ASCO GU｜RemeGen Announced Highly Encouraging Data from the Phase II Clinical Trial Evaluating Disitamab Vedotin plus Immunotherapy as Perioperative Regimen for Bladder Cancer
RemeGen presented promising Phase II clinical trial results for Disitamab Vedotin (DV) combined with Toripalimab in treating HER2-expressing muscle-invasive bladder cancer (MIBC) at ASCO GU 2025. The study (NCT05297552) showed a pathological complete response (pCR) rate of 63.6%, nearly double the traditional neoadjuvant chemotherapies (36%-42%).
The trial included 47 patients, with 33 undergoing radical cystectomy. Key findings include: 75.8% pathological response rate, 85.7% pCR rate in T2N0 stage patients, and 84.6% pCR rate in HER2 IHC 3+ patients. The 12-month event-free survival rate was 92.5%, with 18-month rate at 85.9%. Grade 3 or higher adverse events were reported in 27.7% of cases, lower than traditional chemotherapy (40%-50%).
RemeGen ha presentato risultati promettenti di uno studio clinico di fase II per il Disitamab Vedotin (DV) combinato con Toripalimab nel trattamento del cancro della vescica muscolo-invasivo (MIBC) che esprime HER2, durante il congresso ASCO GU 2025. Lo studio (NCT05297552) ha mostrato un tasso di risposta patologica completa (pCR) del 63,6%, quasi il doppio rispetto alle tradizionali chemioterapie neoadiuvanti (36%-42%).
La sperimentazione ha coinvolto 47 pazienti, di cui 33 hanno subito una cistectomia radicale. I risultati chiave includono: tasso di risposta patologica del 75,8%, 85,7% di pCR nei pazienti in stadio T2N0 e 84,6% di pCR nei pazienti HER2 IHC 3+. Il tasso di sopravvivenza senza eventi a 12 mesi è stato del 92,5%, con un tasso a 18 mesi dell'85,9%. Eventi avversi di grado 3 o superiori sono stati riportati nel 27,7% dei casi, inferiore rispetto alla chemioterapia tradizionale (40%-50%).
RemeGen presentó resultados prometedores de un ensayo clínico de fase II para Disitamab Vedotin (DV) combinado con Toripalimab en el tratamiento del cáncer de vejiga músculo-invasivo (MIBC) que expresa HER2, en el ASCO GU 2025. El estudio (NCT05297552) mostró una tasa de respuesta patológica completa (pCR) del 63,6%, casi el doble de las quimioterapias neoadyuvantes tradicionales (36%-42%).
El ensayo incluyó a 47 pacientes, de los cuales 33 se sometieron a cistectomía radical. Los hallazgos clave incluyen: tasa de respuesta patológica del 75,8%, 85,7% de pCR en pacientes en estadio T2N0 y 84,6% de pCR en pacientes HER2 IHC 3+. La tasa de supervivencia libre de eventos a 12 meses fue del 92,5%, con una tasa a 18 meses del 85,9%. Se reportaron eventos adversos de grado 3 o superiores en el 27,7% de los casos, inferior a la quimioterapia tradicional (40%-50%).
RemeGen은 ASCO GU 2025에서 HER2를 발현하는 근육 침습성 방광암(MIBC) 치료를 위해 Disitamab Vedotin(DV)과 Toripalimab의 조합에 대한 유망한 2상 임상 시험 결과를 발표했습니다. 연구(NCT05297552)는 병리학적 완전 반응(pCR) 비율이 63.6%로, 전통적인 신보조 화학요법(36%-42%)의 거의 두 배에 달했습니다.
이 시험에는 47명의 환자가 포함되었으며, 그 중 33명이 근치적 방광 절제술을 받았습니다. 주요 발견 사항으로는 병리학적 반응 비율이 75.8%, T2N0 단계 환자의 pCR 비율이 85.7%, HER2 IHC 3+ 환자의 pCR 비율이 84.6%로 나타났습니다. 12개월 사건 없는 생존율은 92.5%였으며, 18개월 생존율은 85.9%였습니다. 3도 이상의 부작용은 27.7%의 사례에서 보고되었으며, 이는 전통적인 화학요법(40%-50%)보다 낮았습니다.
RemeGen a présenté des résultats prometteurs d'un essai clinique de phase II pour le Disitamab Vedotin (DV) combiné avec le Toripalimab dans le traitement du cancer de la vessie musculo-invasif (MIBC) exprimant HER2, lors de l'ASCO GU 2025. L'étude (NCT05297552) a montré un taux de réponse pathologique complète (pCR) de 63,6%, presque le double des chimiothérapies néoadjuvantes traditionnelles (36%-42%).
L'essai a inclus 47 patients, dont 33 ont subi une cystectomie radicale. Les résultats clés incluent : taux de réponse pathologique de 75,8%, 85,7% de pCR chez les patients au stade T2N0 et 84,6% de pCR chez les patients HER2 IHC 3+. Le taux de survie sans événement à 12 mois était de 92,5%, avec un taux de 85,9% à 18 mois. Des événements indésirables de grade 3 ou supérieur ont été rapportés dans 27,7% des cas, inférieur à la chimiothérapie traditionnelle (40%-50%).
RemeGen präsentierte vielversprechende Ergebnisse einer Phase-II-Studie für Disitamab Vedotin (DV) in Kombination mit Toripalimab zur Behandlung von HER2-exprimierendem muskelinvasivem Blasenkrebs (MIBC) auf dem ASCO GU 2025. Die Studie (NCT05297552) zeigte eine pathologische vollständige Ansprechrate (pCR) von 63,6%, fast doppelt so hoch wie bei traditionellen neoadjuvanten Chemotherapien (36%-42%).
Die Studie umfasste 47 Patienten, von denen 33 eine radikale Zystektomie durchführten. Zu den wichtigsten Ergebnissen gehören: 75,8% pathologische Ansprechrate, 85,7% pCR-Rate bei Patienten im Stadium T2N0 und 84,6% pCR-Rate bei HER2 IHC 3+ Patienten. Die 12-Monats-Ereignis-freie Überlebensrate betrug 92,5%, die 18-Monats-Rate lag bei 85,9%. In 27,7% der Fälle wurden Nebenwirkungen der Grad 3 oder höher berichtet, was niedriger ist als bei traditionellen Chemotherapien (40%-50%).
- Achieved 63.6% pCR rate, significantly higher than traditional treatments (36-42%)
- Strong 12-month event-free survival rate of 92.5%
- Lower adverse events (27.7%) compared to traditional chemotherapy (40-50%)
- Received breakthrough therapy designation from China's NMPA in May 2024
- Demonstrated efficacy across all HER2 expression levels (IHC 1+/2+/3+)
- None.
The NCT05297552 study explored the synergy between the targeted therapy and immunotherapy in the perioperative setting for MIBC. Specifically, it assessed the safety and efficacy of the novel combination therapy featuring DV, a HER2-targeting ADC drug initially developed by RemeGen Co., Ltd. (RemeGen), and Toripalimab, a PD-1 inhibitor. In May 2024, based on the NCT05297552 study, the Center for Drug Evaluation (CDE) of
In the NCT05297552 study, 47 eligible patients (
- The pathological complete response (pCR) rate reached an impressive
63.6% (95% CI:45.1% -79.6% ), nearly doubling that observed with traditional neoadjuvant chemotherapies (36% -42% ). The pathological response rate was75.8% (95% CI:57.7% -88.9% ). The study showed that for patients with baseline clinical stage of T2N0, the postoperative pCR rate reached85.7% . A pCR rate of55.6% was also achieved in patients with other pathological subtypes of urothelial carcinoma at baseline. Patients benefited significantly regardless of PD-L1 positive/negative and regardless of HER2 expression status (IHC 1+/2+/3+), among whom the pCR rate stood at84.6% for HER2 IHC 3+ patients. - The 12-month event-free survival (EFS) rate of all patients who underwent radical cystectomy was
92.5% , and the 18-month EFS rate was85.9% . - The therapy exhibited a manageable safety profile. The incidence of grade 3 or higher treatment-emergent adverse events (TEAEs) was only
27.7% , notably lower than the traditional chemotherapy regimen (40% -50% ), suggesting a favorable tolerability.
RemeGen is advancing research on targeted and personalized therapies for bladder cancer through indication expansion and therapy innovation of DV, aiming to provide more potent treatment options for patients worldwide. Currently, studies are in-progress to explore the feasibility of expanding DV-based regimens from later-line to front-line treatment for locally advanced or metastatic urothelial cancer. There are also plans to broaden the research of DV as a neoadjuvant therapy for MIBC to the entire perioperative period and investigate the synergy between DV and chemotherapy or other immunotherapies in treating urothelial cancer.
View original content to download multimedia:https://www.prnewswire.com/news-releases/asco-guremegen-announced-highly-encouraging-data-from-the-phase-ii-clinical-trial-evaluating-disitamab-vedotin-plus-immunotherapy-as-perioperative-regimen-for-bladder-cancer-302377461.html
SOURCE RemeGen Co., Ltd
FAQ
What was the pCR rate for REGMY's Disitamab Vedotin Phase II trial in bladder cancer?
How many patients were enrolled in REGMY's NCT05297552 bladder cancer study?
What was the event-free survival rate in REGMY's Phase II bladder cancer trial?
How safe was REGMY's Disitamab Vedotin combination therapy compared to traditional treatments?
When did REGMY receive breakthrough therapy designation for Disitamab Vedotin in China?
