Bristol Myers Squibb’s (BMS) dual immunotherapy combination has been recommended by the European Medicines Agency’s human medicines committee to treat hepatocellular carcinoma (HCC), the most common type of liver cancer.
The Committee for Medicinal Products for Human Use (CHMP) has recommended that Opdivo (nivolumab) plus Yervoy (ipilimumab) be approved as a first-line treatment for adults with unresectable or advanced cases of the disease.
HCC accounts for approximately 90% of all liver cancer cases globally and is often diagnosed at an advanced stage, at which point effective treatment options are limited.
The CHMP’s decision on the combination was based on positive results from the phase 3 CheckMate-9DW trial, which demonstrated a statistically significant and clinically meaningful improvement in overall survival with Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib in this patient population.
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.
The European Commission (EC) will now review the CHMP’s recommendation as it makes a decision on the combination in this indication.
Dana Walker, vice president, Opdivo global programme lead, BMS, said: “HCC is the predominant type of liver cancer globally, including in the EU, and when diagnosed at the advanced or unresectable stage, prognosis and overall survival remain sub-optimal with conventional therapy.
“The positive opinion received by the CHMP is a significant step forward in providing patients with additional treatment options, and we look forward to the upcoming EC review and the potential to expand the treatment landscape for adult patients with unresectable or advanced HCC.”
The positive opinion comes just days after BMS shared promising results from the ongoing phase 3 CheckMate-8HW trial of Opdivo plus Yervoy in patients with microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer.