Topline Results From Recent NMIBC Trials

EP: 1.Assessing Risk in NMIBC: A Foundation for Therapy

EP: 2.From Papillary to CIS: Tailoring NMIBC Treatment

EP: 3.Defining and Managing BCG-Unresponsive NMIBC

EP: 4.NMIBC Maintenance Therapy: Timing, Dosing, and Follow-Up

EP: 5.FDA-Approved Options for High-Risk BCG-Unresponsive NMIBC

EP: 6.An Overview Of Pembrolizumab for High-Risk BCG Unresponsive NMIBC

EP: 7.An Overview of Nogapendekin Alfa Inbakicept for High-Risk, BCG-Unresponsive NMIBC

EP: 8.Real-World Outcomes With Nadofaragene in BCG-Unresponsive NMIBC

EP: 9.Exploring Nadofaragene Firadenovec: Ongoing Trials and Study Designs

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EP: 10.Topline Results From Recent NMIBC Trials

EP: 11.Overcoming Challenges in Accessing New Therapies for NMIBC

EP: 12.Navigating Access Barriers: Resources to Support New Treatment Access

EP: 13.Reflecting on NMIBC Progress: Highlights From AUA 2025 and What’s Ahead

Physician Summary

Pembrolizumab in KEYNOTE-057 Trial (Necchi et al, 2024)
The KEYNOTE-057 trial assessed pembrolizumab in BCG-unresponsive NMIBC, showing strong complete response (CR) rates and durability. Pembrolizumab was well-tolerated, positioning it as a promising option for these patients.

Nogapendekin Alfa Inbakicept in QUILT-3.032 Trial (Chamie et al, 2023)
The QUILT-3.032 trial evaluated nogapendekin alfa inbakicept, yielding promising CR rates and durability. Safety was manageable, supporting its continued investigation.

Comparison of Results: Nadofaragene Firadenovec, Pembrolizumab, and Nogapendekin Alfa Inbakicept

• CR Rates: Pembrolizumab, nogapendekin alfa, and nadofaragene firadenovec all showed high CR rates, though in different patient populations.
• Durability: Nadofaragene firadenovec and pembrolizumab showed favorable durability.
• Safety: All three therapies had manageable safety profiles.
• Patient Selection: Pembrolizumab and nogapendekin alfa focused on BCG-unresponsive NMIBC, while nadofaragene firadenovec included a broader NMIBC population.

CORE-001 Trial: Cretostimogene Grenadenorepvec + Pembrolizumab (Li R et al., 2024)
The CORE-001 trial investigated the combination of cretostimogene grenadenorepvec with pembrolizumab, showing enhanced CR rates and immune response. Combining an oncolytic virus with a PD-1 inhibitor offers synergistic benefits, boosting immune system activity.

Novel Intravesical Therapies: TAR-200, UGN-102, UGN-103
Extended-release intravesical therapies like TAR-200, UGN-102, and UGN-103 offer sustained drug release directly in the bladder, improving efficacy, patient convenience, and compliance.

These trials explore promising therapies for NMIBC, aiming to enhance efficacy, durability, and patient quality of life.