Urologic oncology · 2025
Bacillus Calmette-Guérin (BCG) in combination with PANVAC™ vs. BCG alone in adults with high-grade BCG-refractory non-muscle-invasive bladder cancer.
СтатьяКлиническое исследование II фазыРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Ho Matthew, Lazarovich Alon, Saoud Ragheed, Dahmen Aaron, Tremblay Samuel, Telfer Siobhan, Maruf Mahir, Singer Eric A, Weiss Robert E, Jang Thomas L, Elsamra Sammy E, Merino Maria, Dolan Rebecca, Valera Vladimir, Rodriquez Beatriz Walter, Railkar Reema, Bellfield Sonia, Stamatakis Lambros, Shih Joanna, Donahue Renee N, Navarro Cesar Pico, Apolo Andrea B, Gulley James L, Schlom Jeffrey, Agarwal Piyush K
Аннотация
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.
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.