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NEJM Evidence Publishes Results for ImmunityBio’s QUILT 3.032 Registrational Trial of IL-15 Superagonist N-803 Plus BCG in Patients with Bladder Cancer
Primary endpoint met in high-risk carcinoma in situ (CIS) cohort with 71% complete response rate (CR) with a median duration of response of 26.6 months, a
About this update from Immunitybio, Inc.
[{"type":"text","content":"\n\nPrimary endpoint met in high-risk carcinoma in situ (CIS) cohort with 71% complete response rate (CR) with a median duration of response of 26.6 months, a 53% CR rate at 24 months and a safety profile comparable to BCG alone\n\n\nThis novel IL-15 superagonist N-803 – referred to as nogpendekin alfa inbakicept (NAI) in the manuscript - acts synergistically with BCG with a 90% probability of avoiding cystectomy over 24 months in responders\n\n\nPrimary endpoint also met in papillary non-muscle invasive bladder cancer (NMIBC) cohort with 55% remaining disease free at 12 months\n\n\nThe Food and Drug Administration (FDA) is currently reviewing the Biologics License Application (BLA) for N-803 plus BCG for the treatment of NMIBC CIS with a Prescription Drug User Fee Act (PDUFA) date of May 23, 2023\n\n\n CULVER CITY, Calif.--(BUSINESS WIRE)--\nNEJM Evidence has published results from the QUILT 3.032 trial studying N-803 plus BCG in adults with NMIBC CIS with or without Ta/T1 papillary disease. These positive data form the basis of ImmunityBio’s BLA for BCG-unresponsive NMIBC CIS, which the FDA accepted for review in July 2022.\n\nThe published results demonstrate that in patients with BCG-unresponsive NMIBC CIS and papillary disease, BCG plus N-803 (referred to as NAI) CRs were achieved with a persistence of effect with 90% probability of avoiding cystectomies in responders, a life-changing procedure of removing the bladder, and 100% bladder cancer-specific survival at 24 months. This investigational therapy represents an important clinical benefit addressing an unmet need of avoiding a cystectomy in this high-risk bladder cancer population.\n\n“The peer review and publication of data in NEJM Evidence highlights the significance of the positive results of the QUILT 3.032 trial in patients with BCG-unresponsive NMIBC,” said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. “We’re targeting the 10th most commonly diagnosed cancer and the one with the highest lifetime treatment costs per patient as a result of the prolonged course of the disease and the need for repeated surgical and treatment intervention. These data further our understanding of N-803’s unique role in potentially boosting the proliferation of natural killer and T cells while synergistically enhancing BCG e...