Bladder Cancer

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.

“The actions taken by those matched over 80% of the time. It seemed like what they saw, knowing the history, was a reasonable approximation of what an in-person urologist would do,” says Tracey L. Krupski, MD.

“I think in actuality it's going to have to be one of our trained APPs going to these sites on a scheduled day, like the third Wednesday of every month,” says Tracey L. Krupski, MD.

“The hope is that we can collaborate with folks who might be interested in trying nadofaragene plus something else, something that compliments the mechanism of action, so that we can build upon what we have now,” says Vikram M. Narayan, MD.

"Because it takes advantage of a viral vector and is delivered as a gene therapy product, what it can do is it can have sustained release of IFNα2b in the bladder," says Vikram M. Narayan, MD.

"Our study showed that regardless of race, BLC increases the detection of bladder cancer when combined with WLC," says Sia Daneshmand, MD.

The sBLA is supported by findings from the phase 3 EV-302 trial, which showed that EV/pembrolizumab extended overall survival and progression-free survival vs platinum-based chemotherapy in patients with advanced urothelial carcinoma.

“The 1 tweak that's different for our model is that the trained urologist is watching the cysto at the same time as the nurse practitioner is doing it,” says Tracey L. Krupski, MD.

The application for UGN-102 for low-grade intermediate-risk non–muscle-invasive bladder cancer is based on findings from the phase 3 ENVISION trial.

"From a usage perspective, it's going to be very easy for urologists or even for labs to transition from urine cytology over to using Oncuria because it's the same practice," says Dave Mori.

The approval is based on data from the phase 3 CheckMate-901 trial, which demonstrated improved overall survival and progression-free survival with the nivolumab-combination therapy vs cisplatin/gemcitabine alone.

Data showed that the combination of EV and pembrolizumab extended overall survival and progression-free survival vs chemotherapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma.

The CMS payment rate for the tests went into effect on January 1, 2024.

In this interview, Mark D. Tyson, MD, MPH, discusses TAR-200 and other novel investigational treatments for non–muscle-invasive bladder cancer.

“With 2 years of follow-up, we saw that there was no difference in these 2 groups in terms of overall survival, metastasis-free survival, or recurrence-free survival,” says Saum B. Ghodoussipour, MD.