Bladder Cancer

Pembrolizumab appears to achieve antitumor activity in terms of disease-free survival in patients with Bacillus calmette-guerin–unresponsive, papillary high–risk, non-muscle invasive bladder cancer.

Extended follow-up findings further support the use of nivolumab as a standard of care in high-risk muscle-invasive urothelial carcinoma following radical resection.

Data from the phase 2 TROPHY-U-01 trial support further evaluation of sacituzumab govitecan in patients with metastatic urothelial cancer following immune checkpoint inhibitor therapy, according to the lead investigator.

Findings from the phase 2 UNITE study indicate that certain biomarkers may help inform clinical decision making and sequencing in patients with advanced urothelial carcinoma.

Almost half of patients with muscle-invasive bladder cancer in a phase 2 trial had clinical complete responses following transurethral resection of bladder tumors plus nivolumab and chemotherapy.

Investigators identify an association between circulating tumor DNA in the blood plasma detected via the RaDaR assay and response to treatment with neoadjuvant immunotherapy for muscle-invasive bladder cancer.

Patients with previously untreated, locally advanced or metastatic urothelial carcinoma responded to treatment with trilaciclib and avelumab.

BT8009 monotherapy, which received fast track designation from the FDA, may be beneficial for adult patients with locally advanced or metastatic urothelial cancer.

The FDA has set the Prescription Drug User Fee Act date for April 21, 2023 for each supplemental biologics license application of enfortumab vedotin-ejfv and pembrolizumab in urothelial carcinoma.

Patients with high-risk Bacillus Calmette Guérin–unresponsive non-muscle invasive bladder cancer can now receive treatment with nadofaragene firadenovec-vncg—the first gene therapy—following its approval by the FDA.

Long-term follow-up showed that the use of pembrolizumab monotherapy maintained durable complete responses, while rates of upstaging at the time of radical cystectomy were consistent with previous findings in the KEYNOTE-057 trial in patients with a bladder cancer subset.

Findings from an interim analysis of data show that the addition of blue light cystoscopy to conventional white light significantly improved clinical outcomes in a group of patients with non–muscle-invasive bladder cancer.

Patients with cisplatin-ineligible muscle-invasive bladder cancer experienced a better rate of downstaging and improved survival benefit with neoadjuvant pembrolizumab prior to radical cystectomy vs immediate radical cystectomy.

Atezolizumab is no longer available to treat patients with advanced or metastatic bladder cancer following the manufacturer’s decision to withdraw its U.S. indication after consulting with the FDA.

Rogaratinib showed similar efficacy and manageable safety compared with chemotherapy in the management of FGFR1/3 mRNA–positive locally advanced or metastatic urothelial carcinoma.

Findings from Cohort K of the EV-103 trial demonstrated a 64.5% overall response rate with enfortumab vedotin plus pembrolizumab in metastatic urothelial cancer.

At ESMO 2022, peripheral blood samples taken from patients with advanced or metastatic urothelial carcinoma treated on the phase 3 JAVELIN Bladder 100 trial showed there may be a potential to predict disease response to avelumab.

Shilpa Gupta, MD, and Vinit Makkar, MD, discuss the treatment patterns and disease management of locally advanced/metastatic urothelial carcinoma, with a focus on data from the US physician-based PARADIGM study.

Patients with Bacillus Calmette-Guérin–unresponsive non-muscle invasive bladder carcinoma in situ appear to benefit from treatment with N-803, leading to the FDA accepting its biologics license application.

Results from cohort K of the phase 1b/2 KEYNOTE-869 trial showed improved responses for patients with advanced or metastatic urothelial carcinoma when treated with enfortumab vedotin-efjv plus pembrolizumab.

Belzupacap sarotalocan received fast track designation from the FDA for and will be assessed in a phase 1 clinical trial of patients with non–muscle invasive bladder cancer.

Expert panelists focus on the treatment of metastatic urothelial cancer and discuss strategies and challenges for maintenance therapy.

A manageable safety profile and good clinical activity were observed with toripalimab in Chinese patients with urothelial carcinoma.

An exploratory analysis of the JAVELIN Bladder 100 study indicated long-term overall survival benefit for patients with advanced urothelial carcinoma who received avelumab maintenace, without regard for treatment given in the second-line setting.

Results from the phase 2 ATLANTIS trial did not show a benefit of cabozantinib in patients with advanced urothelial carcinoma compared with the placebo, but the treatment appeared to be tolerable.

Results of the COSMIC-021 trial presented at ASCO 2022 show promise of cabozantinib plus atezolizumab for urothelial carcinoma.

Daniel Petrylak, MD, and Donald Barry Boyd, MD, MS, review a publication presenting use of avelumab maintenance in patients with locally advanced or metastatic urothelial carcinoma in real-world practice and discuss their own experiences with the regimen.

The JAVELIN Bladder 100 trial demonstrated that avelumab plus best supportive care prolonged overall survival vs best supportive care alone for patients with advanced urothelial carcinoma.

Patients with upper tract urothelial carcinoma may benefit from treatment with oral FGFR1-3 inhibitor infigratinib.

Neoadjuvant atezolizumab as a treatment for muscle-invasive urothelial cancer of the bladder yielded a high disease-free survival.