Bristol Myers: Opdivo-Yervoy Combo Boosts Survival in Advanced HCC vs. Lenvatinib or Sorafenib

In a groundbreaking development, Bristol Myers Squibb (NYSE: BMY) unveiled the results of the Phase 3 CheckMate -9DW clinical trial, which evaluated the dual immunotherapy regimen of Opdivo® (nivolumab) plus Yervoy® (ipilimumab) against lenvatinib or sorafenib for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). These findings were presented at the 2024 American Society of Clinical Oncology (ASCO®) Annual Meeting, highlighting significant advancements in HCC therapy.

Enhanced Survival Rates and Response Durability

The CheckMate -9DW trial, which included a median follow-up period of approximately 35.2 months, demonstrated that the combination of Opdivo plus Yervoy significantly improved overall survival (OS) compared to lenvatinib or sorafenib. The median OS for patients treated with Opdivo plus Yervoy was 23.7 months, a notable increase from the 20.6 months observed in those treated with lenvatinib or sorafenib. This improvement in survival rates was not only statistically significant but also clinically meaningful, with a hazard ratio (HR) of 0.79 and a p-value of 0.018, indicating a 21% reduction in the risk of death.

Furthermore, the objective response rate (ORR) for Opdivo plus Yervoy was substantially higher, at 36%, compared to just 13% for lenvatinib or sorafenib. The combination therapy also achieved a complete response (CR) rate of 7%, significantly higher than the 2% CR rate seen with lenvatinib or sorafenib. Notably, the median duration of response for Opdivo plus Yervoy was an impressive 30.4 months, compared to 12.9 months for the other treatments.

Reduced Symptom Deterioration and Manageable Safety Profile

Opdivo plus Yervoy also demonstrated a 24% reduction in the risk of symptom deterioration compared to lenvatinib or sorafenib, with a hazard ratio of 0.76 and a p-value of 0.0059. This highlights the dual immunotherapy's potential to not only extend life but also improve the quality of life for patients with advanced HCC.

The safety profile of the Opdivo and Yervoy combination was consistent with previous findings and manageable with existing protocols. Treatment-related adverse events (TRAEs) of any grade were reported in 84% of patients on the dual immunotherapy, compared to 91% of those on lenvatinib or sorafenib. Grade 3/4 TRAEs were observed in 41% of patients receiving Opdivo plus Yervoy and 42% of those on the comparator drugs, indicating a similar risk level.

Expert Opinions and Future Prospects

Dr. Peter R. Galle from the University Medical Center, Mainz, emphasized the significance of these results, noting the ongoing challenges in treating advanced HCC and the need for therapies that not only improve survival but also delay disease progression. Dr. Dana Walker, vice president and global program lead for gastrointestinal and genitourinary cancers at Bristol Myers Squibb, highlighted the breakthrough nature of the findings, which establish Opdivo plus Yervoy as a potent first-line treatment option for advanced HCC.

About the CheckMate -9DW Trial

The CheckMate -9DW trial is a Phase 3, randomized, open-label study comparing the effectiveness of Opdivo plus Yervoy against lenvatinib or sorafenib in patients with advanced HCC who had not received prior systemic therapy. The trial enrolled approximately 668 patients, with those in the experimental arm receiving a regimen of Opdivo 1 mg/kg and Yervoy 3 mg/kg every three weeks for up to four doses, followed by Opdivo monotherapy. The primary endpoint was overall survival, with key secondary endpoints including objective response rate and time to symptom deterioration.

Hepatocellular Carcinoma Overview

Liver cancer, particularly HCC, remains a significant global health challenge, being the third most common cause of cancer-related deaths worldwide. HCC, accounting for 90% of liver cancer cases, is often diagnosed at advanced stages with limited treatment options and poor prognoses. The high recurrence rate within five years, especially among high-risk patients post-surgery or ablation, underscores the critical need for effective first-line therapies.

Conclusion

The promising results from the CheckMate -9DW trial represent a significant advancement in the treatment of advanced HCC, offering hope for improved survival rates and quality of life for patients. Bristol Myers Squibb's commitment to innovative cancer therapies continues to push the boundaries of medical science, aiming to transform the lives of patients through cutting-edge research and development.

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