On April 1, 2022 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported that it has achieved a major milestone with over 80 subjects in the QUILT-3.032 study completing at least 12 months of follow-up as of January 14, 2022 (Press release, ImmunityBio, APR 1, 2022, View Source [SID1234611346]). All data for QUILT-3.032, which is studying VesAnktivaä plus BCG in subjects with BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ (NMIBC CIS), have been locked and analyzed. The results continue to demonstrate a clinically meaningful benefit that is sustained. The BLA has been compiled and, following final quality review, is expected to be submitted to the U.S. Food and Drug Administration (FDA) this month. The FDA granted Fast Track Designation to the pivotal trial based on Phase I data. In December 2019, the FDA granted ImmunityBio Breakthrough Therapy Designation (BTD) based on interim Phase 2 data indicating the primary endpoint of the trial was already met.

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"We are excited to announce that the comprehensive compilation of our BLA is essentially written," said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. "With 71% of the participants in this study having a complete response and a median duration of response of 26.6 months, we believe we have a clinically meaningful therapeutic alternative for patients suffering from NMIBC in which the only option remaining is total cystectomy."