Mp16-03 N-803 Plus BCG Complete Response Rate in Nmibc Cis Subjects: BCG Refractory, Relapsed, Checkpoint Failure, and Chemotherapy Failure; Updated Results (Quilt 3.032)

You have accessJournal of UrologyBladder Cancer: Non-invasive I (MP16)1 May 2024MP16-03 N-803 PLUS BCG COMPLETE RESPONSE RATE IN NMIBC CIS SUBJECTS: BCG REFRACTORY, RELAPSED, CHECKPOINT FAILURE, AND CHEMOTHERAPY FAILURE; UPDATED RESULTS (QUILT 3.032) Patrick Soon-Shiong, Sandeep Reddy, and Karim Chamie Patrick Soon-ShiongPatrick Soon-Shiong , Sandeep ReddySandeep Reddy , and Karim ChamieKarim Chamie View All Author Informationhttps://doi.org/10.1097/01.JU.0001008640.01272.9d.03AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Patients with NMIBC CIS unresponsive to BCG have limited treatment options. N-803 (Anktiva) is a mutant IL-15-based immunostimulatory fusion protein complex (IL15RaFc) that promotes proliferation and activation of natural killer (NK) cells and CD8+ T cells, but not regulatory T cells. An open-label, 3 cohort multicenter study (QUILT 3.032) of intravesical BCG plus N-803 in patients with BCG-unresponsive high-grade NMIBC (NCT03022825) was opened. We report on the duration of response and the CR rate of subjects with BCG refractory, relapsed, checkpoint-failure, and chemotherapy-failure in 94 BCG-unresponsive CIS subjects. METHODS: All treated patients received intravesical N-803 plus BCG, consistent with the standard induction/maintenance treatment schedule. The primary endpoint for CIS is incidence of complete response (CR) of CIS at any time. The subset analyses were pre-planned per protocol. RESULTS: All CIS subjects received prior BCG, the median number of prior BCG doses received was 12.0 doses (range, 5 to 48 doses). The median time from last prior BCG dose to first documented CIS disease recurrence was 2.46 months (range, 0.7 to 11.1 months). Forty-eight (48) subjects received additional prior therapy including chemotherapy and checkpoint therapy, in addition to prior BCG therapy. In this highly pretreated group, 31 out of 48 had a CR of 65% (49.5, 77.8). With regard to prior BCG therapy, seventy-four (74) subjects received ≥12 prior BCG doses. In this group, 51 out of 74 had a CR, yielding a CR rate of 69% (57.1, 79.2), and 14/20 subjects who received 12 months and 53.2% had a duration of >24 months. CONCLUSIONS: N-803 plus BCG results in a high CR rate in subjects who failed both BCG and other therapies, including additional BCG, chemotherapy and checkpoint inhibitors, with a median duration of response of >28 months. Source of Funding: ImmunityBio © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e240 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Patrick Soon-Shiong More articles by this author Sandeep Reddy More articles by this author Karim Chamie More articles by this author Expand All Advertisement PDF downloadLoading ...