ImmunityBio: PROs IN QUILT 3.032 trial indicate stability of physical function

ImmunityBio announced that findings from Patient-Reported Outcomes PROs of participants in the phase 2/3 QUILT 3.032 study of N-803 plus BCG in BCG-unresponsive non-muscle invasive bladder cancer NMIBC were published by the peer-reviewed journal Urology Practice. These PROs support the positive interim results from the study published in NEJM Evidence, wherein 71% of patients in cohort A with CIS with or without Ta/T1 disease achieved a complete response. The published PROs based on a May 16 data cutoff indicate that both physical function and global health as self-reported by QUILT 3.032 participants with BCG-unresponsive NMIBC CIS or papillary disease remained stable over the 2-year course of the study for patients who completed the PRO questionnaires and reached 24 months on-study. The primary end point is the incidence of CR at the 3- or 6-month assessment visit for cohorts A and C, and the disease-free survival DFS rate at 12 months for cohort B. …The FDA has accepted for review ImmunityBio’s resubmission of its biologics license application (BLA) for N-803 plus BCG for the treatment of BCG-unresponsive NMIBC CIS with or without Ta or T1 disease, and has set a user fee goal date PDUFA date of April 23.