KEYNOTE-905 study of neoadjuvant and adjuvant (neoadj-adj) Enfortumab Vedotin (EV) plus pembrolizumab (pembro) in participants with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible: Assessment of surgical outcomes

초록

Introduction & Objectives: Adding neoadj-adj EV + pembro to radical cystectomy with pelvic lymph node dissection (RC + PLND) significantly improved EFS, OS, and pCR rate vs RC + PLND alone in pts with MIBC who are cisplatin-ineligible (KEYNOTE-905/EV-303; NCT03924895). RC + PLND is associated with notable complications and mortality, especially in frail pts with ≥1 comorbidity. We report surgical outcomes in KEYNOTE-905. Results: 149/170 pts (87.6%) in the EV + pembro arm and 156/174 (89.7%) in the control underwent RC + PLND; surgery delay occurred in 18/149 (12.1%) in the EV + pembro arm (n=6 due to AE) and in 25/156 pts (16.0%) in the control (n=1 due to AE). Most common reasons for not undergoing RC + PLND were pt withdrawal (n=10/21 in EV + pembro arm, n=13/18 in control), and AEs (n=7/21 and n=3/18, respectively). 3 pts in EV + pembro arm proceeded directly to surgery and are included in control arm for safety analysis. 67.8% in the EV + pembro arm and 64.8% in the control had a TEAE during surgery phase; table shows most common grade ≥3 TEAEs. Most common (≥5 pts in any arm) serious TEAEs during surgery phase were urinary tract infection (UTI; 4.8% in EV + pembro arm; 9.4% in control) and urosepsis (2.1% and 3.8%, respectively). Among pts with surgery, 10.1% in the EV + pembro arm and 50.0% in the control had any subsequent non-study therapy; among pts who did not undergo surgery, 42.9% and 38.9% had subsequent therapy. Surgical TEAEs of medical interest and TEAEs by treatment phase will also be presented.