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Treatment had a favorable safety profile: most treatment-related adverse events were Grade 1 or 2 localized bladder symptoms, Grade 3 occurred in 4% of patients, and no Grade 4 or 5 treatment-related events were reported.
60% confidenceANKTIVA plus BCG showed a 71% complete response rate, median CR duration of 26.6 months with responses beyond 53 months, and more than half of responders in the FDA-reviewed population maintained CR beyond 45 months.
60% confidenceQUILT-3.032 is one of the longest follow-up data sets in BCG-unresponsive NMIBC to date and supports the durability of ANKTIVA's mechanism of action in generating sustained immune responses; findings suggest potential for prolonged disease control and avoiding or delaying radical cystectomy for some patients.
60% confidencePeer-reviewed results add to the growing body of evidence supporting ANKTIVA plus BCG and highlight potential for sustained disease control and cystectomy avoidance for patients with limited options.
60% confidence