9DW trial at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. This study highlights the efficacy of a dual immunotherapy regimen consisting of Opdivo® (nivolumab) and Yervoy® (ipilimumab) for patients with unresectable hepatocellular carcinoma (HCC), showing a marked improvement over the use of lenvatinib or sorafenib.

Key Trial Findings

The CheckMate-9DW trial involved approximately 668 patients with advanced HCC who had not received prior systemic therapy. These participants were randomized to receive either the Opdivo plus Yervoy combination or the investigator’s choice of lenvatinib or sorafenib. The primary goal of the trial was to measure overall survival, while secondary objectives included the objective response rate (ORR) and time to symptom deterioration.

After a median follow-up of 35.2 months, data revealed that the Opdivo and Yervoy combination significantly extended survival compared to the alternatives. The ORR for the dual therapy was more than double that of lenvatinib or sorafenib. Specifically, patients treated with Opdivo and Yervoy had an ORR of 32%, compared to 14% in the control group. The median overall survival was also superior, clocking in at 22.2 months versus 19.6 months for the control arm.

Safety Profile

The safety profile of the dual therapy was consistent with previous studies. Treatment-related adverse events (TRAEs) of any grade were reported in 84% of patients receiving Opdivo and Yervoy, compared to 91% for those treated with lenvatinib or sorafenib. Severe TRAEs (Grade 3/4) were observed in 41% of the Opdivo-Yervoy group and 42% in the control group, indicating manageable safety concerns within the established protocols.

Expert Insights

Dr. Peter R. Galle from the University Medical Center, Mainz, emphasized the significance of these findings, noting that advanced HCC treatment options have historically been limited. "These results from CheckMate-9DW underscore the efficacy of nivolumab and ipilimumab in extending survival, which is a promising development," he stated.

Dr. Dana Walker, Vice President of Bristol Myers Squibb, echoed this optimism. "The combination of Opdivo and Yervoy is already an established second-line treatment for advanced HCC. These findings now demonstrate its significant benefits in a first-line setting," she said. The company plans to engage with health authorities to potentially make this dual immunotherapy available to a broader patient group.

Background on Hepatocellular Carcinoma

Hepatocellular carcinoma is the most common form of primary liver cancer, accounting for 90% of cases. It is often diagnosed at an advanced stage, leading to poor prognoses and limited treatment options. The primary causes of HCC are chronic infections with hepatitis B or C viruses, though rising instances of metabolic syndrome and nonalcoholic steatohepatitis (NASH) are also contributing to its prevalence.

About Opdivo and Yervoy

Opdivo is a PD-1 immune checkpoint inhibitor that helps activate the body’s immune system to fight cancer. It has become a critical treatment across multiple cancers and is approved in over 65 countries. Yervoy, on the other hand, is a monoclonal antibody that targets CTLA-4, augmenting T-cell activation and proliferation.

Conclusion

The CheckMate-9DW trial represents a significant advancement in the fight against hepatocellular carcinoma. Bristol Myers Squibb's commitment to improving cancer care through innovative therapies continues to yield promising treatments that could transform patient outcomes. The company is dedicated to further exploring the potential of these therapies to offer hope to millions of cancer patients worldwide.

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