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Topline Results From Recent NMIBC Trials

Panelists discuss how recent trials, including KEYNOTE-057, QUILT-3.032, and CORE-001, highlight the promising efficacy, durability, and manageable safety profiles of novel treatments like pembrolizumab, nogapendekin alfa inbakicept, and nadofaragene firadenovec, while also exploring the potential of combination therapies and novel intravesical options like TAR-200 and UGN-102 for improving outcomes in non–muscle-invasive bladder cancer (NMIBC).

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.

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