RemeGen Presents Oral Presentation on Evaluation of Its Proprietary Disitamab Vedotin (RC48) for Cervical Cancer at ESGO 2024
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. 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 objective response rate (ORR) by Independent Review Committee, with secondary endpoints including ORR by Investigator, duration of response (DoR), disease control rate (DCR), progression free survival (PFS), overall survival (OS), and safety.
As of October 31, 2023, 25 patients with cervical cancer were enrolled with a median age of 56 years (range: 35-66). Most patients (64%) had a baseline ECOG performance score of 1. 18 patients had a primary FIGO stage of IIB or higher. 16 (64%) patients had squamous cell carcinoma, and 9 (36%) had adenocarcinoma. Among the 22 efficacy evaluable patients,
- The ORR was 36.4% (8/22). The confirmed ORR was 31.8% (7/22), the DCR was 86.4% (19/22), and the median time to response was 1.5 months.
- The mDoR was 5.52 months, and the mPFS was 4.37 months.
The most common treatment-related adverse events (TRAEs) included an increase in ALT (56%), an increase in AST (56%), and a decrease in white blood cell count (52%). Two patients (8%) experienced SAEs, and there were no deaths related to RC48. In conclusion, RC48 demonstrates a manageable safety profile and positive efficacy in HER2-expressing r/m cervical cancer patients, suggesting it to be a promising new treatment for HER2-expressed cervical cancer.
Dr. Jianmin Fang, CEO of
Cervical cancer is one of the most common gynecological malignancies, with the latest cancer report in
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About Disitamab Vedotin (RC48)
Disitamab Vedotin (RC48) is an investigational anti-HER2 antibody-drug conjugate targeting prevalent solid cancers with significant unmet medical needs and is the first domestically developed ADC to receive marketing approval in China. The drug was granted conditional marketing approval in June 2021 by the
The company is implementing a differentiated development and commercial strategy for disitamab vedotin, including (i) gastric cancer (GC), (ii) urothelial carcinoma (UC), (iii) breast cancer (BC), and (iv) other HER2-expressing cancers.
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