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  • LB011/#1557  Benmelstobart (TQB2450) alone or combined with anlotinib in previously treated advanced endometrial cancer: updated results from a multicohort, open-label, multicenter phase II clinical trial TQB2450-II-08

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Late-Breaking Abstracts
AS04. Endometrial/Uterine corpus cancers
LB011/#1557  Benmelstobart (TQB2450) alone or combined with anlotinib in previously treated advanced endometrial cancer: updated results from a multicohort, open-label, multicenter phase II clinical trial TQB2450-II-08
  1. Xiaohua Wu1,
  2. Xiaojun Chen2,
  3. Xuezhen Luo3,
  4. Ke Wang4,
  5. Dong Wang5,
  6. Ruifang An6,
  7. Jianqing Hou7,
  8. Ying Yang7,
  9. Danbo Wang8,
  10. Pengpeng Qu9,
  11. Bingzhong Zhang10,
  12. Wei Duan11,
  13. Xiumin Li12,
  14. Aimin Zang13,
  15. Guohua Yu14,
  16. Hanmei Lou15,
  17. Desheng Yao16,
  18. Shuzhen Wang17,
  19. Dong Yan18,
  20. Liang Li19,
  21. Xiaowei Liu20,
  22. Weidong Zhao21,
  23. Zhengzheng Chen21,
  24. Jing Fei22,
  25. Jundong Li23,
  26. Jing Wang24,
  27. Zhilian Wang25,
  28. Shuzhong Yao26,
  29. Fangling Ning27,
  30. Huaijun Zhou28,
  31. Li Sun29,
  32. Lingya Pan30,
  33. Qing Liu31,
  34. Haihua Yang32,
  35. Li Wang33,
  36. Mingjun Zhang34,
  37. Xiaoxiang Chen35,
  38. Jianlin Yuan36,
  39. Xinwen Zhang37,
  40. Youzhong Zhang38 and
  41. Qinping Liao39
  1. 1Fudan University Shanghai Cancer Center, Shanghai, China
  2. 2Shanghai Tenth People’s Hospital, Shanghai, China
  3. 3Obstetrics & Gynecology Hospital of Fudan University, Shanghai, China
  4. 4Tianjin Cancer Hospital, Tianjin, China
  5. 5Chongqing University Cancer Hospital, Chongqing, China
  6. 6First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, China
  7. 7Yantai Yuhuangding Hospital, yantai, China
  8. 8Liaoning Cancer Hospital & Institute, Shenyang, China
  9. 9Tianjin Central Hospital of Gynecology Obstetrics, Tianjin, China
  10. 10Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China
  11. 11Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China
  12. 12Linyi Cancer Hospital, Linyi, China
  13. 13Affiliated Hospital of Hebei University, Baoding, China
  14. 14Weifang People’s Hospital, Weifang, China
  15. 15Zhejiang Cancer hospital, Hangzhou, China
  16. 16Guangxi Medical University Cancer Hospital, Nanning, China
  17. 17Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China
  18. 18Beijing Luhe Hospital, Capital Medical University, Beijing, China
  19. 19Meizhou People’s Hospital, Meizhou, China
  20. 20Affiliated Hospital of Jining Medical University, Jining, China
  21. 21The First Affiliated Hospital of USTC, Anhui Provincial Hospital, Hefei, China
  22. 22The First Affiliated Hospital of Shihezi University School of Medicine, Shihezi, China
  23. 23Sun Yat-Sen University Cancer Center, Guangzhou, China
  24. 24Hunan Cancer Hospital, Changsha, China
  25. 25Second hospital of Shanxi Medical University, Taiyuan, China
  26. 26The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China
  27. 27Binzhou Medical University Hospital, Binzhou, China
  28. 28Nanjing Drum Tower Hospital, Nanjing, China
  29. 29Qingdao Central Medical Group, Qingdao, China
  30. 30Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
  31. 31Gansu Provincial Maternity and Child-care Hospital, Lanzhou, China
  32. 32Taizhou Hospital of Zhejiang Province, Taizhou, China
  33. 33Henan Cancer Hospital, Zhengzhou, China
  34. 34The Second Hospital of Anhui Medical University, Hefei, China
  35. 35Jiangsu Cancer Hospital, Nanjing, China
  36. 36Affiliated Tumor Hospital of Xinjiang Medical University, Urumqi, China
  37. 37Xi’an People Hospital (Xi’an Fourth Hospital), Xi’an, China
  38. 38Qilu Hospital of Shandong University, Jinan, China
  39. 39Beijing Tsinghua Changgung Hospital, Beijing, China

Abstract

Introduction The TQB2450-II-08 (NCT04574284) study aims to evaluate the efficacy and safety of benmelstobart alone or combined with anlotinib in patients with advanced Endometrial Cancer (EC). Here, we reported the updated safety and efficacy data for stage 2 of cohort 1.

Methods Patients with pathologically confirmed advanced, recurrent or metastatic EC failed at 1 or 2 prior lines of platinum-based chemotherapy were enrolled. In cohort 1, non-MSI-H/dMMR patients received benmelstobart (1200 mg IV D1/Q3W) + anlotinib (12 mg PO QD D1-14/Q3W) until disease progression or intolerable toxicity. Cohort 1 was carried out in 2 stages. The study would progress to stage 2 if 8 or more of the 22 patients achieved CR/PR in stage 1. Additional 85 patients would be enrolled in stage 2. The primary endpoint was ORR by IRC. The secondary endpoints included ORR by investigator, DCR, DoR, PFS, OS and safety.

Results At data cutoff (May 9, 2024), 85 patients were enrolled in stage 2 of cohort 1 (22 patients in stage 1 with 8 achieved PR), the median age was 60.0 years, 80.0% were endometrioid carcinoma. The confirmed ORR by IRC was 34.12%. The mPFS and mOS was 8.80 months (95%CI 5.75, 15.18) and 21.78 months (95%CI 19.48, 29.14). The safety analysis includes all patients of cohort 1 (n=107). The most common any-grade TEAEs were hypertension, hypothyroidism and weight loss. The incidence of grade ≥3 TEAEs were 77.57%.

Conclusion/Implications Benmelstobart plus anlotinib showed promising antitumor activity with a manageable safety profile in the treatment of recurrent or metastatic EC.

https://doi.org/10.1136/ijgc-2024-IGCS.6

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