Bladder Cancer

Results from the SunRISe-1 trial showed that TAR-200 monotherapy achieved a complete response rate of 82.4% in patients with BCG-unresponsive NMIBC.

Patients with cisplatin-ineligible bladder cancer who received enfortumab vedotin plus pembrolizumab and surgery had prolonged survival vs those who received surgery alone.

Adverse reactions in the phase 3 ENVISION trial were largely mild to moderate in severity, and serious reactions occurred in 12% of those with NMIBC.

Phase 2b SunRISe-1 trial findings supported the FDA to grant priority review to TAR-200 in BCG-unresponsive high-risk NMIBC with carcinoma in situ.

The phase 3 UTOPIA trial has enrolled a total of 99 patients with low-grade intermediate-risk NMIBC to receive UGN-103.

Use of the novel artificial intelligence–based test may provide a painless, low-cost alternative in bladder cancer screening.

Detalimogene voraplasmid demonstrated a 71% anytime CR rate in this non–muscle-invasive bladder cancer population in the phase 1/2 LEGEND trial.

Data from the phase 3 ENVISION trial support the FDA approval of the mitomycin solution for patients with recurrent, low-grade, intermediate-risk NMIBC.

Data from the ENVISION trial may support UGN-102 as a well-tolerated, efficacious treatment in non–muscle-invasive bladder cancer.

A combination of BCG and mitomycin offers a comparable treatment option to BCG monotherapy for NMIBC, potentially lessening the impact of global BCG shortages.

Sasanlimab plus BCG significantly improved event-free survival in BCG-naïve, high-risk NMIBC patients, with notable benefit in carcinoma in situ and T1 tumors.

Real-world data may support chemotherapy plus immune checkpoint blockade as a promising frontline neoadjuvant therapy for muscle-invasive 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.