ImmunityBio (IBRX) said Monday its phase 2/3 trial of Anktiva plus Bacillus Calmette-Guerin in adults with BCG-unresponsive non-muscle invasive bladder cancer, with or without papillary disease, showed prolonged complete response and a relatively higher rate of cystectomy avoidance.
The trial results, presented at the American Urological Association Annual Meeting in Las Vegas between April 26-29, showed a 71% complete response rate, with response duration lasting up to 53 months in carcinoma in situ with or without papillary disease. The cystectomy avoidance rate was 84% at 36 months.
In patients with BCG-unresponsive non-muscle invasive bladder cancer papillary disease without carcinoma in situ, the disease-free survival rate at 12 months reached the primary endpoint of 58.2%. The cystectomy avoidance rate was 82% at 36 months, the company said.
ImmunityBio also noted that the therapy was well tolerated across cohorts, with 3% of patients experiencing grade 3 adverse events, including dysuria, pollakiuria, hematuria, and micturition urgency.
Following the study findings, the company has filed a supplemental Biologics License Application with the US Food and Drug Administration.
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