Bristol Myers Squibb (BMS) has shared positive results from a late stage study evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for unresectable hepatocellular carcinoma (HCC).
The phase 3 CheckMate-9DW trial has been comparing the dual immunotherapy combination to investigator’s choice of lenvatinib or sorafenib monotherapy in patients with advanced HCC who have not received prior systemic therapy.
HCC accounts for approximately 90% of all liver cancer cases and is often diagnosed at an advanced stage, at which point effective treatment options are limited.
According to the results presented at this year’s American Society of Clinical Oncology Annual Meeting, the Opdivo/Yervoy combination demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of overall survival after a median follow-up of approximately 35.2 months.
Median overall survival was 23.7 months for Opdivo plus Yervoy compared to 20.6 months with lenvatinib or sorafenib, with the survival benefit found to be generally consistent across patient subgroups.
A statistically significant and clinically meaningful improvement was also observed in the key secondary endpoint of objective response rate, which was 36% for Opdivo plus Yervoy compared to 13% with lenvatinib or sorafenib, and improvements in complete response rate symptom deterioration risk were seen for the combination.
Opdivo plus Yervoy-based combinations already hold approvals for a range of indications, including for adults with HCC who have been previously treated with sorafenib.
Dana Walker, vice president, global programme lead, gastrointestinal and genitourinary cancers, BMS, said: “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 this data with health authorities and potentially bringing the dual immunotherapy combination of Opdivo plus Yervoy to more patients.”
The readout comes just one week after Opdivo was approved by the European Commission in combination with cisplatin and gemcitabine as a first-line treatment in adult patients with unresectable or metastatic cases of urothelial carcinoma, which accounts for about 90% of all bladder cancer diagnoses.