ImmunityBio reports positive results in bladder cancer

Immunotherapy company ImmunityBio’s (Nasdaq: IBRX) shares were up more than 10% at $6.33 pre-market today, after late Monday it 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 Food and Drug Administration (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.

“We are excited with these promising results,” said Dr Sam Chang, urologic surgery chief surgical officer, Vanderbilt Ingram Cancer Center and trial investigator. “This study suggests that BCG induces trained immunity as the prime, while N-803 serves as a vital boost for innate immune memory. These results of high efficacy activity and excellent safety profile set a new bar for NMIBC treatment, and together with the familiar and favorable mode of administration, will advance our current standards of care for patients with bladder cancer,” he noted.