Bladder Cancer

"Real-world data has a real place in demonstrating some of these findings and allowing us to ask better questions," says Bogdana Schmidt, MD, MPH.

"Based on the LEA and S1011 trials, it has become clear that patients do not benefit from an extended LND, and a standard bilateral pelvic LND is the standard of care," write Amir Soltani-Tehrani, MD, and Kamal S. Pohar, MD.

"An alternative off-label option for patients with BCG-unresponsive NMIBC is sequential intravesical gemcitabine and docetaxel (Gem/Doce)," write Rachel Passarelli, MD, and Vignesh T. Packiam, MD.

“Our data showed a considerable gap in reporting patient-reported outcomes and in the quality of design and conduct of patient-reported outcomes-related trial endpoints," said Jad Chahoud, MD, MPH.

ZH9 is a proprietary bacterial immunotherapy administered to patients via a single-dose intravesical induction regimen.

"The data from the QUILT 3.032 Quality of Life study suggest that many patients not only have a durable response but also report no decline in physical function, which is very important for these patients,” says Karim Chamie, MD.

“The gemcitabine/docetaxel [combination] has been the answer that many people have needed,” says Joshua J. Meeks, MD, PhD.

"There's just a lot of active trials being studied, and hopefully, in the next 5 or 10 years, we'll see another handful of agents get approved and really start to make some headway in [NMIBC]," says Alexander I. Sankin, MD.

The applications in the EU and Japan are both based on findings from the phase 3 EV-302 trial.

"I predict 2024 will be a banner year for progress in the management of [NMIBC], and not only will we be moving the needle but also turning up the volume in this historically quiet space," writes Michael S. Cookson, MD, MMHC, FACS.

The application is based on findings from the phase 2 DESTINY-PanTumor02 trial.

Conversely, investigators noted that there was an overall survival benefit when dose-dense MVAC was used in the neoadjuvant setting.

In this final episode, panelists conclude with reflections on the significant progress made in treating NMIBC over the past decade, particularly in the last 5 years. Looking ahead to 2024, experts in urology express excitement about investigational treatments (ie, cretostimogene grenadenorepvec and UGN 102), the potential for personalized medicine, emphasizing the need to understand molecular characteristics of the disease for better treatment customization. The session also highlights the importance of balancing quality of life with effective treatment strategies, and the prospect of utilizing emerging therapies early in the disease process.

This video segment explores various investigational strategies, including the use of agents like UGN 102, and recent clinical trials for intermediate-risk NMIBC. The conversation highlights the importance of balancing side effects with efficacy and the shift towards non-surgical management in treating intermediate-risk NMIBC and in the BCG-naive population.

The approval is based on results from the phase 3 THOR trial.

A phase 3 study is expected to initiate in 2024 to explore the safety and efficacy of UGN-103 in LG-IR-NMIBC.

The mHealth mobile app provides patients with incremental education on post-cystectomy recovery, delivering information at various timepoints after the patient is discharged from the hospital.

“These [patient-reported outcome] data are supportive of the use of [enfortumab vedotin plus pembrolizumab] as a 1L therapy option for patients who are cisplatin-ineligible," write the authors.

Nadofaragene firadenovec received FDA approval in December 2022 for the treatment of patients with high-risk BCG-unresponsive NMIBC with carcinoma in situ with or without papillary tumors.

This video episode discusses various new therapies and strategies for treating patients with high-risk BCG-unresponsive NMIBC. It includes a review of nadofaragene firadenovec-vncg, its FDA approval, dosing schedule, and patient response rates. The conversation also explores the practical aspects of treatment, such as the balance between efficacy and treatment frequency, and the potential sequencing of therapies in clinical practice.

This video segment provides insights into various innovative trials and agents being explored for high-risk BCG-unresponsive NMIBC. The discussion covers a range of approaches including oncolytic immunotherapy, gene therapy, systemic IO agents, antibody-drug conjugates, and cytokine therapies. It emphasizes the need for personalized dosing regimens based on individual immune responses and highlights the significance of longer-term efficacy evaluations beyond initial three-month response rates.

In total, the study plans to enroll approximately 100 BCG-unresponsive NMIBC CIS patients across 15 clinical study sites in the US and Canada.

"It's really gratifying to see how the field has changed over the last 10 years," says Daniel P. Petrylak, MD.

This episode provides an in-depth discussion on Cretostimogene Grenadenorepvec (CG), an investigational agent for high-risk BCG-unresponsive NMIBC, including the mechanism of action, its efficacy and safety data from clinical trial trials like CORE01 and BOND-003 (NCT04452591), and the rationale behind combining CG with anti-PD-1/PD-L1 antibodies. Experts also provide their insights on future directions in clinical development and application of CG in various NMIBC treatment scenarios, such as a monotherapy and in combination with IO, including its potential use in intermediate-risk disease.

This episode explores the potential of emerging therapies in providing effective treatment alternatives for challenging NMIBC cases. Current clinical trials and investigational treatments for high-risk, BCG-unresponsive NMIBC are highlighted, including the use of N-803, an IL-15 superagonist, in combination with BCG, and discusses TAR-200, an intravesical drug delivery system, which releases gemcitabine directly into the bladder over time.

Previously reported data showed promising efficacy signals and a manageable safety profile for the combination in patients with advanced solid tumors.

"When we think about a typical procedure for performing a radical cystectomy for cancer with an ileal conduit, that would typically involve lymph node dissection, and therefore CPT 51595 would be best chosen to report that combined procedure," write Jonathan Rubenstein, MD, and Mark Painter.

Data from the EV-302 trial showed a doubling of progression-free survival and overall survival with the ADC/checkpoint combination versus standard chemotherapy.

Neal Shore, MD, FACS, offers clinical insights on optimizing patient selection and treatment sequencing in BCG-unresponsive NMIBC.

This monthly series will begin in January 2024, and attendees can earn one category 1 CME credit per session.