What question did this study set out to answer?

This study aims to assess the efficacy and safety of an enfortumab vedotin and toripalimab combination compared to standard gemcitabine-cisplatin treatment in muscle-invasive bladder cancer.

March 4, 2026

Preliminary results from phase II enfortumab vedotin plus toripalimab compared to gemcitabine-cisplatin as neoadjuvant therapy for patients with muscle-invasive bladder cancer (MIBC).

Puntos clave

This study aims to assess the efficacy and safety of an enfortumab vedotin and toripalimab combination compared to standard gemcitabine-cisplatin treatment in muscle-invasive bladder cancer.
Open-label, multi-center, 2-arm clinical trial
Arm A: Enfortumab Vedotin plus Toripalimab, 4 cycles every 21 days
Arm B: Gemcitabine-Cisplatin 4 cycles every 21 days
Primary endpoints: pathological response and pathological complete response
Safety monitored through adverse events reporting.
In Arm A, 60% achieved pathological response and 40% achieved pathological complete response
In Arm B, 45.45% achieved pathological response, no pathological complete response reported
18 patients enrolled with adverse events primarily being fatigue and anemia

Resumen

782 Background: Cisplatin-based neoadjuvant chemotherapy is the standard of care in MIBC with improved overall survival (OS). Enfortumab Vedotin plus pembrolizumab prolongs OS in MIBC pts. This study will evaluate the efficacy and safety of toripalimab (an anti-PD-1 monoclonal antibody) combined with Enfortumab Vedotin (EVT) as neoadjuvant therapy in comparison with gemcitabine-cisplatin (GC) neoadjuvant regimen for patients with MIBC. Methods: This study is an open label, multi-center, 2-arm clinical trial. Arm A enrolls eligible pts with MIBC (cT2-T4a, N≤1, M0) who were candidates for RC. Enfortumab Vedotin (1.0mg/ m 2 d1,d8) plus Toripalimab (240mg, d1) every 21 days, up to 4 cycles. Arm B received GC chemotherapy (gemcitabine 1000mg/ d1,d8 plus cisplatin 35mg/m 2 d1,d2) every 21 days, up to 4 cycles. RC was performed within 4 weeks after the last dose treatment. The dual primary endpoint was PaR(≤ pT1,N0) and pCR (ypT0N0). Secondary endpoints were DFS at 2 years and safety. Results: Between Mar 2025 and Oct 2025. 18 pts (7 pts cT2, 6 pts cT3, 5 pts cT4) were enrolled. The median age was 69.5, and 61.1% (11/18) were male. 7 pts were enrolled in arm A, in which 5 pts completed all 4 cycles of EVT. All 11 pts in arm B completed 4 cycles of GC. 16 of the 18 pts underwent RC and two are still in EVT neoadjuvant cycles. Among EVT arm, PaR was 60% (3/5), and pCR was 40% (2/5). In GC arm, PaR was 45.45% (5/11), while no pts had achieved pCR. Survival data are not yet mature. The most common adverse events (AEs) of any grade were fatigue (17/18; 94.44%), anemia (16/18; 88.89%), and fever (10/18, 55.56%). 33.33% (6/18) pts had Grade ≥3 Severe AEs. One patient in GC arm had post-operative pneumonia. Two pts in GC arm had bowl obstruction. Two pts in GC arm and one patient in EVT arm had post-operative lymphocele. Conclusions: Neoadjuvant Enfortumab Vedotin plus Toripalimab demonstrated promising efficacy and safety in comparison with GC regimen in MIBC. This combination was well tolerated without any delays in RC and more data are required for mature conclusion.

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