ASCO GU｜RemeGen Announced Highly Encouraging Data from the Phase II Clinical Trial Evaluating Disitamab Vedotin plus Immunotherapy as Perioperative Regimen for Bladder Cancer USA - English APAC - Traditional Chinese
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YANTAI, China, Feb. 15, 2025 ~ At the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) in San Francisco, USA, Professor Xinan Sheng from Peking University Cancer Hospital presented the latest data from a phase II clinical trial of Disitamab Vedotin (DV) in combination with Toripalimab as a neoadjuvant therapy for HER2-expressing muscle-invasive bladder cancer (MIBC). This marks the first time that results from a prospective clinical study investigating an ADC drug in combination with an immunotherapy have been publicly disclosed.

The study, known as NCT05297552 and identified as Study ID: RC48-C017, explored the potential synergy between targeted therapy and immunotherapy in the perioperative setting for MIBC. It specifically evaluated the safety and efficacy of combining DV, a HER2-targeting ADC drug developed by RemeGen Co., Ltd. (RemeGen), with Toripalimab, a PD-1 inhibitor.

In May 2024, based on the preliminary results of this study, China's National Medical Products Administration (NMPA) granted breakthrough therapy designation to DV. These initial findings were also presented at the 2024 ASCO Annual Meeting and generated significant interest among experts worldwide. The updated data presented at ASCO GU further confirmed the promising clinical benefits of this therapeutic approach.

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The NCT05297552 study included 47 eligible patients, with 10.6% having HER2 IHC 1+, 57.4% having IHC 2+, and 31.9% having IHC 3+. Of these patients, 33 underwent radical cystectomy and pelvic lymph node dissection (RC + PLND). As of December 3, 2024, when the data was cut off, the study showed impressive efficacy and manageable safety profiles:

- The pathological complete response (pCR) rate was 63.6%, nearly double that of traditional neoadjuvant chemotherapies (36%-42%). The overall pathological response rate was 75.8%. Notably, for patients with a baseline clinical stage of T2N0, the postoperative pCR rate reached 85.7%. Additionally, a pCR rate of 55.6% was achieved in patients with other pathological subtypes of urothelial carcinoma at baseline. These results were consistent regardless of PD-L1 status or HER2 expression level (IHC 1+/2+/3+), with a pCR rate of 84.6% observed in patients with HER2 IHC 3+.

- The 12-month event-free survival (EFS) rate for all patients who underwent radical cystectomy was 92.5%, and the 18-month EFS rate was 85.9%.

- The therapy demonstrated a manageable safety profile, with only 27.7% of patients experiencing grade 3 or higher treatment-emergent adverse events (TEAEs). This is significantly lower than the incidence seen with traditional chemotherapy regimens (40%-50%), indicating a favorable tolerability.

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RemeGen is committed to advancing research on targeted and personalized therapies for bladder cancer through expanding indications and innovating new therapies using DV. The company aims to provide more potent treatment options for bladder cancer patients worldwide. Currently, studies are underway to explore the feasibility of using DV-based regimens as first-line treatment for locally advanced or metastatic urothelial cancer. There are also plans to expand research on DV as a neoadjuvant therapy for MIBC throughout the entire perioperative period and investigate its potential synergy with chemotherapy or other immunotherapies in treating urothelial cancer.

ASCO GU is one of the top conferences in urologic oncology, attracting leading experts from around the world. The presentation of the NCT05297552 study results at this prestigious event highlights the significance and potential impact of this novel combination therapy for MIBC. With further research and development, DV in combination with Toripalimab could potentially revolutionize the treatment landscape for HER2-expressing MIBC.
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