Bladder Cancer

Updated EV-302 data show EV plus pembrolizumab maintained superior OS and doubled CR rates over chemotherapy in first-line urothelial carcinoma.

Data from the phase 3 POTOMAC trial supported the FDA approval of durvalumab plus BCG in this non-muscle invasive bladder cancer population.

Event-free survival, overall survival, and pathologic complete rate data from the phase 3 KEYNOTE-905 trial support the agency’s decision.

The agency set a Prescription Drug User Fee Act target action date for January 6, 2027, for patients with NMIBC with papillary tumors without CIS.

The investigational BCG-containing regimen conferred a weighted anytime CR rate of 69.7% vs 53.4% with nadofaragene firadenovec in this NMIBC group.

Nurses at Johns Hopkins Nursing utilized a checklist for the chemotherapy gel administration via nephrostomy tube in patients with urothelial cancer.

Data from the phase 3 IMvigor011 trial support the approval of adjuvant atezolizumab in this ctDNA MRD-positive MIBC population.

Results from the phase 3 VOLGA trial demonstrate that perioperative durvalumab plus neoadjuvant enfortumab vedotin significantly improved EFS and OS in MIBC.

The 36-month DOR rate was 64.5% among patients who achieved a 3-month CR with mitomycin for low-grade, intermediate-risk non–muscle-invasive bladder cancer.

Hiba Siddiqui, BSc, of Dana-Farber discussed how targeting the CD44-SPP1 axis may overcome therapy resistance in muscle-invasive bladder cancer.

Findings from the phase 3 EV-304 trial support the supplemental biologics license application for enfortumab vedotin/pembrolizumab in patients with MIBC.

CT-P71 is being assessed in patients with locally advanced or metastatic urothelial carcinoma.

Alexander Z. Wei, MD, highlighted key clinical trials presented at ASCO GU and initiated at Columbia University to “move the needle” in bladder cancer.

Phase 2 Cyto-KIK findings showed that a subset of patients with high-risk kidney cancer exhibited responses and underwent monitoring post-cabozantinib.

Phase 3 ENVISION trial data revealed a 72.2% probability of remaining event-free among responders to UGN-102 with non-muscle invasive bladder cancer.

The FDA previously approved the gene therapy as a treatment for high-risk BCG-unresponsive NMIBC with CIS plus or minus papillary tumors in December 2022.

The resubmission occurred after discussions with the FDA in January 2026, where the agency requested additional data to support its review.

No grade 3 or greater treatment-related AEs or discontinuations were observed among patients with bladder cancer treated with the investigational agent.

Data from RETAIN-1 and RETAIN-2 show the chemoradiotherapy or BCG may remain viable options in those with ctDNA negativity but evidence of local disease.

Phase 3 data support perioperative enfortumab vedotin plus pembrolizumab as a novel treatment option in MIBC regardless of eligibility for cisplatin.

Of 78 patients with NMIBC in the phase 2 clinical trial, 64.4% experienced a complete response with TLD-1433.

A correlation between miR-93-5p and basal-like tumor features was observed among urinary samples of patients with bladder cancer.

Zelenectide pevedotin demonstrated manageable safety among patients with advanced solid tumors in the phase 1/2 Duravelo-1 trial.

The requested information does not pertain to the design or initiation of any new trials, and the developers plan to provide it in the next 30 days.

Data from the QUILT-3.032 trial supported the Saudi approval of nogapendekin alfa plus BCG in adults with BCG-unresponsive NMIBC with carcinoma in situ.