FDA Approves BMS's Nivolumab plus Ipilimumab as First-Line Therapy for Unresectable or Advanced Hepatocellular Carcinoma

On April 11, the U.S. FDA announced the approval of Bristol-Myers Squibb's Opdivo.(Nivolumab, Nivolumab)Yervoy(Ipilimumab, Yipimu Monoclonal Antibody)A new indication for combination therapy has been launched.For unresectable or advanced hepatocellular carcinoma（HCC）First-line Treatment for Adult Patients。Not long ago, this combination therapy has been approved in China, becoming the first approved first-line dual immunotherapy for hepatocellular carcinoma in China.

ScreenshotSource: FDA Official Website

Nivolumab isPD-1 Inhibitor,Ipilimumab is a CTLA-4 inhibitor. The combination therapy of these two drugs was first approved in 2015, marking the world's first immuno-oncology combination therapy to receive regulatory approval. Currently, this combination therapy has been approved for multiple types of cancer across more than 50 countries and regions, covering melanoma, renal cancer, colorectal cancer, liver cancer, lung cancer, pleural tumors, esophageal cancer, and more.

The approval of the new indication for Nivolumab + Ipilimumab in the United States is mainly based on the results of the Phase III CheckMate-9DW study. This is a global multicenter, Phase III randomized controlled study aimed at evaluating the efficacy and safety of the combination therapy compared to investigator’s choice of Lenvatinib or Sorafenib in patients with unresectable HCC receiving first-line treatment, where 85% of the control group patients used Lenvatinib.

According to data presented at the 2024 ASCO Annual Meeting:

• Nivolumab + Ipilimumab Combination Therapy GroupMedian Overall Survival（mOS）For 23.7 months(vs control group was 20.6 months)，Significantly Reduce the Risk of Death by 21%。

• In terms of secondary endpoints, the combination therapy groupObjective Response Rate（ORR）For 36%, compared with the control group（13%）Improved nearly 3 times;Median Duration of Response（mDOR）Reaching 30.4 Months, compared with the control group(12.9 months)Improved more than 2 times.

• The overall safety of the combination therapy regimen is controllable, with no new safety signals identified, and the incidence of grade 3/4 treatment-related adverse events was 41%.(vs control group 42%)。

These results indicate that, compared with lenvatinib or sorafenib, nivolumab combined with ipilimumab demonstrated a statistically significant OS benefit, higher ORR, and durable responses in previously untreated patients with unresectable or advanced HCC, along with manageable safety.

CheckMate-9DW Study OS Results

Liver cancer is a common cause of cancer-related death worldwide. HCC is the most prevalent type of primary liver cancer, accounting for approximately 75%-85% of all liver cancer cases. HCC is often diagnosed at an advanced stage, where effective treatment options are limited and the prognosis is usually poor. Up to 70% of patients experience recurrence within 5 years, particularly those considered at high risk after surgery or ablation.

BMS once noted in a press release that the CheckMate-9DW study was conducted globally.First confirmed: Immunotherapy regimen for first-line treatment of hepatocellular carcinoma shows significantly superior efficacy compared to two previous standard-of-care drugs.. The approval of this combination therapy of Nivolumab and Ipilimumab will bring a new first-line treatment option for patients.