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ImmunityBio Announces Primary Endpoint Met in a Second Indication in Bladder Cancer Trial with 57% Disease-Free Survival in Patients with BCG Unresponsive Papillary Disease
Primary endpoints were met for both Cohorts A and B of Carcinoma in Situ (CIS) and Papillary disease in the 154-patient Phase 2/3 trial studying Anktiva
About this update from Immunitybio, Inc.
[{"type":"text","content":"\n\nPrimary endpoints were met for both Cohorts A and B of Carcinoma in Situ (CIS) and Papillary disease in the 154-patient Phase 2/3 trial studying Anktiva (N-803) and BCG in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC)\n\n\nIn papillary disease, 57% of patients remain disease free at 12-months and with CIS disease complete response rate is 72%\n\n\nThere were zero immune- or treatment-related severe adverse events noted in the combined safety analysis of 154 patients in the trial\n\n\nKey patent allowed covering Anktiva intravesical use in bladder cancer with the term extending to 2035\n\n\n CULVER CITY, Calif.--(BUSINESS WIRE)--\nImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced that Papillary disease (Cohort B), the second indication of its QUILT 3.032 Phase 2/3 study of intravesical BCG plus Anktiva in patients with BCG-unresponsive high-grade NMIBC (NCT03022825), also met its primary endpoints with disease-free survival of 57% of patients at 12 months. The company has previously reported that the primary endpoint of Cohort A, patients with CIS disease, has been met with a complete response of 72% (58/81).\n\nNon-muscle invasive bladder cancer (NMIBC) makes up 75%-85% of all bladder cancers in the U.S.; approximately 90% of NMIBC cases are papillary (stages Ta and T1). Current standard of care for high-grade papillary disease is intravesical BCG, with a 40% non-response rate.\n\nTo date, 73 patients have enrolled in Cohort B with a median follow-up of 17.3 months. The primary endpoint was met with a disease-free rate at 12-months of 57% (95% CI: 43.7%, 68.5%) and at 18-months, 53% (95% CI: 38.8%, 64.6%) by Kaplan-Meier analysis. Durable responses were noted in both cohorts and the therapy resulted in significant avoidance of cystectomy.\n\nThe safety profile of Anktiva (N-803) in Cohort B was consistent with that seen in Cohort A, which was recently presented at the American Urological Association’s 2021 Annual meeting, in which 0% SAEs, including 0% immune-related SAEs, were detected. In addition, 85% of the patients were able to avoid a cystectomy. A full analysis of efficacy and safety data for both Cohorts A (CIS) and B (Papillary) has been submitted to the American Society of Clinical Oncology Genitourinary Cancer Symposium (ASCO GU) in February 2022.\n\n“Intravesi...