国内首个肝细胞癌一线双免疫联合疗法获批上市

Core Viewpoint - Bristol-Myers Squibb's immunotherapy drugs, Opdivo (nivolumab) and Yervoy (ipilimumab), have received approval from the National Medical Products Administration for a new indication as a first-line treatment for adult patients with unresectable or advanced hepatocellular carcinoma, making it the first and only approved dual immunotherapy regimen for this condition in China [1][2]. Group 1 - The approval is based on the Phase III CheckMate-9DW study, which is the first global trial to demonstrate the efficacy of an immunotherapy regimen for first-line treatment of hepatocellular carcinoma, showing significant superiority over previous standard treatments (lenvatinib or sorafenib) [1][2]. - The CheckMate-9DW study involved a global multi-center, randomized controlled design, comparing the Opdivo and Yervoy regimen against investigator's choice of lenvatinib or sorafenib, with 85% of the control group receiving lenvatinib [2]. - The primary endpoint results indicated that the median overall survival (mOS) for the Opdivo and Yervoy group was 23.7 months, compared to 20.6 months for the control group, representing a 21% reduction in the risk of death [2]. Group 2 - The secondary endpoint results showed that the objective response rate (ORR) for the Opdivo and Yervoy group was 36%, while the control group had an ORR of 13%; the median duration of response (mDOR) was 30.4 months for the treatment group versus 12.9 months for the control group [2]. - The overall safety profile of the Opdivo and Yervoy regimen was manageable, with no new safety signals identified; the incidence of grade 3/4 treatment-related adverse events was 41% for the treatment group and 42% for the control group [2]. - The principal investigator in China emphasized that the dual immunotherapy regimen not only has a high response rate but also significantly extends both the duration of response and overall survival, indicating its excellent short-term efficacy and long-term survival benefits [2]. Group 3 - Opdivo and Yervoy were approved in October 2015, becoming the first immuno-oncology drug combination approved by regulatory authorities globally, and have since been approved in over 50 countries for seven types of cancer, including melanoma, kidney cancer, colorectal cancer, liver cancer, lung cancer, mesothelioma, and esophageal cancer [3]. - The Opdivo and Yervoy regimen has been approved in China for multiple cancer types, including mesothelioma, colorectal cancer, and hepatocellular carcinoma [3].