Bladder Cancer

An analysis, based on data from the JAVELIN 100 Bladder trial, found the NCCN/FACT Bladder Symptom Index-18 for assessing quality-of-life in patients with advanced urothelial carcinoma to be reliable and valid.

Arlene O. Siefker-Radtke, MD, discusses the results of the phase 3 THOR study of erdafitinib vs pembrolizumab in pretreated patients with advanced or metastatic urothelial cancer with select FGFR alterations.

With an investigational new drug granted to ZH9 by the FDA, a clinical development program for the treatment of patients with non-muscle invasive bladder cancer can be initiated.

The combination of sacituzumab govitecan-hziy and enfortumab vedotin-ejfv showed early responses in patients with treatment-resistant metastatic urothelial cancer.

In an interview with Targeted Oncology, Brian Ramnaraign, MD, further discussed the safety of immune checkpoint inhibitors in patients with genitourinary cancers.

After issuing a complete response letter in May 2023, the FDA has now accepted the resubmission of the biologics license application of a drug regimen for the treatment of non-muscle-invasive bladder cancer.

A phase 2 study of neoadjuvant gemcitabine, cisplatin, plus nivolumab met its co-primary end point with a positive predictive value of clinical complete response of 0.97 among patients with muscle-invasive bladder cancer.

Over three-fourths of patients with BCG-unresponsive, high-risk non–muscle-invasive bladder cancer treated with TAR-200 achieved complete responses in the phase 2b SUNRISE-1 trial.

Enfortumab vedotin-ejfv plus pembrolizumab improves survival in patients with previously untreated locally advanced or metastatic urothelial carcinoma.

The addition of nivolumab to frontline standard of care gemcitabine-cisplatin, followed by nivolumab maintenance therapy, led to statistically significant and clinically meaningful improvements in survival compared with gemcitabine-cisplatin alone in patients with unresectable or metastatic urothelial carcinoma.

Thomas Powles, MD, MBBS, MRCP, discusses findings from the phase 3 EV-302 clinical trial of enfortumab vedotin-ejfv with pembrolizumab vs chemotherapy for the treatment of patients with previously untreated locally advanced or metastatic urothelial cancer.

A post hoc analysis of overall survival and progression-free survival support the use of avelumab with best supportive care as a standard of care for patients with urothelial carcinoma.

Findings from the CheckMate-901 trial demonstrated improvements for the treatment of patients with urothelial carcinoma who received a combination of nivolumab and chemotherapy followed by nivolumab monotherapy.

Siamak Daneshmand, MD, discusses TAR-200 and what led investigators to evaluate the agent in the phase 2b SunRISE-1 study.

Meeting a primary end point, KEYNOTE-123 study shows promise for pembrolizumab as an adjuvant muscle-invasive bladder cancer treatment.

The ADVANCED-2 trial plans to build onto the early antitumor and safety data seen with TARA-002 that were presented this year for patients with non-muscle invasive bladder cancer.

Seagen Inc., and Astellas Pharma Inc., report that both primary end points of the phase 3 EV-302 clinical trial have been met.

In an interview with Targeted Oncology, Arlene O. Siefker-Radtke, MD, discusses the findings from 3 trials of erdafitinib and explains the next steps for evaluating the agent.

Nadofaragene firadenovec-vncg received FDA approval for patients with high-risk, BCG-unresponsive non-muscle invasive bladder cancer in 2022, and is now being evaluated further in the ABLE-41 trial.

Petros Grivas, MD, PhD, discusses the design and end points of the phase 2 KEYNOTE-057 trial.

Promising overall survival findings from cohort 1 of the THOR study evaluating erdafitinib in locally advanced or metastatic urothelial cancer have pushed the agent’s developer to submit an sNDA seeking its full approval.

A single-arm trial induced high event-free and overall survival with the addition of durvalumab to standard of care before radical surgery in patients with muscle-invasive urothelial carcinoma.

In an interview with Targeted Oncology, Daniel P. Petrylak, MD, discussed findings from the TROPHY-U-01 study for patients with mUC, and what the next steps for research are.

In an interview, Shilpa Gupta, MD, discussed findings from cohort A of Study EV-103 in patients with cisplatin-ineligible locally advanced or metastatic urothelial carcinoma.

Rohan Garje, MD, explains some of the differences between the sarcomatoid and classic carcinoma of the bladder.