ImmunityBio Announces FDA Acceptance of Biologics License Application for N-803 in BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer Carcinoma In Situ
Friday, July 29, 2022
The FDA has accepted ImmunityBio, Inc.'s Biologics License Application (BLA) for review. The BLA pertains to an antibody cytokine fusion protein intended for the treatment of BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or without Ta or T1 disease. ImmunityBio, a prominent clinical-stage immunotherapy company, submitted the BLA based on positive outcomes from various studies, including the ongoing QUILT 3.032 trial. The Prescription Drug User Fee Act (PDUFA) target action date has been set for May 23, 2023.
If approved, this combination of N-803 with BCG would be ImmunityBio's first immunotherapy combination to reach this stage of FDA review. This milestone represents a significant step forward in ImmunityBio's mission to transform cancer treatment by activating the patient's innate immune system, eliminating the need for high-dose chemotherapy. Notably, N-803 plus BCG would be the first immunotherapy combination for this indication in 23 years that can be directly delivered to the bladder (intravesically), stimulating natural killer cells and T cells. This achievement aligns with the Nant Cancer Vaccine hypothesis proposed by ImmunityBio's founder, Patrick Soon-Shiong, M.D., titled "Quantum oncotherapeutics: a longitudinal spatiotemporal orchestration towards immunogenic cell death."
N-803 operates through a unique mechanism of action that promotes the proliferation of NK and T cells, which are essential components of the adaptive and innate immune system. By doing so, N-803 enhances the immunological response triggered by BCG for bladder cancer or by a checkpoint inhibitor for other indications. In the QUILT 3.032 study, 71% of patients who had previously failed on other therapies exhibited a response rate and median duration increase of over 50% compared to FDA-approved alternatives such as Valrubicin and Pembrolizumab, a systemic checkpoint inhibitor therapy for this indication.
Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio, expressed enthusiasm regarding the BLA acceptance, highlighting the potential of this combination therapy to benefit more individuals with NMIBC and potentially reduce the need for cystectomies. He emphasized the power of inducing trained innate immune memory to offer long-term, durable effects against life-threatening diseases.
Richard Adcock, President and CEO of ImmunityBio, conveyed the company's satisfaction with the FDA's initiation of the review process. ImmunityBio is well-prepared to proceed with manufacturing and marketing should the therapeutic gain approval for this indication.
The BLA submission draws support from ImmunityBio's bladder cancer trials, including the QUILT 3.032 study—an open-label, multicenter Phase 2/3 trial with three cohorts—evaluating intravesical BCG plus N-803 in BCG-unresponsive high-grade NMIBC patients (NCT03022825). The primary endpoint for Cohort A of this study is the incidence of complete response (CR) of CIS at any time. Trial results were presented at the 2022 American Society of Clinical Oncology Annual Meeting (ASCO 2022).
