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Tuesday, February 15, 2022

ImmunityBio's Ankitva Shows 100% Survival At Two Years In Bladder Cancer

 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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