Immunitybio Inc（IBRX）资讯与事件IBRXImmunitybio Inc

ImmunityBio Completes Database Lock for QUILT-2.005

ImmunityBio announced completion of the database lock for Cohort A of QUILT-2.005, its randomized, controlled, registrational trial evaluating ANKTIVA in combination with Bacillus Calmette-Guerin versus BCG alone in patients with BCG-naive NMIBC. The chemotherapy-free combination is delivered directly into the bladder. The database lock follows the completion of the data review, verification, and reconciliation of all 366 randomized patients, allowing the final efficacy analysis to proceed. The trial is designed to determine whether adding ANKTIVA to standard BCG therapy improves CR rates compared with BCG alone. An interim analysis requested by the U.S. Food and Drug Administration demonstrated statistically significant longer duration of complete response with ANKTIVA plus BCG compared to BCG alone. With the database lock complete for all patients enrolled, the final analysis is now underway and will assess the trial's primary endpoint and key secondary endpoints, including the duration of response, in accordance with the prespecified statistical analysis plan. ImmunityBio anticipates reporting topline results in November 2026 and remains on track to submit an sBLA to the FDA in the fourth quarter of 2026 for ANKTIVA plus BCG in patients with BCG-naive NMIBC. Cohort A completed enrollment in February 2026, with 366 patients randomized to receive ANKTIVA plus BCG versus BCG alone. In March 2026, following a protocol-specified interim review of the data from 183 evaluable patients, the Independent Data Monitoring Committee determined that the enrolled population provided sufficient statistical power to detect the prespecified clinically meaningful difference between treatment arms, with no additional enrollment required.

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ImmunityBio Publishes Long-Term Data from QUILT-3.032 Study

ImmunityBio announced the publication of long-term data from the Phase 2/3 QUILT-3.032 study in the Journal of Urology. The study evaluated ANKTIVA in combination with Bacillus Calmette-Guerin in patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary disease. Highlights: 71% complete response rate in patients with BCG-unresponsive NMIBC CIS, with or without papillary disease; Median duration of CR of 26.6 months, with responses extending beyond 53 months; More than half of responding patients in the FDA-reviewed population maintained complete responses beyond 45 months; 84% cystectomy-free survival at 36 months among responders; 98.2% disease-specific survival at three years; No Grade 4 or Grade 5 treatment-related adverse events reported. "The QUILT-3.032 study represents one of the longest follow-up data sets in BCG-unresponsive NMIBC to date, and the results continue to support the durability of ANKTIVA's unique mechanism of action in generating sustained immune responses," said Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. "These long-term findings are encouraging, suggesting the potential for prolonged disease control and the possibility of avoiding or delaying radical cystectomy for some patients." The publication also reported: 63.8% of responders maintained CR for at least 12 months; 52.3% maintained CR for at least 24 months; 44.2% maintained CR for at least 36 months; Progression-free survival remained 80.9% at three years; In BCG refractory patients, the CR rate was 66%; 4% of responders progressed to muscle-invasive disease. The treatment continued to demonstrate a favorable safety profile. Most treatment-related adverse events were Grade 1 or Grade 2 and consisted of localized bladder symptoms associated with intravesical therapy. Grade 3 treatment-related adverse events occurred in 4% of patients, with no Grade 4 or Grade 5 treatment-related adverse events reported.