Noticias y eventos de Immunitybio Inc (IBRX)IBRXImmunitybio Inc

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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.

ImmunityBio's ANKTIVA Receives Expanded FDA Indication

ImmunityBio announced that the U.S. Food and Drug Administration has expanded the approved indication for ANKTIVA in combination with Bacillus Calmette-Guerin to include patients with BCG-unresponsive NMIBC with papillary-only tumors. The expanded FDA label reads as follows: ANKTIVA, in combination with Bacillus Calmette-Guerin, is indicated for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer. "This approval marks an important expansion of ANKTIVA plus BCG for patients with BCG-unresponsive NMIBC and advances our goal of harnessing the patient's own immune system to achieve durable, tumor-free outcomes," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. "An important first step as we develop Immunotherapy 2.0."