344 - Nimotuzumab plus Concurrent Chemoradiotherapy for Locally Advanced Cervical Squamous Cell Carcinoma: Updated Follow-Up from the Randomized, Phase 3 CC3 Study
Presenter(s)
J. Wang1, P. Jiang1, A. Qu1, L. C. Wei2, L. Zou3, X. F. Li4, C. Wang5, X. Sun6, L. Ding7, X. Yuan8, H. Cheng9, D. Wu10, R. Cai11, R. Yin12, J. Zhang13, H. Qiu14, T. Wang15, K. Gao16, Y. Zhuo17, and Y. Zhang18; 1Department of Radiation Oncology, Peking University Third Hospital, Beijing, China, 2Department of Radiotherapy, The First Affiliated Hospital,the Air Force Medical University, Xi’an, China, 3Department of Radiation Oncology, The Second Hospital of Dalian Medical University, Dalian, China, 4Department of Radiation Oncology, Beijing Cancer Hospital, Beijing, China, 5Department of Gynecology, Liaoning Cancer Hospital & Institute, Shenyang, China, 6Department of Radiotherapy, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China, 7Department of Radiotherapy, Baotou Cancer Hospital, Baotou, China, 8Department of Oncology Chemoradiotherapy, Cangzhou Hospital Of integrated TCM-WM•Hebei, Cangzhou, China, 9The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, Henan, China, 10Department of Radiotherapy, Nanfang Hospital, Guangzhou, China, 11Department of Radiotherapy, Ruijin Hospital ,Shanghai Jiao tong University School of Medicine, Shanghai, China, 12Department of Oncology Chemoradiotherapy, West China Second University Hospital, Sichuan University, Chengdu, China, 13Gynecological radiotherapy, Shanxi Province Tumor Hospital, Taiyuan, China, 14Department of Oncology Chemoradiotherapy, Zhongnan Hospital of Wuhan University, Wuhan, China, 15Department of Radiation Oncology, The second norman bethune hospital of jilin university, Changchun, China, 16Gynecologic Oncology, Guangxi Medical University Cancer Hospital, Nanning, China, 17Department of Radiation Oncology, Zhangzhou Municipal Hospital of Fujian Province, Zhangzhou, China, 18Department of Radiation Oncology, Harbin Medical University Cancer Hospital, Harbin, China
Purpose/Objective(s): Cervical cancer is the second most common malignant tumor in women, the 5-year overall survival rate of patients with locally advanced cervical cancer (LACC) in stage IB3~?A is 24%~76.1%. Nimotuzumab is a highly humanized IgG1 monoclonal antibody, which has a good effect on the treatment of LACC. In the primary analysis of the phase 3 CC3 study, after a median follow-up of 12 months, nimotuzumab combination with CCRT in LACC patients showed improved ORR, prolonged PFS and good safety. Here, we report updated analyses.
Materials/Methods: CC3 (NCT04678791) is an ongoing phase 3 clinical trial evaluating the efficacy and safety of nimotuzumab in combination with CCRT in LACC patients. Patients with aged 18-75 years, histologically confirmed LASCC, staged IB3-IVA according to FIGO 2018, measurable primary tumor according to RECIST 1.1 criteria. The primary endpoint was 3-year progression-free survival (PFS) . Secondary endpoints were 3-year overall survival (OS), objective response rate (ORR), complete response rate (CR) , and safety (CTCAE v5.0). All patients were randomly allocated to Nimo group and control group. The regimens had released at 2024 ASCO .
Results: As of the data cutoff (February 19, 2025), median (range) follow-up was 37.75 vs. 37.36 months. The baseline characteristics were balanced between two groups. Compared to control group, Nimo group exhibited better ORR (90.14% vs. 81.25%, p=0.03). The mPFS and mOS were not reached in two groups, but with significant better PFS in Nimo group (p=0.04) as shown in Kaplan-Meier curves. The 2-year PFS rate was 90% vs. 88%, respectively. The 2-year OS rate was 95.0% vs. 95.5%. Univariate cox regression of PFS showed patients aged <65 years benefited more from this combination regimen (p=0.02).There was no difference in SAE between the two groups (P>0.05) and no new AEs occurred.
Conclusion: Nimotuzumab combined with CCRT in the treatment of LACC patients showed significant best of response improvement, better PFS, and safety was manageable.
Table1. PFS subgroup Cox Congression Analysis *P-Value is the test of interaction between treatment and each subgroup unadjusted for multiplicity.| Subgroup | Nimo+CCRT events/n(%) | CCRT events/n(%) | HR(95%CI) | P-Value* |
| Age (yrs) | 0.27 | |||
| <65 | 12/107(11.2) | 24/100(24.0) | 0.45(0.23,0.90) | 0.02 |
| =65 | 6/34(17.6) | 6/35(17.1) | 0.98(0.32,3.05) | 0.98 |
| Clinical stage | 0.53 | |||
| IIIC | 8/57(14.0) | 9/46(19.6) | 0.70(0.27,1.82) | 0.47 |
| IB3-IIIB, IVA | 10/84(11.9) | 21/89(23.6) | 0.47(0.22,1.00) | 0.05 |
| Tumor diameter (cm) | 0.54 | |||
| <4 | 2/42(4.8) | 6/45(13.3) | 0.34(0.07,1.67) | 0.18 |
| =4 | 16/99(16.2) | 24/90(26.7) | 0.58(0.31,1.09) | 0.09 |