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On February 27 local time, at the 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO-GU) held in San Francisco, USA, the latest efficacy and safety data from the extended follow-up of the phase II clinical study (RC48-C017) of Rongchang Bio's disitamab vedotin combined with toripalimab as neoadjuvant therapy for HER2-expressing muscle-invasive bladder cancer (MIBC) were presented in the form of a poster. The results showed that this combination therapy demonstrated durable disease control and survival benefits during the neoadjuvant phase, with good safety, providing important reference for future clinical practice.
· Abstract Number: 766
· Neoadjuvant treatment with disitamab vedotin plus perioperative toripalimab in patients with HER2-expressing muscle-invasive bladder cancer (MIBC) in the phase II RC48-C017 trial: updated results
· Updated data from the RC48-C017 study: A phase II clinical trial of neoadjuvant disitamab vedotin combined with perioperative toripalimab for HER2-expressing muscle-invasive bladder cancer
· Subsession Title: Poster Subsession B - Prostate Cancer and Urothelial Carcinoma
· First Author and Poster Presenter: Professor Sheng Xinan, Peking University Cancer Hospital
· Corresponding Author: Professor Guo Jun, Peking University Cancer Hospital
The RC48-C017 study is an open-label, single-arm, multicenter phase II clinical trial conducted in China, with Professor Guo Jun from Peking University Cancer Hospital serving as the principal investigator. It aims to evaluate the efficacy and safety of disitamab vedotin combined with toripalimab in the perioperative treatment of MIBC patients, with the primary endpoint being the pathological complete response rate (pCR rate). This study is the first prospective clinical research globally to report results on the combination of an ADC and immunotherapy in the neoadjuvant treatment of MIBC. At the 2025 ASCO-GU conference, a pCR rate as high as 63.6% was announced.
As of August 14, 2025, the study had enrolled a total of 47 patients, of whom 33 underwent radical cystectomy + pelvic lymph node dissection (RC+PLND). The median overall survival (OS) follow-up time reached 26.4 months (95% CI: 24.4–28.2), and the study results showed:
· Event-free survival (EFS) performed excellently. Among surgical patients, the 12-month and 18-month EFS rates were 93.2% (95% CI: 75.4–98.3) and 80.9% (95% CI: 54.4–92.9), respectively; for all patients, the EFS rates were 91.0% (95% CI: 77.8–96.5) and 81.5% (95% CI: 64.3–90.9), respectively, with the median EFS not yet reached.
· Overall survival (OS) rates remained high. The median OS was not yet reached; the 12-month and 24-month OS rates were 95.7% (95% CI: 83.9–98.9) and 91.3% (95% CI: 78.6–96.7), respectively.
· Safety was maintained well. No new safety signals emerged, and adverse reactions were manageable.
Comprehensive analysis shows that the updated research data indicate that the combination of disitamab vedotin and toripalimab demonstrates sustained efficacy in perioperative treatment of HER2-expressing MIBC, further consolidating the therapeutic advantages of this combination regimen. The high pathological response rate achieved in initial treatment has translated into durable disease control and survival benefits, which is corroborated by its excellent EFS and OS outcomes, providing important references for future clinical practice.
The study of disitamab vedotin combined with toripalimab as first-line treatment for HER2-expressing advanced urothelial carcinoma (RC48-C016) has achieved breakthrough results, and a domestic marketing application has been submitted. The RC48-C017 study aims to further explore and validate the efficacy and safety of this "precision targeting + immune activation" combination therapy in the neoadjuvant treatment of MIBC patients. Based on the RC48-C017 study, disitamab vedotin was included in the list of breakthrough therapy drugs by the Center for Drug Evaluation (CDE) of the National Medical Products Administration in May 2024.
