Published in Annals of Oncology: Disitamab Vedotin Combined with PD-1 Inhibitor is a Promising Treatment for Locally Advanced or Metastatic Urothelial Carcinoma
RemeGen's phase 1b/2 clinical trial results for Disitamab Vedotin (DV) combined with Toripalimab in treating locally advanced or metastatic urothelial carcinoma (la/mUC) were published in Annals of Oncology. The nearly three-year follow-up data showed impressive results with a 73.2% objective response rate (ORR) and 33.1 months median overall survival (OS).
The study enrolled 41 patients between August 2020 and December 2021. Key findings include: 9.8% complete response rate, 63.4% partial response rate, 90.2% disease control rate (DCR), 9.3 months median progression-free survival (PFS), and 8.6 months median duration of response (DOR). The 36-month OS rate was 49.2%.
Notably, patients with HER2 expression (IHC 1+/2+/3+) showed better outcomes with 76.3% ORR compared to 33.3% in HER2 IHC 0 patients. The therapy demonstrated efficacy across various subgroups, including chemotherapy-naïve patients (76.0% ORR) and those who progressed on platinum-based chemotherapy (68.8% ORR).
I risultati della fase 1b/2 dello studio clinico di RemeGen per Disitamab Vedotin (DV) combinato con Toripalimab nel trattamento del carcinoma uroteliale localmente avanzato o metastatico (la/mUC) sono stati pubblicati negli Annals of Oncology. I dati di follow-up di quasi tre anni hanno mostrato risultati impressionanti con un tasso di risposta oggettiva (ORR) del 73,2% e una sopravvivenza globale mediana (OS) di 33,1 mesi.
Lo studio ha arruolato 41 pazienti tra agosto 2020 e dicembre 2021. I principali risultati includono: 9,8% di tasso di risposta completa, 63,4% di tasso di risposta parziale, 90,2% di tasso di controllo della malattia (DCR), 9,3 mesi di sopravvivenza libera da progressione mediana (PFS) e 8,6 mesi di durata mediana della risposta (DOR). Il tasso di OS a 36 mesi era del 49,2%.
È importante notare che i pazienti con espressione di HER2 (IHC 1+/2+/3+) hanno mostrato risultati migliori con un ORR del 76,3% rispetto al 33,3% negli pazienti IHC 0 per HER2. La terapia ha dimostrato efficacia attraverso vari sottogruppi, inclusi i pazienti naïve alla chemioterapia (ORR del 76,0%) e quelli che hanno progredito su chemioterapia a base di platino (ORR del 68,8%).
Los resultados del ensayo clínico de fase 1b/2 de RemeGen para Disitamab Vedotin (DV) combinado con Toripalimab en el tratamiento del carcinoma urotelial localmente avanzado o metastásico (la/mUC) fueron publicados en los Annals of Oncology. Los datos de seguimiento de casi tres años mostraron resultados impresionantes con una tasa de respuesta objetiva (ORR) del 73,2% y una supervivencia global mediana (OS) de 33,1 meses.
El estudio inscribió a 41 pacientes entre agosto de 2020 y diciembre de 2021. Los hallazgos clave incluyen: una tasa de respuesta completa del 9,8%, una tasa de respuesta parcial del 63,4%, un tasa de control de la enfermedad (DCR) del 90,2%, una supervivencia libre de progresión mediana (PFS) de 9,3 meses, y una duración mediana de la respuesta (DOR) de 8,6 meses. La tasa de OS a los 36 meses fue del 49,2%.
Vale la pena destacar que los pacientes con expresión de HER2 (IHC 1+/2+/3+) mostraron mejores resultados con un ORR del 76,3% en comparación con el 33,3% en pacientes con HER2 IHC 0. La terapia demostró eficacia en varios subgrupos, incluidos los pacientes quimioterapia-naïve (ORR del 76,0%) y aquellos que progresaron con quimioterapia basada en platino (ORR del 68,8%).
RemeGen의 DISITAMAB VEDOTIN(DV)와 토리팔리맙의 조합으로 진행된 1b/2상 임상 시험 결과가 Annals of Oncology에 발표되었습니다. 거의 3년 간의 추적 연구에서 73.2%의 객관적 반응률(ORR)과 33.1개월의 중앙 전체 생존 기간(OS)을 보여주는 인상적인 결과를 나타냈습니다.
이 연구는 2020년 8월부터 2021년 12월까지 41명의 환자를 등록했습니다. 주요 발견 사항으로는: 9.8%의 완전 반응률, 63.4%의 부분 반응률, 90.2%의 질병 조절률(DCR), 9.3개월의 중앙 무 progressing 생존 기간(PFS), 그리고 8.6개월의 중앙 반응 지속 기간(DOR)입니다. 36개월 OS 비율은 49.2%였습니다.
특히 HER2 발현(IHC 1+/2+/3+) 환자들은 HER2 IHC 0 환자에 비해 76.3%의 ORR을 보여주며 더 나은 결과를 보였습니다. 이 치료는 화학요법 미수술 환자(76.0% ORR)와 백금 기반 화학요법에 실패한 환자(68.8% ORR)를 포함한 다양한 하위 그룹에서도 효능을 입증했습니다.
Les résultats de l'essai clinique de phase 1b/2 de RemeGen pour Disitamab Vedotin (DV) combiné avec Toripalimab dans le traitement du carcinome urothélial localement avancé ou métastatique (la/mUC) ont été publiés dans les Annals of Oncology. Les données de suivi de près de trois ans ont montré des résultats impressionnants avec un taux de réponse objective (ORR) de 73,2 % et une survie globale médiane (OS) de 33,1 mois.
L'étude a inclus 41 patients entre août 2020 et décembre 2021. Les principales conclusions incluent : 9,8 % de taux de réponse complète, 63,4 % de taux de réponse partielle, 90,2 % de taux de contrôle de la maladie (DCR), 9,3 mois de survie sans progression médiane (PFS), et 8,6 mois de durée de réponse médiane (DOR). Le taux de OS à 36 mois était de 49,2 %.
Il est à noter que les patients avec expression de HER2 (IHC 1+/2+/3+) ont montré de meilleurs résultats avec un ORR de 76,3 % par rapport à 33,3 % chez les patients HER2 IHC 0. La thérapie a démontré son efficacité dans divers sous-groupes, y compris les patients naïfs de chimiothérapie (ORR de 76,0 %) et ceux qui ont progressé sous chimiothérapie à base de platine (ORR de 68,8 %).
Die Ergebnisse der Phase 1b/2 klinischen Studie von RemeGen zu Disitamab Vedotin (DV) in Kombination mit Toripalimab zur Behandlung von lokal fortgeschrittenem oder metastasiertem urotelialen Karzinom (la/mUC) wurden in den Annals of Oncology veröffentlicht. Die Nachfolgedaten von fast drei Jahren zeigten beeindruckende Ergebnisse mit einer objektiven Ansprechrate (ORR) von 73,2% und einer medianen Gesamtüberlebenszeit (OS) von 33,1 Monaten.
In der Studie wurden 41 Patienten zwischen August 2020 und Dezember 2021 eingeschlossen. Zu den wichtigsten Ergebnissen gehören: 9,8% vollständige Ansprechrate, 63,4% partielle Ansprechrate, 90,2% Krankheitskontrollrate (DCR), 9,3 Monate mediane progressionsfreie Überlebenszeit (PFS) und 8,6 Monate mediane Ansprechdauer (DOR). Die OS-Rate nach 36 Monaten betrug 49,2%.
Bemerkenswerterweise zeigten Patienten mit HER2-Expression (IHC 1+/2+/3+) bessere Ergebnisse mit einer ORR von 76,3% im Vergleich zu 33,3% bei HER2 IHC 0-Patienten. Die Therapie zeigte Wirksamkeit in verschiedenen Untergruppen, einschließlich chemotherapie-naiven Patienten (ORR 76,0%) und solchen, die auf platinbasierte Chemotherapie nicht angesprochen hatten (ORR 68,8%).
- High objective response rate of 73.2% in clinical trial
- Strong median overall survival of 33.1 months
- 90.2% disease control rate achieved
- Effective across multiple patient subgroups, including chemotherapy-naïve (76.0% ORR) and post-platinum therapy (68.8% ORR)
- Better outcomes in HER2-expressing patients (76.3% ORR vs 33.3% in non-expressing)
- None.
It is the first time that long-term follow-up data has been released for a HER2-targeted antibody-drug conjugate (ADC) and PD-1 inhibitor combination therapy in treating la/mUC, marking it a significant milestone. The nearly-three-year follow-up data revealed an objective response rate (ORR) of
New Treatment Options for Patients with La/mUC
UC is the sixth most common cancer worldwide. GLOBOCAN 2022 estimated the year 2021 saw 614,298 new cases and 220,596 deaths of UC. In recent years, the prognosis for patients with la/mUC has significantly improved with new drugs and combination therapies approved, among which ADCs demonstrated outstanding potential.
As a HER2-targeted ADC, DV has been approved in
Multiple clinical studies on la/mUCin recent years have confirmed the synergistic antitumor effects of ADC combined with immunotherapy. NCT04264936 offered stronger evidence as its long-term follow-up results published in the Annals of Oncology demonstrated the high response rate, significant survival benefits, and manageable safety profile of the DV and Toripalimab combination therapy.
DV Combined with Toripalimab: High Response Rate and Prolonged Survival
NCT04264936 is an open-label, multicenter, investigator-initiated phase 1b/2 clinical trial investigating the safety and efficacy of DV in combination with Toripalimab for the treatment of patients with HER2-expressing la/mUC. The dose-escalation study (phase 1b) assessed two dose levels of DV (1.5 and 2.0 mg/kg) combined with Toripalimab (3.0 mg/kg) to determine the recommended phase 2 dose which was then evaluated in the dose-expansion stage (phase 2).
From August 2020 to December 2021, 41 patients were enrolled with a median age of 66 years.
As of March 1, 2024, among all participants, the ORR was
Subgroup analysis revealed ORR benefits across all subgroups regardless of the number of prior lines of systemic treatments, HER2 expression (IHC 1+/2+/3+), and PD-L1 expression status. The ORRs for chemotherapy-naïve patients and those who progressed on platinum-based chemotherapy were
In summary, the DV and Toripalimab combination therapy has preliminarily demonstrated promising efficacy and manageable safety profile among patients with la/mUC, wherein those with HER2 expression (IHC 1+/2+/3+) achieved high response rates and long-term survival benefits. These findings support the further exploration and validation of the benefits of DV combined with PD-1 inhibitors in treating la/mUC.
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SOURCE RemeGen Co., Ltd
FAQ
What are the key efficacy results of RemeGen's DV and Toripalimab combination therapy for la/mUC?
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What is the 36-month overall survival rate for patients treated with DV and Toripalimab?
