On March 20, 2024 Bristol Myers Squibb (NYSE: BMY) reported the Phase 3 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 (Press release, Bristol-Myers Squibb, MAR 20, 2024, View Source;9DW-Trial-Evaluating-Opdivo-nivolumab-Plus-Yervoy-ipilimumab-Meets-Primary-Endpoint-of-Overall-Survival-for-the-First-Line-Treatment-of-Advanced-Hepatocellular-Carcinoma/default.aspx [SID1234641291]).

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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.

Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -9DW clinical trial.

About CheckMate -9DW

CheckMate -9DW is a Phase 3 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.

About Hepatocellular Carcinoma

Liver cancer is the third most frequent cause of cancer death worldwide. Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer and accounts for 90% of all liver cancers. HCC is often diagnosed in an advanced stage, where effective treatment options are limited and are usually associated with poor outcomes.

Up to 70% of patients experience recurrence within five years, particularly those still considered to be at high risk after surgery or ablation. While most cases of HCC are caused by hepatitis B virus (HBV) or hepatitis C virus (HCV) infections, metabolic syndrome and nonalcoholic steatohepatitis (NASH) are rising in prevalence and expected to contribute to increased rates of HCC.