Moffitt Cancer Center | Strategic Alliance Partners

“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.

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.

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.

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.

Sam S. Chang MD, MBA leads a discussion of various treatment approaches for a hypothetical case of a 74-year-old female patient with T1 bladder cancer and associated CIS, exploring the necessity of repeat resections. The conversation emphasizes the importance of personalized treatment plans, considering BCG therapy, clinical trials involving immunotherapy, and the possibility of cystectomy, while also addressing the complexities and risks associated with high-grade bladder cancer in elderly patients.

This episode focuses on the complex management of recurrent low-grade bladder tumors and highlights the limitations and challenges of current treatments, including intravesical chemotherapy and BCG, and underscores the need for better therapies and clinical trials in this area.

The various treatment approaches for NMIBC in the context of a BCG shortage, with a focus on initial cases, are shared. Urologists discuss their strategies for treating a hypothetical patient with a 3 cm bladder tumor, weighing options like perioperative chemotherapy, the importance of thorough resection, and adapting treatment protocols based on tumor characteristics and the ongoing BCG shortage.

The impact of the BCG shortage on the treatment of bladder cancer, exploring various strategies adopted by urologists to optimize patient care. The conversation highlights the importance of risk stratification in deciding treatment protocols, considering factors like tumor size, location, multifocality, and histology, as well as patient age and overall health.

Experts discuss grading, staging, and risk stratification of Non-Muscle Invasive Bladder Cancer (NMIBC). Panelists highlight differentiation between the risks of recurrence and progression, emphasizing the importance of categorizing patients into low, intermediate, and high-risk groups based on various factors, including tumor size, grade, and history of recurrence. The importance of continuous prospective observation of patients with NMIBC is emphasized.

Experts in urology discuss the importance of evaluation to accurately identify the stage and grade of NMIBC, which plays a crucial role in determining the risk category focusing on the distinction between low and high-grade tumors and the significance for each patient with NMIBC​​.

Roger Li, MD, highlights 4 studies in bladder cancer being presented at the 2023 American Urological Association Annual Meeting.

Roger Li, MD, Moffit Cancer Center, was awarded the grant to study the novel oncolytic virus drug CG0070 in patients with intermediate-risk non–muscle-invasive bladder cancer.

FACT-RNT is the first tool to measure patient reported outcomes associated with radionuclide therapy for prostate cancer.

"Patients with intermediate-risk NMIBC remain an incredibly heterogeneous group," says Wei Shen Tan, MD, PhD.

OS was also found to be prolonged in the propensity score matched analysis, with a median that was not reached in the pembrolizumab arm vs 21 months in the IRC arm.

Moffitt Cancer Center conducted the first prospective study to investigate genomic biomarkers associated with aggressive disease in African American men with prostate cancer

“These analyses illustrate the critical role for inclusion of mathematical models, evolutionary first principles and computer simulations in trial design. Unlike conventional clinical trials, this approach allows both cohort and patient-specific analyses," said Jingsong Zhang, MD, PhD.

Philippe Spiess, MD, MS, FACS, recaps several presentations from the 2022 American Urological Association Annual Meeting in New Orleans, Louisiana.

The Moffitt research team, in collaboration with scientists at Washington University in St. Louis, wanted to identify alternative resistance mechanisms to enzalutamide and abiraterone in prostate cancer patients.

“I think immunotherapy in the neoadjuvant and also in the BCG-unresponsive setting are here to stay,” says Roger Li, MD.

Prostate tumors are among the cancers for whom this novel therapy is being explored.