Guangwen Yuan, Ge Lou, Jundong Li, Mei Xu, Xiaowei Liu, Danbo Wang, Keqiang Zhang, Tao Zhu, X. Li, Yi Huang, Wei Duan, Ke Wang, Qi Zhou, Guiling Li, CHEN Yang, Jiajing Zhang, Haolin Sun, Renhong Tang, Qingshui Li, Lingying Wu
), an antibody to vascular endothelial growth factor or placebo every 2 weeks, with chemotherapy (paclitaxel, topotecan or PEGylated liposomal doxorubicin). The primary endpoint was progression-free survival (PFS). The key secondary endpoint was overall survival (OS). Other secondary endpoints included objective response rate, disease control rate, duration of response, quality of life, safety, pharmacokinetics and antidrug antibodies. Between June 5, 2021 and October 11, 2024, 421 participants were randomized (49.4% and 49.4% previously exposed to antiangiogenic agents and poly(ADP-ribose) polymerase inhibitors, respectively). Median PFS was 5.5 and 2.7 months in the suvemcitug and placebo arms, respectively (hazard ratio: 0.46, 95% confidence interval (CI): 0.35-0.60, P < 0.001), meeting the primary endpoint. Median OS was 15.3 versus 14.0 months, respectively (hazard ratio: 0.77, 95% CI: 0.60-0.99, P = 0.03). Decreased neutrophil count and decreased white blood cell count were the most common grade ≥3 treatment-emergent adverse events (TEAEs) in the suvemcitug arm. No suvemcitug-related grade 5 TEAE occurred. In conclusion, the addition of suvemcitug to chemotherapy significantly improved PFS and OS, with tolerable toxicities.