Bladder Cancer

Data from the ENVISION and ATLAS trials demonstrated clinically meaningful responses with UGN-102 in the treatment of low-grade, intermediate-risk NMIBC.

Data from the EV-302 trial support enfortumab vedotin plus pembrolizumab as a new standard of care in frontline urothelial cancer.

The safety profile of dato-DXd in the phase 1 TROPION-PanTumor01 trial is comparable with prior reports of the agent.

Avelumab maintenance demonstrated improved survival outcomes in advanced urothelial carcinoma, including patients with diabetes, in the JAVELIN Bladder 100 study.

Patients with neuropathy experienced a longer PFS with enfortumab vedotin vs those without neuropathy, skin rash, or hyperglycemia.

Data from CheckMate-274 support adjuvant nivolumab as a standard of care in high-risk muscle-invasive urothelial carcinoma.

Investigators assessed the long-term outcomes of neoadjuvant chemotherapy plus chemoradiation in those with non-metastatic muscle-invasive bladder cancer.

UGN-102 elicited complete responses in 79.6% of patients with non–muscle-invasive bladder cancer at 3 months in the ENVISION trial.

Data from the phase 2b SunRISe-1 study support the NDA for TAR-200 in patients with BCG-unresponsive high-risk non–muscle-invasive bladder cancer with CIS.

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.