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

医学 内科学 宫颈癌 临床终点 肿瘤科 临床研究阶段 养生 贫血 不利影响 癌症 胃肠病学 外科 化疗 临床试验
作者
Lingying Wu,Guiling Li,Youzhong Zhang,Ruifang An,Li Sun,Keqiang Zhang,Yi Huang,Ruixia Guo,Qingshui Li,Jinwei Miao,Lin An,Jianlin Yuan,Ge Lou,Hongying Yang,Yu Zhang,Hui Zhang,Aiqin He,Junying Tang,Jianming Ying,Yun Ling,Jianmin Fang
标识
DOI:10.1136/ijgc-2024-esgo.10
摘要

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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