ImmunityBio Announces Resubmission of Supplemental BLA to the FDA for ANKTIVA® Plus BCG in BCG-Unresponsive NMIBC with Papillary Disease Following Agency Review of Additional Data

Core Viewpoint - ImmunityBio has resubmitted its supplemental Biologics License Application (sBLA) for ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary tumors, following FDA's request for additional data [1][2][11] Group 1: FDA Interaction and Resubmission - The resubmission of the sBLA follows ongoing discussions with the FDA that began in January 2026, where the FDA requested additional data to support the review without requiring new clinical trials [2][11] - The FDA acknowledged receipt of the resubmitted sBLA, which includes updated long-term follow-up data for patients with papillary-only NMIBC [2][11] Group 2: Clinical Data and Efficacy - Long-term results from the QUILT 3.032 Phase 2/3 trial demonstrated a 12-month disease-free survival (DFS) rate of 58.2% in 80 patients with high-grade papillary-only NMIBC [5] - The study reported a 96.0% disease-specific survival (DSS) rate at 36 months and a progression-free survival (PFS) of 94.9% at 12 months, indicating durable prevention of progression to muscle-invasive disease [5] - Cystectomy-free survival was reported at 92.2% at 12 months and 81.8% at 36 months, suggesting that over 80% of patients avoided radical cystectomy through three years of follow-up [5] Group 3: Mechanism of Action and Regulatory Insights - ANKTIVA's mechanism of action as an IL-15 superagonist was affirmed by the FDA's previous approval in 2024 for BCG-unresponsive NMIBC with carcinoma in situ [3] - The recent approval by the Saudi Food and Drug Authority (SFDA) for ANKTIVA in combination with checkpoint inhibitors for metastatic non-small cell lung cancer (NSCLC) highlights its potential in addressing unmet medical needs in this patient population [3][4] Group 4: Company Overview and Future Plans - ImmunityBio focuses on developing next-generation immunotherapies that activate the immune system to provide durable protection against cancer and infectious diseases [12] - The company plans to present clinical data supporting the SFDA approval and continue discussions with the FDA regarding treatment options for patients with metastatic NSCLC who have exhausted current standards of care [4][12]