ImmunityBio Inc
(Get Free Alerts for 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 (Get Free Alerts for MRK) Keytruda (pembrolizumab) and Endo International Plc's Valstar (valrubicin), respectively.
- 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.
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