Although first-line immunochemotherapy has improved prognosis for patients with advanced esophageal squamous cell carcinoma (ESCC), more effective strategies still require further investigation. This multi-center, phase II study (ClinicalTrials.gov NCT05013697) assessed the feasibility of benmelstobart (a novel PD-L1 inhibitor) plus anlotinib (multitargeted TKI) and chemotherapy in advanced or metastatic/recurrent ESCC. Eligible patients received 4–6 cycles (21-day) of benmelstobart (1200 mg), anlotinib (10 mg) plus paclitaxel (135 mg/m²)/cisplatin (60–75 mg/m²), then maintained with benmelstobart and anlotinib. Primary endpoint was progression-free survival (PFS) assessed according to RECIST v1.1. Secondary endpoints were tumor response, overall survival (OS), and safety assessed by adverse events (AEs). From September 2021 to November 2023, 50 patients were enrolled and received study treatment. With median follow-up of 23.7 months as of April 1, 2024, median PFS was 14.9 months (95% CI, 11.4-not estimable [NE]) and the 1-year PFS was 58.5% (95% CI, 41.9%–71.9%). Among 50 patients, confirmed objective response rate was 72.0% and disease control rate was 84.0%. Median duration of response of 36 responders was 16.2 months (95% CI, 10.2-NE). At the cutoff date, 31 patients remained alive; median OS was not reached (95% CI, 13.2 months-NE) with 1-year OS of 74.8% (95% CI, 59.8%–84.8%). Forty-six (92.0%) patients reported treatment-related AEs, with 37 (74.0%) were grade ≥3. Overall, benmelstobart plus anlotinib and chemotherapy showed promising efficacy and acceptable toxicity in advanced or metastatic/recurrent ESCC.

尽管一线免疫化疗改善了晚期食管鳞状细胞癌 （ESCC） 患者的预后，但更有效的策略仍需要进一步研究。这项多中心 II 期研究 （ClinicalTrials.gov NCT05013697） 评估了 benmelstobart （一种新型 PD-L1 抑制剂） 联合安罗替尼 （多靶点 TKI） 和化疗在晚期或转移性/复发性 ESCC 中的可行性。符合条件的患者接受 4-6 个周期（21 天）的 benmelstobart （1200 mg）、anlotinib （10 mg） 加紫杉醇 （135 mg/m²）/顺铂 （60-75 mg/m²），然后用 benmelstobart 和安罗替尼维持治疗。主要终点是根据 RECIST v1.1 评估的无进展生存期 （PFS）。次要终点是肿瘤反应、总生存期 （OS） 和通过不良事件 （AE） 评估的安全性。从 2021 年 9 月到 2023 年 11 月，共入组 50 例患者并接受研究治疗。截至 2024 年 4 月 1 日，中位随访时间为 23.7 个月，中位 PFS 为 14.9 个月（95% CI，11.4-不可估计 [NE]），1 年 PFS 为 58.5%（95% CI，41.9%-71.9%）。在 50 例患者中，确认客观缓解率为 72.0%，疾病控制率为 84.0%。36 名缓解者的中位缓解持续时间为 16.2 个月 （95% CI，10.2-NE）。在截止日期，31 名患者仍然存活;未达到中位 OS （95% CI，13.2 个月-NE），1 年 OS 为 74.8% （95% CI，59.8%-84.8%）。46 例 （92.0%） 患者报告了治疗相关 AE，其中 37 例 （74.0%） 为 ≥3 级。总体而言，benmelstobart 联合安罗替尼和化疗在晚期或转移性/复发性 ESCC 中显示出良好的疗效和可接受的毒性。