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342 Evaluation of the effectiveness and safety of disitamab vedotin for HER2-expressing recurrent cervical cancer after progression on platinum-based treatment-a single-arm, multicenter, open-label, phase II clinical study
  1. Lingying Wu1,
  2. Guiling Li2,
  3. Youzhong Zhang3,
  4. Ruifang An4,
  5. Li Sun5,
  6. Keqiang Zhang6,
  7. Yi Huang7,
  8. Ruixia Guo8,
  9. Qingshui Li9,
  10. Jinwei Miao10,
  11. An Lin11,
  12. Jianlin Yuan12,
  13. Ge Lou13,
  14. Hongying Yang14,
  15. Yu Zhang15,
  16. Hui Zhang16,
  17. Aiqin He17,
  18. Junying Tang18,
  19. Jianming Ying1,
  20. Yun Ling1 and
  21. Jianmin Fang19
  1. 1Department of Gynecologic Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
  2. 2Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
  3. 3Qilu Hospital of Shandong University, Jinan, China
  4. 4The First Affiliated Hospital of Xi ‘an Jiaotong University, Xian, China
  5. 5Cancer Hospital, Chinese Academy of Medical Sciences, Shenzhen Center, Shenzhen, China
  6. 6Hunan Cancer Hospital, Changsha, China
  7. 7Hubei Cancer Hospital, Wuhan, China
  8. 8The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China
  9. 9Shandong Cancer Hospital, Jinan, China
  10. 10Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China
  11. 11Fujian Cancer Hospital, Fuzhou, China
  12. 12Affiliated Cancer Hospital of Xinjiang Medical University, Xinjiang, China
  13. 13Harbin Medical University Cancer Hospital, Harbin, China
  14. 14Yunnan Cancer Hospital, Kunming, China
  15. 15Xiangya Hospital, Central South University, Changsha, China
  16. 16The Fourth Hospital of Hebei Medical University, Shijiazhuang, China
  17. 17Nantong Tumor Hospital, Nantong, China
  18. 18The First Affiliated Hospital of Chongqing Medical University, Chongqing, China
  19. 19College of Life Science and Technology, Tongji University, Shanghai, China


Introduction/Background Disitamab Vedotin (RC48) is a HER2-targeted ADC. A phase II, open-label, multicenter basket design study (NCT04965519) is currently underway to evaluate the effectiveness and safety of RC48 monotherapy in the treatment of HER2-expressing gynecologic malignancies.

Methodology The cervical cancer cohort includes patients with recurrent or metastatic cervical cancer who have progressed on at least 1L anti-tumor therapy and have HER2 IHC ≥1+. The treatment regimen consists of RC48 monotherapy administered at a dose of 2 mg/kg Q2W. The primary endpoint is the ORR(IRC). Secondary endpoints include ORR(INV), DoR, DCR, PFS, OS, and safety.

Results From January 24, 2022, to April 30, 2023, 17 cervical cancer patients were enrolled. The median age was 53 years (range: 35–66). Most patients (58.8%) had a baseline ECOG performance score of 1. Ten patients had a primary FIGO stage of IIB or higher. 13(76.5%) patients had squamous cell carcinoma, and 4 (23.5%) had adenocarcinoma. Among the 16 efficacy evaluable patients, the cORR was 43.8% (7/16), the mDoR was 5.45 months, and the median time to response was 1.5 months. The DCR was 87.5% (14/16), and the mPFS was 4.17 months . Among all 17 cervical cancer patients, the most common treatment-related adverse events (TRAEs) included decreased white blood cell count (53%), anemia (53%), increased aspartate aminotransferase (47%). Grade 3 or higher TRAEs included decreased neutrophil count (16%), increased gamma-glutamyl transferase (11%). Two patients (11.8%) experienced SAEs, and there were no deaths related to RC48.

Conclusion RC48 demonstrates manageable safety profile and positive efficacy in HER2-expressing r/m cervical cancer patients, suggesting it a promising new treatment for HER2- expressed cervical cancer.

Disclosures This trial is sponsored by RemeGen Co., Ltd. All authors are investigators of this trial except Jianmin Fang. Jianmin Fang is the CEO of RemeGen Co., Ltd. COI are uploaded.

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