Bladder Cancer

The approved combination of enfortumab vedotin and pembrolizumab provides an alternative to chemotherapy for patients in China.

The FDA set a Prescription Drug User Fee act date in the second quarter of 2025 for durvalumab plus chemotherapy in muscle-invasive bladder cancer.

“How do we personalize and improve patient selection for frontline treatment now that patients are living, on average, more than 2 years with this aggressive cancer?” said David H. Aggen, MD, PhD

Pembrolizumab with platinum-based chemotherapy yielded encouraging progression-free and overall survival outcomes in this patient population.

Disease-free survival and overall survival were lower with extended lymphadenectomy compared with standard lymphadenectomy.

Data from TROPiCS-04 did not meet the primary end point of overall survival among those with locally advanced or metastatic urothelial cancer.

The decision is backed by robust efficacy data from the phase 3 ENVISION trial, evaluating UGN-102 in patients with non-muscle invasive bladder cancer.

TAR-200 plus cetrelimab did not yield significant results vs chemoradiation in muscle-invasive bladder cancer.

Phase 3 EV-302 results supported the approval, showing a statically significant survival benefit compared with chemotherapy in urothelial carcinoma.

Data from the SunRISe-4 trial demonstrate the benefit of adding TAR-200 to checkpoint inhibition among patients with muscle-invasive bladder cancer.

Thomas Powles, MBBS, MRCP, MD, presented results from the NIAGRA trial assessing perioperative durvalumab in patients with cisplatin-eligible MIBC.

Durvalumab improved efficacy in patients with muscle-invasive bladder cancer.

UGN-102 also demonstrated a 79.6% complete response rate at 3 months in the phase 3 ENVISION trial.

Patient-reported outcomes from the EV-302 trial found consistent efficacy and safety outcomes for patients with urothelial carcinoma.

Limited efficacy was observed when sacituzumab govitecan was given after enfortumab vedodin in metastatic urothelial carcinoma.

Adjuvant sacituzumab govitecan demonstrated a complete response, but its future in bladder cancer is uncertain after a recent protocol amendment.

Neoadjuvant avelumab plus cisplatin yielded high event-free survival in muscle-invasive urothelial carcinoma.

The CheckMate -901 trial led to the approval of the nivolumab combination for unresectable or metastatic urothelial carcinoma in the European Union.

Nivolumab plus ipilimumab has shown a response benefit when given at an increased dose for those with metastatic urothelial carcinoma.

Kirollos S. Hanna, PharmD, BCPS, BCOP, FACCC, gives his perspective on the approval of enfortumab vedotin plus pembrolizumab for patients with urothelial carcinoma.

Phase 2 data support the potential of replacing cisplatin with nab-paclitaxel as a backbone therapy for those with muscle-invasive bladder cancer.

Findings from the CheckMate-901 study support the use of frontline nivolumab plus gemcitabine/cisplatin in advanced urothelial carcinoma.

All patients with a response to TAR-200 did not have progression to muscle-invasive bladder cancer or metastatic disease in the SunRISe-1 trial.

Treatment with cretostimogene grenadenorepvec appears tolerable among patients with high-risk BCG–unresponsive NMIBC in the phase 3 BOND-003 trial.

Findings from the CheckMate-901 trial support the CHMP’s positive opinion of nivolumab plus chemotherapy in metastatic urothelial carcinoma.