YANTAI, China, March 10, 2024 /PRNewswire/ -- RemeGen Co. Ltd.("RemeGen" or "the Company") (9995.HK, 688331.SH), a commercial-stage biotechnology company, recently gave an oral presentation on an interim analysis of the evaluation of the Company's proprietary Disitamab Vedotin (RC48), an investigational anti-HER2 antibody-drug conjugate (ADC) targeting prevalent solid tumor cancers with significant unmet medical needs, at the European Congress on Gynaecological Oncology (ESGO 2024 Congress) held in Barcelona from March 7-10, 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 malignanciesHER2-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 cancerHER2-expressing r/m cervical cancer patients, suggesting it to be a promising new treatment for HER2-expressed cervical cancer.
Dr. Jianmin Fang, CEO of RemeGen, commented, "ESGO congress is a unique opportunity for professionals from around the world to share and discuss their latest medical and scientific developments in their gynecological cancers research, treatment, and care. I am delighted to share an oral presentation on the evaluation of our proprietary ADC Disitamab Vedotin at ESGO 2024. It marks RemeGen's commitment to continued innovation and advancement in the field of cervical cancer treatment, and we strongly believe that the results of RC48 will bring new hope to cervical cancer patients."
Founded in 2008, RemeGen (9995.HK, SHA: 688331) is a leading biopharmaceutical company in China committed to providing solutions to the unmet clinical needs of patients suffering from life-threatening illnesses. RemeGen has research laboratories and offices throughout China and the United States. The company is committed to discovering, developing, and commercializing innovative and differentiated biologic drugs of significant clinical value in the key therapeutic areas of autoimmune, oncology, and ophthalmic diseases.
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