Bladder Cancer

Results from the KEYNOTE-905 trial led to the approval of pembrolizumab/enfortumab vedotin in muscle invasive bladder cancer.

Most patients with BCG-unresponsive NMIBC treated with detalimogene voraplasmid did not experience TRAEs, and only 1.6% experienced dose interruptions.

The FDA agreed that data from the UTOPIA trial, with UGN-103 demonstrating a 77.8% 3-month CR rate in patients with LG-IR-NMIBC, support an NDA submission.

Among patients with locally advanced/metastatic urothelial cancer who received at least one 2.2 mg/kg dose of BL-B01D1, the confirmed ORR was 44.1%.

Enfortumab vedotin plus pembrolizumab before and after surgery improved EFS vs surgery alone in patients with MIBC in the phase 3 EV-303 trial.

Updated results from SunRISe-4 support further investigation of the gemcitabine intravesical system plus cetrelimab in MIBC.

Data from POTOMAC support durvalumab plus BCG and induction and maintenance therapy as a new treatment option in BCG-naive, high-risk NMIBC.

New findings reveal that adding durvalumab to neoadjuvant chemotherapy does not enhance HRQOL in muscle-invasive bladder cancer patients.

Using multiparametric MRI for initial staging, then cystoscopic biopsy, improves bladder cancer-specific survival compared with transurethral resection of bladder tumor staging.

Updated results from CheckMate 274 support adjuvant nivolumab as a standard of care for patients with high-risk muscle-invasive urothelial carcinoma.

The safety profile of the atezolizumab with Bacillus Calmette-Guérin in NMIBC was consistent with that of each individual agent.

Data support the intravesical mitomycin solution’s role as an innovative option for those with recurrent, low-grade, intermediate-risk NMIBC.

No toxicity-related discontinuations were seen with adjuvant radiotherapy among patients with muscle-invasive bladder cancer.

Gary Steinberg, MD, compared the AE profile of the gemcitabine intravesical system for BCG-unresponsive NMIBC with other intravesical therapies.

Gary Steinberg, MD, highlights the FDA approval of the gemcitabine intravesical system and what this means for patients with BCG-unresponsive NMIBC.

In patients who refuse or are ineligible for radical cystectomy, the gemcitabine intravesical system may be given after unsuccessful BCG treatment.

Patients with muscle-invasive bladder cancer with a positive Signatera test displayed a significant improvement in disease-free and overall survival.

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.