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

ImmunityBio Inc 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 MRK Keytruda (pembrolizumab) and Endo International Plc's 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.