Zhenggang Ren, Yao Huang, Yabing Guo, Ming-Mo Hou, Wei Wang, Ming Kuang, Chunyi Hao, Wentao Wang, Yanqiao Zhang, Tianqiang Song, Chaoliu Dai, Hsing-Tao Kuo, Zinan Bao, Yunxia Zuo, Lei Wang, Fuxiang Zhu, Jia Fan
{"title":"AdvanTIG-206: ociperlimab + tislelizumab和BAT1706（贝伐单抗生物类似药）与tislelizumab和BAT1706治疗一线肝细胞癌的II期随机研究","authors":"Zhenggang Ren, Yao Huang, Yabing Guo, Ming-Mo Hou, Wei Wang, Ming Kuang, Chunyi Hao, Wentao Wang, Yanqiao Zhang, Tianqiang Song, Chaoliu Dai, Hsing-Tao Kuo, Zinan Bao, Yunxia Zuo, Lei Wang, Fuxiang Zhu, Jia Fan","doi":"10.1007/s00262-026-04399-8","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Patients with hepatocellular carcinoma (HCC) have an unmet need for new therapies that improve survival. This phase II trial investigated the efficacy and safety of ociperlimab and tislelizumab plus BAT1706 (a bevacizumab biosimilar) in patients with first-line HCC.</p><p><strong>Methods: </strong>In this phase II, multicenter, randomized, multi-arm, open-label trial, patients with advanced HCC received ociperlimab and tislelizumab plus BAT1706 (Arm A) or tislelizumab plus BAT1706 (Arm B). The primary objective was to evaluate efficacy using objective response rate (ORR) assessed by the investigator per RESIST v1.1 for Arms A and B.</p><p><strong>Results: </strong>94 patients were randomized to Arm A (N = 62) and Arm B (N = 32). Confirmed ORR (95% confidence interval) was 37.1% (25.2-50.3) for Arm A and 40.6% (23.7-59.4) for Arm B. In Arms A and B, respectively, 90.3% and 80.6% of patients experienced treatment-related treatment-emergent adverse events (TEAEs), 59.7% and 32.3% experienced Grade ≥ 3 treatment-related TEAEs and 22.6% and 9.7% experienced treatment-related TEAEs leading to treatment discontinuation. Immune-mediated adverse events were reported in 50.0% of patients in Arm A and 45.2% of patients in Arm B. Infusion-related reactions occurred in a single patient in Arm A.</p><p><strong>Conclusion: </strong>In patients with advanced HCC, tislelizumab plus BAT1706 demonstrated promising ORR, while adding ociperlimab was not associated with improved efficacy. The safety profile of ociperlimab and tislelizumab plus BAT1706 was tolerable and manageable, with no new safety signals identified.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov: NCT04948697 (September 20, 2021).</p>","PeriodicalId":520581,"journal":{"name":"Cancer immunology, immunotherapy : CII","volume":"75 5","pages":""},"PeriodicalIF":5.1000,"publicationDate":"2026-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13125556/pdf/","citationCount":"0","resultStr":"{\"title\":\"AdvanTIG-206: a phase II, randomized study of ociperlimab plus tislelizumab and BAT1706 (bevacizumab biosimilar) versus tislelizumab and BAT1706 in first-line hepatocellular carcinoma.\",\"authors\":\"Zhenggang Ren, Yao Huang, Yabing Guo, Ming-Mo Hou, Wei Wang, Ming Kuang, Chunyi Hao, Wentao Wang, Yanqiao Zhang, Tianqiang Song, Chaoliu Dai, Hsing-Tao Kuo, Zinan Bao, Yunxia Zuo, Lei Wang, Fuxiang Zhu, Jia Fan\",\"doi\":\"10.1007/s00262-026-04399-8\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Patients with hepatocellular carcinoma (HCC) have an unmet need for new therapies that improve survival. This phase II trial investigated the efficacy and safety of ociperlimab and tislelizumab plus BAT1706 (a bevacizumab biosimilar) in patients with first-line HCC.</p><p><strong>Methods: </strong>In this phase II, multicenter, randomized, multi-arm, open-label trial, patients with advanced HCC received ociperlimab and tislelizumab plus BAT1706 (Arm A) or tislelizumab plus BAT1706 (Arm B). The primary objective was to evaluate efficacy using objective response rate (ORR) assessed by the investigator per RESIST v1.1 for Arms A and B.</p><p><strong>Results: </strong>94 patients were randomized to Arm A (N = 62) and Arm B (N = 32). Confirmed ORR (95% confidence interval) was 37.1% (25.2-50.3) for Arm A and 40.6% (23.7-59.4) for Arm B. In Arms A and B, respectively, 90.3% and 80.6% of patients experienced treatment-related treatment-emergent adverse events (TEAEs), 59.7% and 32.3% experienced Grade ≥ 3 treatment-related TEAEs and 22.6% and 9.7% experienced treatment-related TEAEs leading to treatment discontinuation. Immune-mediated adverse events were reported in 50.0% of patients in Arm A and 45.2% of patients in Arm B. Infusion-related reactions occurred in a single patient in Arm A.</p><p><strong>Conclusion: </strong>In patients with advanced HCC, tislelizumab plus BAT1706 demonstrated promising ORR, while adding ociperlimab was not associated with improved efficacy. The safety profile of ociperlimab and tislelizumab plus BAT1706 was tolerable and manageable, with no new safety signals identified.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov: NCT04948697 (September 20, 2021).</p>\",\"PeriodicalId\":520581,\"journal\":{\"name\":\"Cancer immunology, immunotherapy : CII\",\"volume\":\"75 5\",\"pages\":\"\"},\"PeriodicalIF\":5.1000,\"publicationDate\":\"2026-04-28\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13125556/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Cancer immunology, immunotherapy : CII\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1007/s00262-026-04399-8\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cancer immunology, immunotherapy : CII","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1007/s00262-026-04399-8","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
AdvanTIG-206: a phase II, randomized study of ociperlimab plus tislelizumab and BAT1706 (bevacizumab biosimilar) versus tislelizumab and BAT1706 in first-line hepatocellular carcinoma.
Background: Patients with hepatocellular carcinoma (HCC) have an unmet need for new therapies that improve survival. This phase II trial investigated the efficacy and safety of ociperlimab and tislelizumab plus BAT1706 (a bevacizumab biosimilar) in patients with first-line HCC.
Methods: In this phase II, multicenter, randomized, multi-arm, open-label trial, patients with advanced HCC received ociperlimab and tislelizumab plus BAT1706 (Arm A) or tislelizumab plus BAT1706 (Arm B). The primary objective was to evaluate efficacy using objective response rate (ORR) assessed by the investigator per RESIST v1.1 for Arms A and B.
Results: 94 patients were randomized to Arm A (N = 62) and Arm B (N = 32). Confirmed ORR (95% confidence interval) was 37.1% (25.2-50.3) for Arm A and 40.6% (23.7-59.4) for Arm B. In Arms A and B, respectively, 90.3% and 80.6% of patients experienced treatment-related treatment-emergent adverse events (TEAEs), 59.7% and 32.3% experienced Grade ≥ 3 treatment-related TEAEs and 22.6% and 9.7% experienced treatment-related TEAEs leading to treatment discontinuation. Immune-mediated adverse events were reported in 50.0% of patients in Arm A and 45.2% of patients in Arm B. Infusion-related reactions occurred in a single patient in Arm A.
Conclusion: In patients with advanced HCC, tislelizumab plus BAT1706 demonstrated promising ORR, while adding ociperlimab was not associated with improved efficacy. The safety profile of ociperlimab and tislelizumab plus BAT1706 was tolerable and manageable, with no new safety signals identified.
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