Bladder Cancer

ODAC has voted against the use of UGN-102 intravesical solution for patients with advanced bladder cancer.

Treatment with disitamab vedotin and toripalimab improves survival regardless of cisplatin eligibility or HER2 expression level in the phase 3 RC48-C016 trial.

Data from the POTOMAC trial evaluating durvalumab in NMIBC will be presented at a future medical meeting and shared with global regulatory authorities.

A new type of robotic posterior surgery has been shown to be a treatment option for patients with devastated bladder outlets.

The FDA refuses to file the sBLA for nogapendekin alfa inbakicept plus BCG in BCG-unresponsive NMIBC with papillary disease without carcinoma in situ.

Results from the phase 3 ENVISION trial suggest UGN-102 could be a non-surgical alternative to TURBT for recurrent low-grade intermediate-risk NMIBC.

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.