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ImmunityBio Announces ASCO Genitourinary Cancer Symposium Presentation of Phase 2/3 Trial for BCG Unresponsive Non-Muscle Invasive Bladder Cancer CIS with 71% Complete Response Rate
QUILT 3.032 study completes planned enrollment of BCG unresponsive non-muscle invasive bladder cancer CIS cohort with 59% probability of patients maintaining
About this update from Immunitybio, Inc.
[{"type":"text","content":"\n\nQUILT 3.032 study completes planned enrollment of BCG unresponsive non-muscle invasive bladder cancer CIS cohort with 59% probability of patients maintaining complete response for at least 12 months\n\n\nOver 87.5% of patients in this study have avoided a cystectomy to date\n\n\nFDA Breakthrough Therapy designation and Accelerated Approval for ImmunityBio’s superagonist Anktiva™ N-803 in this indication\n\n\n CULVER CITY, Calif.--(BUSINESS WIRE)--\nImmunityBio, Inc., a privately-held immunotherapy company, today announced the oral presentation of “Phase II/III clinical results of IL-15RαFc superagonist N-803 with BCG in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS) patients (Cohort A)” during a session at the Genitourinary Cancers Symposium sponsored by the American Society of Clinical Oncology (ASCO).\n\nThe data showed 51 out of 72 evaluable patients (71%), with 10.7 months median follow-up, had a complete response at any time to intravesical BCG plus N-803, also called Anktiva™ (95% confidence interval), meeting the primary endpoint of the study. In addition, the study showed 59% probability of these patients maintaining a complete response for at least 12 months, with an estimated median duration of complete response of 19.2 months to date using Kaplan-Meier methods.\n\n“The high rates of complete response without serious adverse events indicates that the combination of BCG plus N-803 is a promising alternative to existing therapies and compares favorably to the other approved options valrubicin and pembrolizumab,” said presenting author Karim Chamie, M.D., Associate Professor of Urology, David Geffen School of Medicine at UCLA.\n\nNo immune-related adverse events were seen in any patients, and only 1% of patients reported treatment emergent serious adverse events, but none of which were treatment-related. Additionally, 24% of patients received additional chemotherapy and other therapies (excluding BCG) between last dose of BCG and study entry, and 100% of patients received prior BCG, thus the data support the potential for Anktiva plus BCG as a novel option for BCG unresponsive CIS, a therapeutically challenging disease. Patients with BCG unresponsive CIS disease face surgical removal of the bladder, a procedure fraught with high morbidity and mortality.\n\nBladder cancer has a high...