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Addition of N-803 Results in Efficacy, Safety in NMIBC CIS Unresponsive to BCG

Patients with Bacillus Calmette-Guerin (BCG)–unresponsive, non-muscle invasive bladder cancer (NMIBC) carcinoma in-situ (CIS) who were treated with N-803 (also known as ALT-803) added to BCG Vaccine experienced promising response rates and a tolerable safety profile, according to data presented at the 2021 Genitourinary Cancers Symposium.1

The findings, taken from cohort A of the phase 2/3 QUILT-3.032 trial (NCT03022825), showed that at a median follow-up of 10.7 months, 71% of evaluable patients (n = 51/72) achieved a complete response (CR) at any time (95% CI, 59%-81%), meeting the primary end point of the study.

Moreover, investigators reported a 56% probability of maintaining a CR with this approach at 12 months (95% CI, 38.8%-70.3%). Among responders, the estimated median duration of CR was 19.2 months (95% CI, 7.3–not reached [NR]). Notably, the majority of patients, or…

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