ImmunityBio Inc (NASDAQ:IBRX) announced data from its bladder cancer trial (QUILT-3.032) Phase 2/3 study of intravesical BCG plus Anktiva (N-803).
- The data showed sustained complete response rates in patients with BCG-unresponsive non-muscle-invasive carcinoma in situ (NMIBC CIS) bladder cancer (Cohort A), and papillary disease (Cohort B).
- Of the 83 patients with BCG-unresponsive NMIBC CIS, 59 (71%) had a complete response with a median duration of response of 24.1 months.
- The rates exceeded historical complete response rates of 41% and 18% for FDA-approved Merck Co & Inc's (NYSE:MRK) Keytruda (pembrolizumab) and Endo International Plc's (NASDAQ:ENDP) Valstar (valrubicin), respectively.
- Also See: ImmunityBio's Shares Jump On Encouraging Data From Pancreatic Cancer Immunotherapy Trial.
- In the papillary disease arm of the study (Cohort B), 57% of patients are disease-free at 12 months and 53% at 18 months.
- In Cohort A, 24.1 months median durable complete remission was seen, with 96% and 91% avoidance of bladder cancer progression and cystectomy, respectively, at 24 months in responders.
- 100% bladder cancer-specific overall survival was observed at 24 months.
- In Cohort B, 99% overall bladder cancer-specific survival and 95% Cystectomy avoidance rate were seen.
- Price Action: IBRX shares are up 17.7% at $6.77 during the market session on the last check Tuesday.
