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Clinical Trial
. 2025 Nov;43(11):660.e1-660.e10.
doi: 10.1016/j.urolonc.2025.06.006. Epub 2025 Aug 7.

Bacillus Calmette-Guérin (BCG) in combination with PANVAC™ vs. BCG alone in adults with high-grade BCG-refractory non-muscle-invasive bladder cancer

Matthew Ho  1 , Alon Lazarovich  1 , Ragheed Saoud  2 , Aaron Dahmen  1 , Samuel Tremblay  1 , Siobhan Telfer  3 , Mahir Maruf  4 , Eric A Singer  5 , Robert E Weiss  6 , Thomas L Jang  6 , Sammy E Elsamra  6 , Maria Merino  7 , Rebecca Dolan  8 , Vladimir Valera  7 , Beatriz Walter Rodriquez  7 , Reema Railkar  7 , Sonia Bellfield  7 , Lambros Stamatakis  9 , Joanna Shih  7 , Renee N Donahue  7 , Cesar Pico Navarro  10 , Andrea B Apolo  7 , James L Gulley  7 , Jeffrey Schlom  7 , Piyush K Agarwal  11
Affiliations
Clinical Trial

Bacillus Calmette-Guérin (BCG) in combination with PANVAC™ vs. BCG alone in adults with high-grade BCG-refractory non-muscle-invasive bladder cancer

Matthew Ho et al. Urol Oncol. 2025 Nov.

Abstract

Purpose: We postulated that PANVAC™, a recombinant poxviral vector vaccine, could enhance the immunologic and clinical response to an additional induction course of bacillus Calmette-Guérin (BCG) in patients with recurrent high-grade non-muscle-invasive bladder cancer (NMIBC).

Methods: This was a randomized, open-label, prospective, phase II study in subjects with high-grade NMIBC who had failed at least 1 induction course of intravesical BCG. Patients were randomized to either BCG alone or BCG+PANVAC. All subjects received intravesical BCG for 6 weeks. Patients in the combination arm also received priming and booster doses of PANVAC. The primary endpoint was recurrence-free survival. Secondary endpoints included progression-free survival and radical cystectomy-free survival. We also evaluated exploratory secondary immunological response endpoints.

Results: Our study concluded based on preplanned futility analysis. Overall, 32 patients were enrolled; 2 withdrew. Thirty patients (15/arm) were analyzed; 5 (33.3%) in the BCG-alone arm and 5 (33.3%) in the BCG+PANVAC arm met criteria for BCG- unresponsive disease. 12-month recurrence-free survival was 53.3% for the BCG-alone arm and 40% for the BCG+PANVAC arm. Overall recurrence rate at any time point was 73.3% at a median of 10.8 months, for an overall recurrence rate of 66.7% in the BCG-alone arm and 80% in the BCG+PANVAC arm. There was no difference in median recurrence-free survival or progression-free survival.

Conclusions: This phase II study demonstrated no improvement in recurrence-free survival with BCG+PANVAC compared to BCG alone in patients with NMIBC who failed to respond to intravesical BCG.

Keywords: BCG; Non-muscle invasive bladder cancer; PANVAC™.

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Conflict of interest statement

Declaration of competing interest EAS disclosures are up to date on the ASCO website. SJB is employed by Astellas.

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