CheckMate-9DW trial evaluating Opdivo (nivolumab) + Yervoy (ipilimumab) meets primary endpoint of overall survival for the first-line treatment of advanced hepatocellular carcinoma – BMS

Bristol Myers Squibb announced the Phase III CheckMate -9DW trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for patients with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy met its primary endpoint of improved overall survival (OS) compared to investigator’s choice of sorafenib or lenvatinib at a pre-specified interim analysis.

The dual immunotherapy combination of Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful improvement in OS compared to investigator’s choice of sorafenib or lenvatinib.

The safety profile for the combination of Opdivo plus Yervoy remained consistent with previously reported data and was manageable with established protocols, with no new safety signals identified.

“Advanced stage liver cancer patients remain in need of additional treatment options that may help improve survival,” said Dana Walker, M.D., M.S.C.E., vice president, global program lead, gastrointestinal and genitourinary cancers, Bristol Myers Squibb. “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 company will complete a full evaluation of the data and work with investigators to share the results with the scientific community at an upcoming medical conference, as well as discuss with health authorities.

About CheckMate -9DW : CheckMate -9DW is a Phase III randomized, open-label trial evaluating the combination of Opdivo plus Yervoy compared to investigator’s choice of sorafenib or lenvatinib monotherapy in patients with advanced hepatocellular carcinoma who have not received prior systemic therapy. Approximately 668 patients were randomized to receive Opdivo plus Yervoy (Opdivo 1mg/kg plus Yervoy 3 mg/kg Q3W for up to four doses, followed by Opdivo monotherapy 480 mg Q4W) infusion, or single agent sorafenib or lenvatinib as oral capsules in the control arm. The primary endpoint of the trial is overall survival and key secondary endpoints include objective response rate and time to symptom deterioration.