Bladder Cancer

N-803 was approved by the FDA in April 2024 for the treatment of patients with BCG-unresponsive NMIBC carcinoma in situ with or without papillary tumors.

Cretostimogene grenadenorepvec is an intravesical oncolytic immunotherapy currently under investigation in phase 3 trials.

The 12-month duration of response was 82.3% among patients with LG-IR-NMIBC who achieved a complete response at 3 months following the first UGN-102 instillation.

Gary D. Steinberg, MD, analyzes data from the BOND-003 study presented at AUA 2024, which investigated the use of intravesical cretostimogene grenadenorepvec for treating high-risk, BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, and discusses the mechanism of action of this novel oncolytic viral therapy.

"We found that, in our study, approximately 25% of patients who have had opioids prior to their cystectomy will continue to use opioids 3 to 6 months after their surgery," says Christopher J. Staniorski, MD.

“CORE-001’s excellent efficacy, long-term durability of response, and favorable benefit-to-risk-ratio profile seen with combination cretostimogene and pembrolizumab suggest the potential for a novel bladder-sparing therapy in the BCG-unresponsive NMIBC setting,” said Roger Li, MD.

Expert urologist explores potential treatments for BCG-unresponsive intermediate and high-risk non-muscle-invasive bladder cancer (NMIBC), including immune checkpoint inhibitors, oncolytic viral therapy, cytokine agonists, immunomodulators, and the recently approved drugs pembrolizumab and nogapendekin alfa inbakicept-pmln.

Gilead reported that a numerical improvement in OS favoring sacituzumab govitecan was observed, though the end point was not reached in the intent-to-treat population.

Gary D. Steinberg, MD, discusses the unmet needs and current standard of care for patients with intermediate and high-risk non-muscle-invasive bladder cancer (NMIBC).

The approval is based on findings from the phase 3 CheckMate-901 study.

"I think [these are] important data to [give to] your patients," says Laura Bukavina, MD, MPH.

“One of the biggest things that this brings us to for an update of upper tract disease is biopsy alone of an upper tract tumor is not good enough anymore--we must risk stratify these patients,” says Katie S. Murray, DO.

"In [bladder cancer], many women's diagnosis is delayed because their hematuria or microscopic hematuria is blamed on urinary tract infections rather than cancer," says Amy Luckenbaugh, MD.

"Our first question is, in patients who were on the GLP1R agonists for a prolonged period of time, were those patients at increased or decreased risk of developing the most common GU malignancies?" says Laura Bukavina, MD, MPH.

RAG-01 is an saRNA therapy that is delivered via intravesical instillation and is designed to target and activate p21, a tumor suppressor gene.

“But more importantly, there are patients who have no insurance, there are patients who have no other resources and are maybe even on the poverty line. We feel, importantly, that we have an obligation that the drug be made free for these patients in the United States,” says Patrick Soon-Shiong, MD.

“All this is very detailed immunology, I get that, but it sets the stage for what I consider the next evolution of immunotherapy,” says Patrick Soon-Shiong, MD.

"There's definitely more work to do to confirm these results on a multi-institutional aspect," says Ryan L. Steinberg, MD.

"Ultimately, we found that in this retrospective evaluation, there was no significant difference in recurrence-free survival in those who are treated with gemcitabine and docetaxel as compared to BCG," says Ryan L. Steinberg, MD.

“There is great interest in looking at all these targeted interventions in the earlier stages to lower the burden of care that patients go through and to some degree that urologists and other health care professionals in this in this realm go through,” says Surena F. Matin, MD.

“What we find here was that of the patients who had FGFR3 alterations, 67% of them had tumors that responded,” says Surena F. Matin, MD.

The clearance of the IND application for RAG-01 will initiate the launch of clinical trials in the US.

A decision regarding EU marketing authorization is expected by June 2024.

"And [3 out of 5] of those patients who were initially deemed to go on to nephroureterectomy were able to be converted to endoscopic management," says Surena F. Matin, MD.

The approval is supported by findings of the ongoing QUILT-3.032 trial, assessing nogapendekin alfa inbakicept (N-803) plus BCG in patients with BCG-unresponsive non–muscle-invasive bladder cancer.

The 3 new additional studies are the ABLE-22, ABLE-32, and ABLE-42 clinical trials.

The IND will initiate the launch of a phase 3 study to explore the safety and efficacy of UGN-103 in patients with low-grade, intermediate-risk NMIBC.

“In the preclinical space, we continue to be interested in trying to understand the mechanistic underpinnings of these combination therapies,” says Kent W. Mouw, MD, PhD.

"This encouraging anti-tumor activity coupled with a favorable safety profile and mode of administration that is both convenient and familiar to urologists indicates that, if confirmed in future studies, TARA-002 could potentially play a meaningful role in NMIBC treatment in the future," says Timothy D. Lyon, MD.