Safety Profile Considerations for Enfortumab Vedotin Plus Pembrolizumab

The FDA ODAC decided that the overall benefit-risk of the investigational therapy UGN-102 is not favorable in patients with recurrent low-grade, intermediate-risk NMIBC.

Disitamab vedotin plus toripalimab showed significant survival benefits vs chemo in first-line HER2+ advanced urothelial carcinoma, with a manageable safety profile.

Durvalumab plus full BCG significantly improved disease-free survival in high-risk early bladder cancer vs BCG alone in the POTOMAC trial.

Bladder cancer patients undergoing radical cystectomy after pelvic radiotherapy showed increased risks of rectal injury, readmission, sepsis, and surgical-site infections compared with primary surgery.

A phase 3 trial showed neoadjuvant mitomycin C before TURBT in NMIBC patients was safe. While 12-month recurrence-free survival was similar to standard care, an 18-month trend suggested a possible delayed benefit.

ENVISION trial 18-month data show UGN-102 yielded a high initial complete response (79.6%) in recurrent low-grade intermediate-risk NMIBC, with 80.6% maintaining response. The gel formulation with mitomycin offers a nonsurgical chemoablation with favorable tolerability.