Bristol Myers Squibb (BMS) has announced positive phase 3 results for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) to treat patients with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
The CheckMate-9DW trial evaluated the combination compared to investigators choice of sorafenib or lenvatinib monotherapy in 668 patients living with the advanced liver cancer.
Liver cancer is the third-most frequent cause of cancer death globally. HCC is the most common form of primary liver cancer, accounting for 90% of all liver cancer cases.
Up to 70% of patients living with the condition will experience a recurrence within five years.
BMS’ Opdivo and Yervoy combination was the first immune-oncology combination to receive regulatory approval in 2015 to treat metastatic melanoma and is currently approved in more than 50 countries, including the US and EU.
Results showed that the trial met its primary endpoint, with Opdivo plus Yervoy demonstrating a statistically significant and clinically meaningful improvement in overall survival compared to investigator’s choice of sorafenib or lenvatinib.
In addition, the safety profile for the dual immunotherapy remained consistent with previous data, with no new safety signals indicated.
Dana Walker, vice president, global programme lead, gastrointestinal and genitourinary cancers, BMS, commented: “Advanced stage liver cancer patients remain in need of additional treatment options that may help improve survival.
“The overall survival benefit demonstrated by the combination of Opdivo plus Yervoy in the CheckMate-9DW trial demonstrates its potential to improve outcomes compared to well-established TKI treatment options.”
The programmed PD-1 immune checkpoint inhibitor, Opdivo, is designed to harness the body’s immune system to restore anti-tumour immune response and is already approved in more than 65 countries, including the US, EU, Japan and China. In 2014, it became the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world.
Yervoy is a recombinant human monoclonal antibody that binds to CTLA-4 and blocks its interaction with its ligands, CD80 and CD86, augmenting T-cell activation and proliferation while increasing anti-tumour immune responses.
Approved in more than 50 countries, the US Food and Drug Administration approved Yervoy for the same indication as a monotherapy for patients with unresectable or metastatic melanoma in 2011.