BMS Reports Positive Phase 3 Results for Opdivo/Yervoy in Liver Cancer

Bristol Myers Squibb (BMS) has announced successful outcomes from a phase 3 study examining the efficacy of Opdivo (nivolumab) combined with Yervoy (ipilimumab) as an initial treatment for unresectable hepatocellular carcinoma (HCC). This CheckMate-9DW trial compared the dual immunotherapy regimen to the investigator’s choice of lenvatinib or sorafenib monotherapy in patients with advanced HCC who had not received prior systemic therapy.

Hepatocellular carcinoma is responsible for approximately 90% of liver cancer cases, and it is frequently diagnosed at a stage where few effective treatment options are available. At the American Society of Clinical Oncology Annual Meeting, the trial results highlighted the significant benefits of the Opdivo/Yervoy combination in improving overall survival, a primary endpoint in the study, with a median follow-up period of around 35.2 months.

Specifically, patients receiving the dual therapy had a median overall survival of 23.7 months, compared to 20.6 months for those treated with lenvatinib or sorafenib. The survival advantage was generally consistent across various patient subgroups. Additionally, the combination therapy showed a statistically significant and clinically meaningful improvement in the objective response rate, a key secondary endpoint. The response rate for patients treated with Opdivo plus Yervoy was 36%, compared to 13% in those receiving lenvatinib or sorafenib. The complete response rate and symptom deterioration risk also saw improvements with the combination therapy.

Opdivo plus Yervoy-based combinations are already approved for several indications, including for adults with HCC who have been previously treated with sorafenib. Dana Walker, Vice President and Global Programme Lead for gastrointestinal and genitourinary cancers at BMS, emphasized the significance of these findings. She noted that the combination therapy has been a recognized second-line treatment for advanced HCC and that these results demonstrate its effectiveness as a first-line treatment, significantly enhancing survival and other key efficacy measures for patients with advanced disease.

Walker expressed BMS's eagerness to discuss these findings with health authorities, with the aim of making the dual immunotherapy combination available to a broader patient population. This development follows closely on the heels of another significant approval for Opdivo. Just one week prior, the European Commission approved Opdivo in combination with cisplatin and gemcitabine as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma, which constitutes about 90% of bladder cancer cases.

In summary, the positive results from the CheckMate-9DW trial underscore the potential of Opdivo and Yervoy as a first-line treatment option for advanced HCC, offering new hope for patients facing this challenging diagnosis. BMS is looking forward to further discussions with health authorities to potentially expand the availability of this promising treatment regimen.