The QUILT-2.005 trial enrolled 366 patients and compares ANKTIVA plus BCG with BCG alone.
An FDA-requested interim analysis found a statistically significant longer duration of complete response with the combination, according to ImmunityBio.
The company expects to report topline results in November 2026 and submit an sBLA to the FDA in Q4 2026 to seek an expanded indication for ANKTIVA.
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