和黄医药启动现正进行中的索凡替尼联合卡瑞利珠单抗用于治疗初治胰腺导管腺癌研究的III期阶段

Core Viewpoint - The company announced the initiation of a Phase III portion of a clinical trial for surufatinib in combination with camrelizumab, nab-paclitaxel, and gemcitabine for first-line treatment of metastatic pancreatic ductal adenocarcinoma (PDAC) patients in China, with the first patient receiving treatment on December 30, 2025 [1] Group 1: Clinical Trial Details - The study is a multicenter, randomized, open-label, positive-controlled Phase II/III clinical trial aimed at evaluating the efficacy and safety of the S+C+AG regimen compared to the AG regimen in adult metastatic pancreatic cancer patients who have not previously received systemic anti-tumor treatment [2] - The Phase II portion included 62 patients, with plans to enroll approximately 400 additional patients in the Phase III portion [2] - The primary endpoint for the Phase III portion is overall survival (OS), while secondary endpoints include progression-free survival (PFS), objective response rate (ORR), duration of response (DoR), disease control rate (DCR), quality of life, and safety [2] Group 2: Phase II Results - The results of the Phase II portion were recently presented at the 2025 ESMO Asia Congress, with a median PFS follow-up time of 8.15 months [3] - The median PFS for the S+C+AG group was 7.20 months, compared to 5.52 months for the AG group, indicating a 50.1% reduction in the risk of disease progression or death (stratified hazard ratio [HR] 0.499, log-rank test p=0.0407) [3] - Other key efficacy endpoints showed similar benefits, including ORR (67.7% vs. 41.9%, p=0.0430) and DCR (93.5% vs. 71.0%, p=0.0149) [3] - Although overall survival data is not yet mature, a positive trend has been observed, with 9 events in the S+C+AG group (N=31) and 15 events in the AG group (N=31) [3] - The treatment demonstrated manageable safety characteristics, with 80.6% of patients in the S+C+AG group experiencing grade 3 or higher treatment-emergent adverse events (TEAEs), compared to 61.3% in the AG group [3]