The Role of Enfortumab Vedotin Plus Pembrolizumab in Bladder Cancer

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.

Phase 2b SunRISe-1 data showed TAR-200 monotherapy achieved an 82.4% complete response rate in BCG-unresponsive, high-risk NMIBC with CIS. The 12-month CR rate was 45.9%, with durable responses and manageable safety. An FDA application is under review.

TAR-200 showed durable disease-free survival in high-risk, BCG-unresponsive papillary NMIBC in SunRISe-1, with high 6/9-month DFS rates and a low cystectomy rate.

Combining the antibody-drug conjugate disitamab vedotin with BCG elicited a high complete response rate in patients with HER2-expressing, high-risk NMIBC.