Enlonstobart in patients with PD-L1 positive recurrent/metastatic cervical cancer: Updated survival results of the phase II study.

• DOI: 10.1200/jco.2025.43.16_suppl.5522
• Publication Date: 2025-05-28T15:17:35Z
• Authors: Jing Zuo; Lingying Wu; Xiaofan Li; Mei Feng; Guiling Li; Rutie Yin; Xiumin Li; Shan Kang; Hongmei Sun; Shuqing Wei; Yunyan Zhang; Yili Wang; Hu Liu; Wei Wang; Li Sun; Zhitu Zhu; Daren Lin; Kui Jiang; Silong Xiang; Miao Niu

5522 Background: Enlonstobart is a PD-1 inhibitor that has demonstrated durable anti-tumor activity and acceptable safety in patients with PD-L1 positive recurrent/metastatic cervical cancer multicenter, single-arm, open-label, phase II study. At primary cutoff date (May 27, 2023), the overall survival (OS) was not reached. Here, we report results from pre-planned further follow-up (August 20, 2024). Methods: Eligible were ≥18 years old PD-L1-positive (combined score ≥ 1) who had progression during or after intolerance to first-line platinum-based therapy. A total of 107 received enlonstobart 240 mg every two weeks for up 24 months until disease progression, intolerable toxicities, other study discontinuation criteria met. updated date, analyses progression-free (PFS) OS full analysis set (FAS), which consisted all at least one dose treatment, per protocol (PPS), FAS available postbaseline tumor assessment conducted. Results: August 20 2024, median time 15.84 (range 0.4 ~ 35.6 months). In FAS, PFS 3.06 (95 % CI 2.23–6.90) months. The 19.38 14.95–25.40) estimated rate 68.14 %CI 58.20–76.19) 12 months, 50.78 40.46–60.20) 18 42.84 32.76–52.53) PPS, 3.81 2.63–7.49) 21.26 15.44–27.66) 71.53 61.48–79.40) 53.32 42.64–62.87) 44.98 34.50–54.89) Conclusions: monotherapy showed promising cancer, whose experienced Clinical trial information: NCT04886700 .