Bladder Cancer

Findings presented during the 2023 ESMO Annual Meeting have demonstrated a new combination of targeted therapies offering clinicians and patients renewed hope in this difficult to treat cancer type.

Positive data from the phase 3 EV-302 trial of enfortumab vedotin with pembrolizumab in locally advanced or metastatic urothelial cancer have shifted the landscape.

BCG-unresponsive non-muscle invasive bladder cancer risks invasive progression; providers should suspect disease based on any abnormalities in cystoscopy and cytology, not just voiding symptoms.

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.

Jonathan E. Rosenberg, MD, explains the study design and patient inclusion criteria of the phase 2 EV-103 study investigating combination enfortumab vedotin plus pembrolizumab for the treatment of patients with metastatic or locally advanced urothelial carcinoma.

Jonathan E. Rosenberg, MD, joins the Oncology Brothers, Rohit Gosain, MD, and Rahul Gosain, MD, in reviewing the results of the EV-103 study in patients with metastatic or locally advanced urothelial carcinoma.