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251 Efficacy and safety of iparomlimab and tuvonralimab in previously treated patients with recurrent or metastatic cervical cancer: a multicenter, open-label, single-arm, phase 2 clinical trial (DUBHE-C-206)
  1. Hanmei Lou1,
  2. Yun Zhou2,
  3. Dapeng Li3,
  4. Hongping Zhang4,
  5. Mingjun Zhang5,
  6. Lihua Wang6,
  7. Huijun Cheng7,
  8. Zi Liu8,
  9. Wei Duan9,
  10. Mei Feng10,
  11. Chao Wang11,
  12. Shilin Xue11,
  13. Hui Li11,
  14. Xiaoyan Kang11 and
  15. Jihong Liu2
  1. 1Zhejiang Cancer Hospital, Hangzhou, China
  2. 2Sun Yat-sen University Cancer Center, Guangzhou, China
  3. 3Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China
  4. 4The Third Affiliated Hospital of Kunming Medical University, Yunnan Cancer Hospital, Yunnan Cancer Center, Kunming, China
  5. 5The Second Affiliated Hospital of Anhui Medical University, Hefei, China
  6. 6The First Affiliated Hospital of Bengbu Medical College, Bengbu, China
  7. 7Henan Cancer Hospital, Zhengzhou, China
  8. 8The First Affiliated Hospital of Xi’an Jiaotong University, Xi’An, China
  9. 9Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China
  10. 10Fujian Provincial Cancer Hospital, Fuzhou, China
  11. 11Clinical Research Centre, Qilu Pharmaceutical, Jinan, China


Introduction/Background Iparomlimab and tuvonralimab (QL1706), a bifunctional PD-1/CTLA-4 dual blocker, showed preliminary efficacy in patients with cervical cancer in phase 1 trial.

Methodology This multi-center, open-label, single-arm, phase 2 trial (NCT05557565) recruited immune checkpoint inhibitors naïve patients with recurrent or metastatic cervical cancer (r/m CC) who failed first-line platinum-based chemotherapy with or without bevacizumab, regardless of PD-L1 status. Intravenous injection of iparomlimab and tuvonralimab 5.0 mg/kg every three weeks was administered. The primary endpoint was objective response rate (ORR) evaluated by the independent review committee (IRC).

Results As of April 28, 2023, 148 participants were included in the full analysis set. Eastern Cooperative Oncology Group Performance Status scored 1 in 109 (73.6%) patients. Fifty-nine (39.9%) patients received prior bevacizumab. Fifty-five patients (37.2%) had received ≥2 lines of prior treatment. Median follow-up was 11.0 (0.7, 15.5) months. Per IRC, ORR was 33.8% (95% confidence interval [CI]: 26.2%-42.0%), and disease control rate was 64.9% (95% CI: 56.6%-72.5%). Median progression-free survival achieved 5.4 month (95% CI: 3.9–6.9). Median overall survival was not reached. ORR was 25.6% (95% CI: 13.5–41.2) and 37.1% (95% CI: 27.9%-47.1%) in patients with combined positive score (CPS) <1 (n=43) and with CPS≥1 (n=105), respectively. Treatment-related adverse events (TRAE) occurred in 104 (70.3%) patients. TRAE of grade ≥3 occurred in 36 (24.3%) patients, and the most common were anemia (4.1%), gamma-glutamyl transferase increased (2.7%), and lipase increased (2.7%). Three (2.0%) participants had TRAE leading to treatment discontinuation. Nine (6.1%) participants died due to treatment-emergent adverse events, which were all unrelated to the treatment.

Conclusion Iparomlimab and tuvonralimab showed promising efficacy and manageable safety in patients with r/m CC who failed first-line chemotherapy. A phase 3 trial (NCT05446883) evaluating iparomlimab and tuvonralimab plus chemotherapy as first-line treatment for r/m CC is ongoing.

Disclosures The presenting author, Jihong Liu, and the co-authors Hanmei Lou, Yun Zhou, Dapeng Li, Hongping Zhang, Mingjun Zhang, Lihua Wang, Huijun Cheng, Zi Liu, Wei Duan, and Mei Feng, declare that they have no conflict of interest. The co-authors Chao Wang, Shilin Xue, Hui Li, and Xiaoyan Kang are full-time employees of the company Qilu Pharmaceutical Co., Ltd.

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