ImmunityBio Completes ANKTIVA's Post-Approval Enrollment Of The 100th Patient In BCG Unresponsive NMIBC CIS Trial And Reports A Complete Response Rate Of 71% With A Durable Duration Of Response Ranging Up To 54 Months Reported For 82 Patients Published In NEJM
- High responder rate associated with a duration of response ranging as long as 54 months in QUILT-3.032 with 100 patients enrolled
- Updated data intended to be submitted as part of a European Medicines Agency (EMA) Submission in Q4 2024
- Complete response data in 100 patients consistent with CR rate of 71% reported for 82 patients published in NEJM
ImmunityBio, Inc. ((IBRX), a leading immunotherapy company, today announced compelling new data from its ongoing QUILT 3.032 study. As of November 2024, 100 patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (NMIBC CIS) have been treated with ANKTIVA (nogapendekin alfa inbakicept-pmln) in combination with BCG, achieving a 71% complete response (CR) rate. In these responders, the range of durable response extended to 54 months. This data update will be submitted to the European Medicines Agency (EMA) in a Marketing Authorization Application (MAA) for ANKTIVA in the European Union (EU), which is anticipated during Q4 2024.
This significant milestone underscores the potential of ANKTIVA to provide durable responses in patients with limited treatment options. The QUILT 3.032 study is a single-arm, multicenter trial evaluating the safety and efficacy of ANKTIVA plus BCG in patients with BCG-unresponsive NMIBC CIS. The observed 71% CR rate aligns with previous findings reported in the New England Journal of Medicine (NEJM Evidence, Chamie 2022) and reinforces the therapeutic promise of this combination therapy.
