By Fineline Cube 
Bristol-Myers Squibb (BMS, NYSE: BMY) announced that it has received approval from China’s National Medical Products Administration (NMPA) for its anti-PD-1 drug Opdivo (nivolumab) in combination with Yervoy (ipilimumab) as a first-line treatment for unresectable or advanced hepatocellular carcinoma (HCC). This approval makes the Opdivo/Yervoy combination the first and currently only immunotherapy regimen approved for first-line HCC treatment in China.
Clinical Trial Results
The approval is supported by results from the Phase III CheckMate-9DW trial, which demonstrated superior efficacy of the Opdivo/Yervoy combination compared to previous standard treatments (lenvatinib or sorafenib). Key findings include:
- Median Overall Survival (OS): 23.7 months for the combination vs. 20.6 months for the control group, representing a 21% reduction in the risk of death (P=0.018).
- Objective Response Rate (ORR): 36% for the combination vs. 13% for the control group.
- Median Duration of Response (mDOR): 30.4 months for the combination, more than double that of the control group.
Safety Profile
The combination therapy demonstrated an overall safety and tolerability profile consistent with previous findings, with no new safety signals identified. The incidence of grade 3/4 treatment-related adverse events was 41% in the combination group, comparable to 42% in the control group.-Fineline Info & Tech