- Results confirm prolonged sustained complete response, with 71% of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS) having a complete remission with a median duration of response of 24.1 months
- By contrast, historical complete response rates for FDA-approved therapies pembrolizumab and valrubicin are of 41% and 18%, respectively1 & 2
- In addition, for patients with papillary disease, a disease-free survival rate at 18 months of 53%, which more than doubles the 25% rate published by the International Bladder Cancer Group as clinically meaningful
- A cystectomy avoidance rate of over 90% (91% of CIS patients and 95% of papillary patients)
- A 96% avoidance rate of progression to muscle invasive bladder cancer for CIS patients who responded to therapy
- Zero treatment-related or immune-related adverse events or grade 4/5 adverse events
Reno, Nevada (UroToday.com) — ImmunityBio, Inc., a clinical-stage immunotherapy company, announced positive data from the company’s late-stage bladder cancer trial (QUILT-3.032). 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 with 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—exceeding historical complete response rates of 41% and 18% for FDA-approved therapies pembrolizumab and 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.