- QUILT 3.032 study completes planned enrollment of BCG unresponsive non-muscle invasive bladder cancer CIS cohort with a 59% probability of patients maintaining complete response for at least 12 months
- Over 85% of patients in this study have avoided a cystectomy to date
- Breakthrough status for ImmunityBio’s superagonist Anktiva N-803 in this indication
- Biologics License Application filing anticipated in the second half of 2021
San Francisco, CA (UroToday.com) — ImmunityBio, Inc., a privately-held immunotherapy company, announced positive data from the first cohort of a pivotal Phase 2/3 trial (QUILT 3.032) for non-muscle invasive bladder cancer in high risk carcinoma in situ (CIS) disease. The data showed 51 out of 71 evaluable patients (72%) had a complete response (at any time) to intravesical BCG plus N-803 (Anktiva), with 59% probability of these patients maintaining a complete response for at least 12 months, with a median duration of complete response of 19.2 months to date.