Bladder Cancer

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.

More than 80% of patients in cohort B of the QUILT-3.032 study avoided cystectomy at 36 months after treatment with nogapendekin alfa plus BCG.

A clinically meaningful and statistically significant pathologic complete response rate advantage was seen with the enfortumab vedotin combination.

The intravesical MVR-T3911 treatment did not lead to any dose-limiting toxicities in patients with high-risk, BCG-unresponsive non-muscle invasive bladder cancer.

During treatment with TARA-002, there were no grade 3 or higher TRAEs, and TRAEs did not lead to any treatment discontinuations in patients with BCG-naïve NMIBC.

A 6-month CR rate of 62% was observed with detalimogene voraplasmid in treating patients with BCG-unresponsive non–muscle invasive bladder cancer.

HRQOL scores were similar among patients who received a radical cystectomy or bladder persevering therapy for non-muscle invasive bladder cancer.

Investigators are currently assessing the safety and preliminary activity of AVZO-103 among patients with advanced solid tumors in a phase 1/2 trial.