Ding Bo, Yu Tianxiang, Zheng Shiya, Xu Jingyun, Ji Feng, Lin Hao, Zhao Xiang, Qiu Shanhu, Shen Yang
Department of Obstetrics and Gynecology, Zhongda Hospital, School of Medicine, Southeast University, Nanjing 210009, China.
Nanjing Key Laboratory of Intelligent Obstetrics and Gynecology Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing 210009, China.
Oncologist. 2025 Sep 1;30(9). doi: 10.1093/oncolo/oyaf210.
Effective and tolerable treatment for patients with platinum-resistant recurrent ovarian cancer remains a great challenge in clinical practice. This study aimed to evaluate the efficacy and safety of envafolimab, the first subcutaneously administered programmed death ligand 1 (PD-L1) inhibitor, combined with lenvatinib and etoposide in patients with platinum-resistant recurrent ovarian cancer.
This was an open-label, single-arm, phase 2 trial (ENLEN-OC-001). Patients with platinum-resistant recurrent ovarian cancer were eligible for inclusion who were administered envafolimab subcutaneously on day 1 and lenvatinib and etoposide orally on days 1-14, with 21 days as a cycle. After 6-10 cycles, envafolimab and lenvatinib were taken as maintenance therapy until intolerable toxicity, disease progression, withdrawal of consent, or finishing 24 months of treatment. The primary endpoint was objective response rate (ORR), and the secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.
Of the screened 28 patients, 21 were included, with 18 being assessed for the efficacy and safety. The ORR was 44.4% (95% CI 21.5%-69.2%), and the DCR was 83.3% (95% CI 58.6%-96.4%). The median PFS was 10.2 months (95% CI 5.6-not applicable [NA]), and the median OS was 21.3 months (95% CI 6.8-NA). The most common grade 3/4 adverse events were leukopenia (27.8%) and thrombocytopenia (16.7%). No serious adverse events or treatment-related deaths were reported. No changes were observed in the depression, anxiety, and quality of life following treatment.
Envafolimab combined with lenvatinib and etoposide showed promising efficacy and tolerable safety for patients with platinum-resistant recurrent ovarian cancer.
CLINICALTRIALS.GOV IDENTIFIER: NCT05422183.
对于铂耐药复发性卵巢癌患者，有效且耐受性良好的治疗在临床实践中仍然是一项巨大挑战。本研究旨在评估恩沃利单抗（首个皮下注射的程序性死亡配体1（PD-L1）抑制剂）联合乐伐替尼和依托泊苷治疗铂耐药复发性卵巢癌患者的疗效和安全性。
这是一项开放标签、单臂、2期试验（ENLEN-OC-001）。铂耐药复发性卵巢癌患者符合纳入标准，于第1天皮下注射恩沃利单抗，第1 - 14天口服乐伐替尼和依托泊苷，每21天为一个周期。6 - 10个周期后，恩沃利单抗和乐伐替尼作为维持治疗，直至出现不可耐受的毒性、疾病进展、撤回同意或完成24个月的治疗。主要终点为客观缓解率（ORR），次要终点包括疾病控制率（DCR）、无进展生存期（PFS）、总生存期（OS）和安全性。
在筛选的28例患者中，纳入21例，其中18例接受了疗效和安全性评估。ORR为44.4%（95%CI 21.5% - 69.2%），DCR为83.3%（95%CI 58.6% - 96.4%）。中位PFS为10.2个月（95%CI 5.6 - 不可用[NA]），中位OS为21.3个月（95%CI 6.8 - NA）。最常见的3/4级不良事件为白细胞减少（27.8%）和血小板减少（16.7%）。未报告严重不良事件或与治疗相关的死亡。治疗后抑郁、焦虑和生活质量未见变化。
恩沃利单抗联合乐伐替尼和依托泊苷对铂耐药复发性卵巢癌患者显示出有前景的疗效和可耐受的安全性。
NCT05422183。
