Bladder Cancer

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.

Overall survival was 100% at 12 months and 98% at 18 months among patients with MIBC who remained ctDNA-negative on serial monitoring.

"In this follow-up analysis of the phase 3 study, we demonstrated a sustained response to Adstiladrin treatment over 3 years, allowing more than half of the patients in the study to remain cystectomy free for at least 36 months,” says Colin P.N. Dinney, MD.

"We concluded based on our 36-month evaluation that nadofaragene was an option for patients who had BCG-unresponsive disease," says Colin P.N. Dinney, MD.