Bladder Cancer

Among patients who discontinued enfortumab vedotin due to an ongoing response or toxicity, 57% were treatment-free and alive 1 year later.

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

The majority of patients experiencing recurrence of their MIBC within 6 months of study start had high concentrations of ctDNA at baseline.

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.

Experts break down the clinical trial data and regulatory developments that made 2025 a “remarkable year” in kidney and bladder cancer management.

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.

Results from the KEYNOTE-905 trial led to the approval of pembrolizumab/enfortumab vedotin in muscle invasive bladder cancer.

Most patients with BCG-unresponsive NMIBC treated with detalimogene voraplasmid did not experience TRAEs, and only 1.6% experienced dose interruptions.

The FDA agreed that data from the UTOPIA trial, with UGN-103 demonstrating a 77.8% 3-month CR rate in patients with LG-IR-NMIBC, support an NDA submission.

Among patients with locally advanced/metastatic urothelial cancer who received at least one 2.2 mg/kg dose of BL-B01D1, the confirmed ORR was 44.1%.

Immunotherapy-based combinations may elicit a synergistic effect that surpasses monotherapy outcomes among patients with muscle-invasive bladder cancer.

Enfortumab vedotin plus pembrolizumab before and after surgery improved EFS vs surgery alone in patients with MIBC in the phase 3 EV-303 trial.

Updated results from SunRISe-4 support further investigation of the gemcitabine intravesical system plus cetrelimab in MIBC.