Bladder Cancer

Data from cohort 4 of the phase 2 SunRISe-1 trial demonstrate durable DFS with TAR-200 in BCG-unresponsive, papillary-only, high-risk non–muscle-invasive bladder cancer.

Nogapendekin alfa inbakicept plus BCG led to a CR rate of 71%, with 60% of responders maintaining their response for at least 12 months, in patients with bladder carcinoma in situ.

Complete response rates were observed consistently across patient subgroups in those with high-risk BCG-unresponsive non-muscle invasive bladder cancer.

18F-FDG PET/CT staging of lymph node metastases in patients with bladder cancer undergoing radical cystectomy did not correlate with worse survival outcomes.

Findings may establish a framework for assisting patient counselling and optimizing therapy selection for those undergoing radical cystectomy.

Data from a Japanese trial add to the body of evidence supporting the favorable efficacy and safety of nadofaragene firadenovec for this NMIBC population.

In quarter 1 of 2025, nogapendekin alfa inbakicept received regenerative medicine advanced therapy designation for lymphopenia.

Combining durvalumab with chemotherapy produced a good safety profile without increasing surgical risk in the phase 2 iNDUCT-GETUG V08 trial.

Results from the phase 3 NIAGARA trial led to the approval of adjuvant durvalumab/chemotherapy for patients with muscle-invasive bladder cancer after radical cystectomy.

No grade 3 or higher treatment-related adverse effects or deaths were reported among those with non-muscle invasive bladder cancer in the BOND-003 trial.

In patients with low-grade intermediate-risk non-muscle invasive bladder cancer who achieved a CR at 3 months with UGN-102, the 18-month DOR was 80.6%.

Retrospective analyses found that antihistamines added to atezolizumab yielded a 46% OS rate, a 48% CSS rate, and a 23% PFS rate in patients with metastatic urothelial carcinoma.

Outcomes observed in the phase 3 EV-302 trial are “transformative” for most patients with advanced or metastatic urothelial carcinoma.

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.