Bladder Cancer

Durvalumab plus BCG induction/maintenance showed a tolerable safety profile in BCG-naive NMIBC, according to the phase 3b PATAPSCO study.

The sBLA for nogapendekin alfa inbakicept is supported by 36-month follow-up data from cohort B of the QUILT-3.032 trial.

Investigators urge caution in interpreting these results, acknowledging the inherent limitations of unanchored, population-adjusted indirect trial comparisons.

SunRISe-4: Genomic disease burden, TMB, and PD-L1 expression linked to pathologic overall response to neoadjuvant gemcitabine intravesical system plus cetrelimab in MIBC.

The pembrolizumab/BCG combo yielded clinical complete responses at 6 months in over 90% of very high-risk BCG-naive NMIBC patients.

"It's also encouraging that 96.8% of patients were free of progression to muscle-invasive or greater disease,” said Ashish M. Kamat, MD, MBBS.

The FDA approved atezolizumab for the adjuvant treatment of muscle invasive bladder cancer with ctDNA molecular residual disease after cystectomy.

UGN-103 (mitomycin) for intravesical solution sustained disease control through 6 months in the UTOPIA trial in recurrent intermediate-risk LG-NMIBC.

The phase 3 VOLGA trial showed perioperative durvalumab plus neoadjuvant enfortumab vedotin reduced the risk of death in muscle-invasive bladder cancer.

Mitomycin for intravesical solution demonstrated durable responses in 36-month follow-up data from the phase 3 ENVISION trial.

Interim data from the LEGEND pivotal cohort show detalimogene achieved complete responses in more than half of patients with BCG-unresponsive non-muscle invasive bladder cancer.

The FDA has granted a priority review to the supplemental biologics license application for enfortumab vedotin/pembrolizumab to all patients with MIBC regardless of cisplatin eligibility.

The FDA has granted fast track and rolling review status to Celltrion’s CT-P71, a Nectin-4 targeting ADC for treating advanced urothelial carcinoma.

CMS has issued a permanent billing and reimbursement J-code, J9183, for the gemcitabine intravesical system (Inlexzo) in NMIBC.

The FDA approved a label change for nadofaragene firadenovec-vncg (Adstiladrin) in non–muscle-invasive bladder cancer to improve preparation time.

Nadofaragene firadenovec-vncg (Adstiladrin) received an expanded NCCN recommendation for patients with BCG-unresponsive NMIBC.

The combination of nogapendekin alfa inbakicept-pmln (Anktiva) and Bacillus Calmette-Guérin was added to the NCCN clinical guidelines for bladder cancer, according to the manufacturer.

Sacituzumab govitecan plus pembrolizumab may enable bladder preservation in MIBC.

A supplemental Biologics License Application has been submitted for nogapendekin alfa inbakicept-pmln (Anktiva) plus BCG for patients with BCG-unresponsive non-muscle invasive bladder cancer with papillary tumors.

Induction ipilimumab/nivolumab plus chemoradiotherapy consolidation was associated with bladder preservation in muscle-invasive urothelial carcinoma.

AKY-1189 gains fast track designation in urothelial cancer.

IMvigor011 shows post-cystectomy ctDNA timing and levels predict relapse, while adjuvant atezolizumab clears ctDNA and extends survival in MIBC.

An integrated analysis of the RETAIN-1 and RETAIN-2 trials demonstrates that circulating tumor DNA is a powerful prognostic indicator for metastatic recurrence in muscle-invasive bladder cancer.

Phase 2 results showed efficacy and tolerability of disitamab vedotin in pretreated HER2+ and HER2-low urothelial cancer.

Neoadjuvant enfortumab vedotin plus pembrolizumab significantly improved event-free survival and overall survival compared with gemcitabine plus cisplatin.