Top 10 bladder cancer stories of 2023

There have been huge strides made in the bladder cancer field over the last year. In honor of all these advancements, Urology Times® is highlighting our top content in bladder cancer from 2023.

There has been an abundance of news in the bladder cancer field in 2023.

FDA approves enfortumab vedotin plus pembrolizumab for urothelial carcinoma

In December 2023, the FDA approved enfortumab vedotin-ejfv (Padcev) in combination with pembrolizumab (Keytruda) for the treatment of patients with locally advanced or metastatic urothelial cancer. The approval is supported by findings from the phase 3 EV-302 trial (NCT04223856), which showed that the combination led to significant improvements in overall survival and progression-free survival compared with chemotherapy in this patient population. Read more on the approval here.

Western region of the US is associated with higher costs for radical cystectomy

Findings published in Surgical Oncology showed that radical cystectomy conducted in the Western region of the United States was found to be independently associated with higher total hospital costs (THC). Even after stratifying by year of study, the West exhibited the highest THC among all 4 regions analyzed. Read more on the findings here.

Study identifies potential biomarkers for response to immunotherapy in urothelial carcinoma

Findings from whole-exome genome sequencing of urothelial carcinoma tumor specimens identified genetic molecular subtypes that correlated with response to immune checkpoint blockade, offering potential clues to enhance precision medicine in this patient population. Specifically, investigators identified a notable correlation between ARID1A mutations and positive progression-free survival (HR, 0.43; 95% CI, 0.25-0.73; P = .002) and overall survival (HR, 0.52; 95% CI, 0.29-0.92; P = .025) outcomes following immune checkpoint blockade. Read more here.

Novel intravesical drug delivery systems explored in bladder cancer

In an interview with Urology Times, Siamak Daneshmand, MD, shared data from the phase 2b SUNRISE-1 study exploring the novel intravesical gemcitabine delivery system TAR-200 in patients with BCG-unresponsive, high-risk non–muscle-invasive bladder cancer. He also highlighted a trial exploring TAR-210, an intravesical delivery system for erdafitinib (Balversa) in bladder cancer. Read the full discussion here.

Study supports bladder-sparing treatment for patients with node-positive nonmetastatic bladder cancer

Findings from a retrospective analysis published in the Journal of Clinical Oncology suggest that all patients with node-positive nonmetastatic bladder cancer should have the option to receive bladder-sparing trimodal therapy as an alternative to radical cystectomy. Data showed that regardless of whether patients received RadRT or radical cystectomy, outcomes were similar for both overall survival (HR, 0.94; 95% CI, 0.63-1.41; P = .76) and progression-free survival (HR, 0.74; 95% CI, 0.50-1.08; P = .12). Read more on the findings here.

The potential of the microbiome to enhance bladder cancer care

In an interview with Urology Times, Laura Bukavina, MD, MPH, highlighted a session that she co-chaired at the Bladder Cancer Advocacy Network Think Tank titled, “The oncobiome: Real world applications of microbiome in bladder cancer.” Bukavina is an assistant professor of urologic oncology at Case Western Reserve University in Cleveland, Ohio. Read the full discussion here.

iRARC adoption is slow but persistent in bladder cancer

Andrew M. Wood, MD, and Nima Almassi, MD, discuss the slow but persistent adoption of total intracorporeal robot-assisted radical cystectomy in bladder cancer care.

They write, “Although a substantial learning curve exists, early level 1 evidence suggests that there is a benefit to perioperative morbidity and patient-reported outcomes. Further confirmatory studies are needed and would go a long way toward convincing more urologists to make the switch.” Read their full discussion here.

Findings support use of gemcitabine/docetaxel as alternative to BCG in IR-NMIBC

Intravesical sequential gemcitabine and docetaxel showed similar efficacy to Bacillus Calmette-Guérin (BCG) in the treatment of patients with intermediate-risk non–muscle-invasive bladder cancer, supporting the use of this regimen as an alternative to BCG in this patient population.

Study author Ashish M. Kamat, MD, MBBS, commented, "In the setting of BCG shortages, our patients need alternatives that do not deprive them of the chance of cure.” Read more on the findings here.

FDA grants priority review to frontline nivolumab-based regimen for urothelial carcinoma

In December 2023, the FDA granted a priority review designation to a supplemental Biologics License Application (sBLA) for nivolumab (Opdivo) for use in combination with cisplatin-based chemotherapy in the first-line setting for the treatment of patients with unresectable or metastatic urothelial carcinoma. The sBLA is supported by findings from the phase 3 CheckMate-901 trial (NCT03036098), which showed that the addition of nivolumab to frontline gemcitabine-cisplatin (GC), followed by nivolumab maintenance therapy, led to statistically significant and clinically meaningful improvements in overall and progression-free survival compared with GC alone in this patient population. Read more here.

LUMINOS-103 substudy of lerapolturev in NMIBC begins

The first patient with non–muscle-invasive bladder cancer was treated with Lerapolturev (PVSRIPO) monotherapy via intravesicular instillation in a substudy of the LUMINOS-103 basket trial. The substudy is focusing on the treatment in adult patients with recurrent NMIBC intended for transurethral resection of bladder tumor or cystectomy. Read more here.

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