RemeGen Presents Oral Presentation on Evaluation of Its Proprietary Disitamab Vedotin (RC48) for Cervical Cancer at ESGO 2024

Rhea-AI Summary

RemeGen Co. Ltd. presented positive interim data on Disitamab Vedotin for HER2-expressing cervical cancer patients at ESGO 2024 Congress. The Phase II study showed an ORR of 36.4% and a manageable safety profile. RC48 demonstrates promise as a new treatment option for HER2-expressed cervical cancer.

Positive

• Positive interim data presented at ESGO 2024 Congress on Disitamab Vedotin for HER2-expressing cervical cancer patients.
• Phase II study showed an ORR of 36.4% and a DCR of 86.4% with RC48 monotherapy.
• Treatment-related adverse events included an increase in ALT (56%), AST (56%), and a decrease in white blood cell count (52%).
• Dr. Jianmin Fang, CEO of RemeGen, highlighted the company's commitment to innovation in cervical cancer treatment.
• Cervical cancer is a prevalent gynecological malignancy with significant unmet medical needs.

Negative

• None.

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 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 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."

Cervical cancer is one of the most common gynecological malignancies, with the latest cancer report in China in 2022 showing the 5-year progression-free survival (PFS) rate of patients with late-stage recurrent or metastatic cervical cancer to be only about 15%. Current treatment options for patients with recurrent or metastatic cervical cancer are limited to immunotherapy and chemotherapy (ORR ranging from 14.6% to 26.8%), indicating there are significant unmet clinical needs.

About RemeGen Co. Ltd.

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.

For more details, please visit: www.remegen.com

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 National Medical Products Administration (NMPA) in China to treat locally advanced or metastatic gastric cancer. In the same month, the company submitted an Investigational New Drug (IND) application for the treatment of HER2-expressing advanced or metastatic urothelial carcinoma with disitamab vedotin. In 2021, RemeGen and Seagen Inc. (acquired by Pfizer in December 2023) entered into an exclusive worldwide licensing agreement to develop and commercialize disitamab vedotin.

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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SOURCE RemeGen Co., Ltd

FAQ

What is the objective response rate (ORR) in the Phase II study of Disitamab Vedotin (RC48) for HER2-expressing cervical cancer?

The ORR in the Phase II study was 36.4%.

What are the primary endpoints of the Phase II study (NCT04965519) for RC48 monotherapy in cervical cancer patients?

The primary endpoint is objective response rate (ORR) by Independent Review Committee.

What are the common treatment-related adverse events (TRAEs) associated with RC48 monotherapy?

Common TRAEs included an increase in ALT (56%), an increase in AST (56%), and a decrease in white blood cell count (52%).

Who is the CEO of RemeGen and what was their comment on the interim data presented at ESGO 2024 Congress?

Dr. Jianmin Fang is the CEO of RemeGen. He highlighted the company's commitment to innovation in cervical cancer treatment.

What is the significance of the results of RC48 for HER2-expressed cervical cancer patients?

RC48 demonstrates promise as a new treatment option for HER2-expressed cervical cancer.