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LB014/#1671  Cadonilimab plus chemotherapy ± bevacizumab as 1L treatment for persistent, recurrent, or metastatic cervical cancer (R/M CC): a randomized, double-blind, placebo-controlled phase 3 study (Compassion-16)
  1. Xiaohua Wu1,
  2. Yang Sun2,
  3. Hongying Yang3,
  4. Jing Wang4,
  5. Hanmei Lou5,
  6. Dan Li6,
  7. Ke Wang7,
  8. Hui Zhang8,
  9. Tao Wu9,
  10. Yuzhi Li10,
  11. Chunyan Wang11,
  12. Guiling Li12,
  13. Yifeng Wang13,
  14. Dapeng Li14,
  15. Ying Tang15,
  16. Mei Pan16,
  17. Hongyi Cai17,
  18. Ting Liu18 and
  19. Michelle Xia18
  1. 1Fudan University Shanghai Cancer Center, Shanghai, China
  2. 2Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, Fuzhou, China
  3. 3Yunnan Cancer Hospital, Kunming, China
  4. 4Hunan Cancer Hospital, and the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China
  5. 5Zhejiang Cancer Hospital, Hangzhou, China
  6. 6The Affiliated Hospital of Southwest Medical University, Luzhou, China
  7. 7Tianjin Medical University Cancer Institute and Hospital, Tianjin, China
  8. 8The Fourth Hospital of Hebei Medical University, Shijiazhuang, China
  9. 9Changde First People’s Hospital, Changde, China
  10. 10The First Affiliated Hospital of Bengbu Medical University, Bengbu, China
  11. 11Liaoning Cancer Hospital and Institute, Shenyang, China
  12. 12Union Hospital Affiliated to Tongji Medical College, Wuhan, China
  13. 13Zhujiang Hospital of Southern Medical University, Guangzhou, China
  14. 14Cancer Hospital of Shandong First Medical University, Jinan, China
  15. 15Affiliated Cancer Hospital of Chongqing University, Chongqing, China
  16. 16Jiangxi Maternal and Child Health Hospital, Nanchang, China
  17. 17Gansu Provincial Hospital, Lanzhou, China
  18. 18Akeso Biopharma Inc., Zhongshan, China

Abstract

Introduction Cadonilimab has been approved by China’s NMPA for advanced CC as ≥2L treatment in 2022. Here we report the benefit of adding cadonilimab to chemotherapy ± bevacizumab in 1L R/M CC.

Methods In this randomized, double-blind, placebo-controlled phase 3 trial, 1L R/M CC pts were randomized 1:1 to receive cadonilimab (10mg/kg) or placebo Q3W plus platinum-based chemotherapy ± bevacizumab (15mg/kg) per investigator discretion. Randomization were stratified by the use of bevacizumab (yes/no) and prior CCRT (yes/no). The dual primary endpoints were PFS per RECIST v1.1 assessed by BICR and OS in the ITT population.

Results 445 pts were randomized to cadonilimab group (n=222) or placebo (n=223) group. The demographic and baseline characteristics were well balanced. 59.6% of pts used bevacizumab and 48.3% received previous CCRT. 116 pts (26.1%) had a PD-L1 CPS<1. As of DCO for the PFS interim analysis (IA) (Sep 4, 2023), the median follow-up time was 17.87 mo. Median PFS was significantly improved by cadonilimab (12.7 vs 8.1 mo, HR 0.62, p<0.0001). As of the DCO for the OS IA (Apr 30, 2024), with median follow-up time of 25.63 mo, median OS was significantly prolonged by cadonilimab (NE vs 22.8 mo, HR 0.64, p=0.0011). The Benefits with cadonilimab were consistent across all predefined subgroups. Grade ≥ 3 TEAEs occurred in 85.4% of pts in cadonilimab group and 80.4% in placebo group.

Conclusion/Implications Cadonilimab significantly improved PFS and OS with manageable safety profile in patients with 1L R/M CC, which may be a new treatment option for this population.

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