First-Line Nivolumab/Ipilimumab Improves Survival in Hepatocellular Cancer


The phase 3 CheckMate -9DW study of frontline nivolumab plus ipilimumab in hepatocellular cancer met its primary end point of overall survival vs sorafenib or lenvatinib.

Human Liver Anatomy: © nerthuz -

Human Liver Anatomy: © nerthuz -

The first-line combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) improved overall survival (OS) vs investigator’s choice of sorafenib (Nexavar) or lenvatinib (Lenvima) in patients with previously untreated advanced hepatocellular cancer (HCC), meeting the primary end point of the phase 3 CheckMate -9DW study (NCT04039607).1

According to a prespecified analysis, the immunotherapy duo delivered a statistically significant, clinically meaningful improvement in OS vs sorafenib or lenvatinib, and the safety profile of the combination was in line with previous reports.

Findings from a complete analysis will be shared at an upcoming medical conference and with relevant health authorities.

“Advanced stage liver cancer patients remain in need of additional treatment options that may help improve survival,” said Dana Walker, MD, MCSE, vice president, global program lead, gastrointestinal and genitourinary cancers, Bristol Myers Squibb, in a press release. “The overall survival benefit demonstrated by the combination of [nivolumab] plus [ipilimumab] in the CheckMate -9DW trial demonstrates its potential to improve outcomes compared to well-established [tyrosine kinase inhibitor] treatment options.”

In 2021, nivolumab plus ipilimumab was approved for the treatment of HCC that progressed following sorafenib treatment. The combination of nivolumab plus ipilimumab is indicated for unresectable malignant pleural mesothelioma, advanced renal cell carcinoma, metastatic melanoma, and unresectable advanced or metastatic esophageal squamous cell carcinoma in the first line.

Nivolumab plus ipilimumab is also indicated for microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer that has progressed following chemotherapy.

About the Phase 3 CheckMate-9DW Study

The phase 3, randomized, global CheckMate -9DW has an approximate enrollment of 668 patients with advanced HCC.1 The primary end point is OS, and secondary end points are objective response rate, duration of response, and time to symptom deterioration.2

Patients were randomized to receive 1 mg/kg intravenous nivolumab plus 3 mg/kg ipilimumab for up to 4 doses followed by nivolumab monotherapy or oral sorafenib or lenvatinib, depending on investigators’ recommendations.1

Patients were eligible for enrollment in the study if they had histologically confirmed HCC, at least 1 measurable lesion per RECIST v1.1, a Child-Pugh score of 5 or 6, and an ECOG performance status of 0 or 1.2 Patients who previously received a liver transplant; had a history of hepatic encephalopathy; had active brain or leptomeningeal metastases; or had known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC were not eligible for participation.

1. Bristol Myers Squibb announces Checkmate -9DW trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) meets primary endpoint of overall survival for the first-line treatment of advanced hepatocellular carcinoma. News release. Bristol Myers Squibb. March 20, 2024. Accessed March 20, 2024.
2. A study of nivolumab in combination with ipilimumab in participants with advanced hepatocellular carcinoma (CheckMate 9DW). Updated January 18, 2024. Accessed March 20, 2024.
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