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News
A bladder cancer drug combo is proving its staying power. Follow-up data from the QUILT-3.032 trial show that nogapendekin alfa inbakicept (NAI) plus BCG achieved a 71% complete response rate in patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC), with a median response duration of about 2 years — and up to 53 months in the FDA-approved population. Most responders also avoided bladder removal surgery.
A bladder cancer drug combo is proving its staying power. New follow-up data from the phase 2/3 QUILT-3.032 trial show that intravesical nogapendekin alfa inbakicept (NAI) combined with BCG achieved a 71% complete response (CR) rate in 100 patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS). The median duration of response was 26.6 months overall, and in the FDA-approved population, the median CR duration exceeded 45 months — with some responses lasting up to 53 months.
Beyond tumor response, the treatment helped patients hold onto their bladders. The vast majority of responders remained cystectomy-free at 12 months (95.5%), 24 months (90.3%), and 36 months (84.2%). The safety profile was also reassuring, with only a 3% rate of grade 3 adverse events.
By the Numbers
Why it matters: For patients with BCG-unresponsive NMIBC — a notoriously difficult-to-treat population — these durable responses offer a meaningful alternative to bladder removal. Editorialists called for head-to-head comparative trials and biomarker research to better guide treatment selection going forward.
