Antibody-drug conjugates for bladder sparing: lessons from SURE-02 trial
Mené sur 49 patients atteints d'un cancer de la vessie avec envahissement musculaire (âge médian : 66 ans), cet essai de phase II évalue l'efficacité, du point de vue du taux de réponse complète, et la toxicité d'un traitement néoadjuvant combinant sacituzumab govitécan et pembrolizumab, suivi d'un traitement adjuvant par pembrolizumab
Historically, perioperative cisplatin based neoadjuvant therapy has remained the gold standard for muscle-invasive bladder cancer. In the past 5 years, several practice changing trials have enabled the incorporation of immune checkpoint inhibitors in the perioperative setting for muscle-invasive bladder cancer. The phase 3 NIAGARA study led to the approval of durvalumab in combination with gemcitabine or cisplatin followed by adjuvant immune checkpoint inhibitor monotherapy.1 The CheckMate-274 and AMBASSADOR trials showed improved outcomes in patients treated with adjuvant immune checkpoint inhibitors.2,3 In 2025, antibody drug conjugates redefined the therapeutic strategy for muscle-invasive bladder cancer. The landmark EV-303/KEYNOTE 905 trial established a new framework combining neoadjuvant and adjuvant use of antibody–drug conjugates plus immune checkpoint inhibitor therapies.4 This trial showed a significant improvement in event-free survival, overall survival, and unprecedented pathological complete response rates with Nectin-4 directed antibody drug conjugates, enfortumab vedotin, in combination with pembrolizumab in patients who were ineligible for or declined cisplatin. Top-line results from the EV-304/KEYNOTE-B-15 study, evaluating enfortumab vedotin plus pembrolizumab perioperatively in cisplatin-eligible patients will be presented at an upcoming international meeting; a recent press release suggests the trial has met both the primary and secondary endpoints (event-free survival, pathological complete response, and overall survival).5 These studies used the unique approach of delivering antibody–drug conjugates and immune checkpoint inhibitor combinations in both the neoadjuvant and adjuvant settings. Against this backdrop, Andrea Necchi and colleagues present the results of the SURE-02 trial, a phase 2 study evaluating TROP-2 directed antibody–drug conjugates, sacituzumab govitecan, in combination with pembrolizumab.
The Lancet Oncology , commentaire, 2026