All News

"What was great about this partnership is we recognized that this is going to be the future of medicine at some point, and we want to be able to be a part of that cutting edge technology," says Nitin K. Yerram, MD.

The FDA has issued a complete response letter to ImmunityBio regarding its biologics license application for N-803 (Anktiva) for use in combination with BCG for the treatment of patients with non–muscle-invasive bladder cancer.

"Proxies for social determinants of health that we found to be associated with higher overall mortality included living in a more deprived area, as well as having Medicaid or Medicare insurance," says David Miller, MD.

The methylation-based urine test is performed on a qPCR platform and is intended for use in conjunction with cystoscopy.

Preliminary findings from the single-arm, phase 2 CORE-001 trial showed that the combination of the oncolytic immunotherapy cretostimogene grenadenorepvec (CG0070) and pembrolizumab (Keytruda) elicited a high complete response rate in patients with BCG–unresponsive non–muscle invasive bladder cancer.

“The results of the study imply that UGN-101 is not only a renal-preserving therapy for UTUC in this comorbid population, but could potentially delay the time to dialysis or radical nephroureterectomy," says Kyle M. Rose, MD.

The guideline updates span non-metastatic upper tract urothelial carcinoma, female stress urinary incontinence, urethral stricture disease, and prostate cancer.

"Our findings underscore the commercial and market factors that have been influencing bladder cancer care," says Brian Chun, MD.

Shilpa Gupta, MD, shares her expert insight on the evolving treatment paradigm for patients with muscle-invasive bladder cancer, along with obstacles that must be overcome to further advance the field.

"Our preliminary clinical trial found that TAR-200 was generally safe, well tolerated, and had beneficial effects on bladder cancer outcomes in a group of patients with limited treatment options," said Mark Tyson, MD, MPH.

The investigators identified several genetic factors, including ARID1A mutation, that correlated with survival outcomes in patients with advanced urothelial carcinoma treated with immune checkpoint blockade.

The current study is welcome news as it lends further support to the use of intravesical Gem/Doce as a safe and effective option that has the potential to become a new standard of care for high-risk NMIBC.

The approval of pembrolizumab plus enfortumab vedotin in urothelial cancer was supported by results from the EV-103/KEYNOTE-869 trial.

No CxM-negative patients had findings of a recurrent tumor on a follow-up cystoscopy.

The investigators used data from the National Inpatient Sample database to identify 5280 patients with non-metastatic bladder cancer who underwent RC from 2016 to 2019.

“There is an urgent need for new treatment options for [patients with] urothelial carcinoma, many of whom find themselves out of options after progressing on immune checkpoint inhibitors," said Sergio Santillana, MD.

An exploratory analysis of the IMvigor130 study failed to show an improvement in overall survival with atezolizumab, compared with placebo plus platinum-based chemotherapy and gemcitabine in patients with untreated locally advanced or metastatic urothelial cancer.

Treatment with nivolumab in patients with high-risk muscle-invasive urothelial carcinoma continued to improve survival, supporting its use as a standard of following radical resection.

In cohort B of the phase 2 Keynote-057 trial, pembrolizumab led to antitumor activity in patients with BCG-unresponsive, papillary high-risk non–muscle-invasive bladder cancer.

The ORR for patients was 47%. Of note, ORRs were higher in patients with specific alterations compared with wild type including ERBB2 (67% vs. 44%, respectively; P = .05) and TSC1 (68% vs. 25%; P = .04).

In the the phase 2 HCRN GU 16-257 trial, 33 patients with muscle-invasive bladder cancer were eligible to forego cystectomy and continue 240-mg maintenance nivolumab monotherapy every 2 weeks for 8 cycles followed by surveillance.

“A majority of patients that present with bladder cancer do not have muscle invasive disease. They have earlier stage, non-muscle invasive, and the NCCN guidelines have detailed guidance for providers about managing those patients,” said Thomas Flaig, MD.

The noninvasive UriFind test identifies bladder cancer based on methylation detection of exfoliated cell DNA in urine.

The Uro-G single-use device arrives at a time when the FDA is actively investigating reports of infections associated with reusable cystoscopes.

Final FDA decision on approvals is still pending.

In this video, Trinity J. Bivalacqua, MD, PhD, presents the case of a 63-year-old man with history of carcinoma in situ found to have low-grade Ta non-muscle invasive bladder cancer.

Fluorescent blue light cystoscopy improves 3-year recurrence-free survival rates in patients with recurrent bladder tumors compared to white light cystoscopy, and researchers believe its use should be expanded.

"Numerous clinical studies have exhibited significantly improved tumor detection rates with BLC," write Zachary L. Smith, MD, and Norm D. Smith, MD.