Poised to Reshape Treatment Landscape: The Phase 3 Clinical Trial of Disitamab Vedotin as a First-Line Therapy for HER2-Expressing Locally Advanced or Metastatic Urothelial Carcinoma Reached its Primary Endpoints of PFS and OS
RemeGen (REGMY) announced significant positive results from its Phase 3 clinical trial of disitamab vedotin (DV) in combination with PD-1 inhibitor toripalimab. The study, evaluating the treatment as a first-line therapy for HER2-expressing locally advanced or metastatic urothelial carcinoma (la/mUC), successfully met its primary endpoints of progression-free survival (PFS) and overall survival (OS).
The trial, involving 484 patients across 74 sites in China, demonstrated statistically significant improvements in both PFS and OS compared to standard chemotherapy, regardless of cisplatin eligibility or HER2 expression levels. The treatment showed a manageable safety profile with tolerable adverse reactions. RemeGen plans to file a Biologic License Application (BLA) with China's NMPA, with detailed data to be presented at upcoming international conferences.
RemeGen (REGMY) ha annunciato risultati positivi significativi dal suo studio clinico di fase 3 su disitamab vedotin (DV) in combinazione con l'inibitore PD-1 toripalimab. Lo studio, che valuta il trattamento come terapia di prima linea per il carcinoma uroteliale localmente avanzato o metastatico (la/mUC) con espressione HER2, ha raggiunto con successo gli endpoint primari di sopravvivenza libera da progressione (PFS) e sopravvivenza globale (OS).
La sperimentazione, che ha coinvolto 484 pazienti in 74 centri in Cina, ha mostrato miglioramenti statisticamente significativi sia nella PFS che nella OS rispetto alla chemioterapia standard, indipendentemente dall'idoneità al cisplatino o dai livelli di espressione HER2. Il trattamento ha evidenziato un profilo di sicurezza gestibile con reazioni avverse tollerabili. RemeGen prevede di presentare una domanda di autorizzazione biologica (BLA) presso la NMPA cinese, con dati dettagliati che saranno presentati a prossime conferenze internazionali.
RemeGen (REGMY) anunció resultados positivos significativos de su ensayo clínico de fase 3 con disitamab vedotin (DV) en combinación con el inhibidor de PD-1 toripalimab. El estudio, que evalúa el tratamiento como terapia de primera línea para el carcinoma urotelial localmente avanzado o metastásico (la/mUC) con expresión HER2, cumplió con éxito sus objetivos primarios de supervivencia libre de progresión (PFS) y supervivencia global (OS).
El ensayo, que involucró a 484 pacientes en 74 sitios en China, demostró mejoras estadísticamente significativas tanto en PFS como en OS en comparación con la quimioterapia estándar, independientemente de la elegibilidad para cisplatino o los niveles de expresión de HER2. El tratamiento mostró un perfil de seguridad manejable con reacciones adversas tolerables. RemeGen planea presentar una solicitud de licencia biológica (BLA) ante la NMPA de China, con datos detallados que se presentarán en próximas conferencias internacionales.
RemeGen (REGMY)은 PD-1 억제제 토리팔리맙과 병용한 디시타맙 베도틴(DV)의 3상 임상시험에서 중요한 긍정적 결과를 발표했습니다. 이 연구는 HER2 발현 국소 진행성 또는 전이성 요로상피암(la/mUC)에 대한 1차 치료제로서의 치료 효과를 평가했으며, 무진행 생존기간(PFS)과 전체 생존기간(OS)이라는 1차 평가변수를 성공적으로 충족했습니다.
중국 내 74개 기관에서 484명의 환자가 참여한 이번 임상시험은 시스플라틴 적격 여부나 HER2 발현 수준과 관계없이 표준 화학요법 대비 PFS와 OS 모두에서 통계적으로 유의미한 개선을 보였습니다. 치료는 관리 가능한 안전성 프로파일과 견딜 수 있는 부작용을 나타냈습니다. RemeGen은 중국 NMPA에 생물학적 허가 신청서(BLA)를 제출할 계획이며, 자세한 데이터는 곧 열릴 국제 학회에서 발표될 예정입니다.
RemeGen (REGMY) a annoncé des résultats positifs significatifs issus de son essai clinique de phase 3 portant sur le disitamab vedotin (DV) en association avec l'inhibiteur PD-1 toripalimab. L'étude, qui évalue ce traitement en première ligne pour le carcinome urothélial localement avancé ou métastatique (la/mUC) exprimant HER2, a atteint avec succès ses critères principaux de survie sans progression (PFS) et de survie globale (OS).
L'essai, impliquant 484 patients répartis dans 74 centres en Chine, a démontré des améliorations statistiquement significatives de la PFS et de l'OS par rapport à la chimiothérapie standard, indépendamment de l'éligibilité au cisplatine ou du niveau d'expression de HER2. Le traitement a présenté un profil de sécurité gérable avec des effets indésirables tolérables. RemeGen prévoit de déposer une demande d'autorisation biologique (BLA) auprès de la NMPA chinoise, avec des données détaillées qui seront présentées lors de prochaines conférences internationales.
RemeGen (REGMY) gab bedeutende positive Ergebnisse aus seiner Phase-3-Studie mit Disitamab Vedotin (DV) in Kombination mit dem PD-1-Inhibitor Toripalimab bekannt. Die Studie, die die Behandlung als Erstlinientherapie für HER2-exprimierenden lokal fortgeschrittenen oder metastasierten Urothelkarzinom (la/mUC) evaluiert, erreichte erfolgreich die primären Endpunkte des progressionsfreien Überlebens (PFS) und des Gesamtüberlebens (OS).
Die Studie, an der 484 Patienten an 74 Standorten in China teilnahmen, zeigte statistisch signifikante Verbesserungen sowohl beim PFS als auch beim OS im Vergleich zur Standardchemotherapie, unabhängig von der Cisplatin-Eignung oder dem HER2-Expressionsniveau. Die Behandlung wies ein gut handhabbares Sicherheitsprofil mit tolerierbaren Nebenwirkungen auf. RemeGen plant, einen Antrag auf Zulassung eines Biologikums (BLA) bei der chinesischen NMPA einzureichen, wobei detaillierte Daten auf bevorstehenden internationalen Konferenzen vorgestellt werden sollen.
- Phase 3 trial successfully met both primary endpoints (PFS and OS)
- Treatment showed efficacy regardless of cisplatin eligibility or HER2 expression level
- Demonstrated manageable safety profile and tolerable adverse reactions
- Plans to file BLA with China's NMPA for regulatory approval
- None.
RC48-C016 is a randomized, active-controlled, multi-center phase 3 clinical trial evaluating efficacy and safety of DV plus toripalimab versus gemcitabine in combination with cisplatin/carboplatin in systemic-treatment-naive patients with HER2-expressing (defined as IHC 1+, 2+ or 3+) la/mUC. The study was initiated in June 2022 and conducted in 74 sites across
The principal researcher of this study, Professor Guo Jun from Peking University Cancer Hospital, said: "Extremely exciting! We, once again, jointly witnessed a strong positive result of DV combined with toripalimab in the first-line treatment of advanced urothelial carcinoma. Regardless of whether the patients are suitable for cisplatin treatment and regardless of patients' HER2 expression status, DV combined with toripalimab significantly improved PFS and OS. This outstanding efficacy proves the success of the 'HER2-ADC + immunotherapy' combination treatment concept, and is also a major breakthrough in the global treatment of urothelial carcinoma. We look forward to the excellent performance of DV in subsequent studies which should provide better decision-making basis for clinicians, bring more benefits to patients, and reshape the global treatment landscape of urothelial carcinoma with the 'Chinese approach'."
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SOURCE RemeGen Co., Ltd
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