Abstract PS3-08: Interim Overall Survival of Patients with Locally Advanced or Metastatic Triple-Negative Breast Cancer treated with First Line PM8002/BNT327 in Combination with Nab-Paclitaxel in Phase Ib/II Study

作者：Jiong Wu, Jian Zhang, Zhongsheng Tong, Qingyuan Zhang, Yongsheng Wang, Qiao Cheng, Xin Chen, Zhihua Li, Yongmei Yin, Yiqun Du, Yanchun Meng · 发表于：Clinical Cancer Research · 年份：2025 · DOI：10.1158/1557-3265.sabcs24-ps3-08 · 被引用次数：4 · 研究领域：Cancer Treatment and Pharmacology、Advanced Breast Cancer Therapies、PARP inhibition in cancer therapy

Abstract Background: PD-L1 and VEGF play important roles in immune evasion and tumoral angiogenesis, promoting cancer growth and metastasis. PM8002/BNT327 is an investigational bispecific antibody targeting PD-L1 and VEGF-A, in development for the treatment of solid tumors. We conducted a Phase Ib/II study of PM8002/BNT327 in combination with nab-paclitaxel in pts with locally advanced or metastatic triple-negative breast cancer (LA/mTNBC) in China. We provide updated results including interim overall survival (OS) since initial reports at SABCS 2023 and ESMO 2024. Methods: 42 Pts with previously untreated LA/mTNBC were enrolled till 11 Apr 2023 to assess the safety and efficacy of PM8002/BNT327 in combination with nab-paclitaxel. All patients received PM8002 at 20 mg/kg (Q2W) and nab-paclitaxel at 100 mg/m2 on the 1st, 8th, and 15th day of each 28-day cycle until unacceptable toxicity or disease progression were observed. Efficacy was assessed every 8 weeks. Primary objectives were safety per CTCAE 5.0 and objective response rate (ORR) per RECIST v1.1 by investigator assessment, with progression free survival (PFS) and overall survival (OS) as secondary objectives. Results: As of 13th Sep 2024, with a median follow-up time of 18.1 months (95% CI 16.9, 19.7), median duration of treatment was 10.0 months (range 2.0-22.0) with 9/42 patients still on treatment. The confirmed ORR (cORR) was 73.8% with a disease control rate (DCR) of 95.2%. The median time to response (TTR) was 1....