ImmunityBio Inc. (NASDAQ: IBRX) stock declined by 4.2% at last close whereas the IBRX stock-price gains by 9.75% in the after-hour trading session. ImmunityBio is a prominent late-stage immunotherapy business focused on creating next-generation medicines that stimulate immunogenic processes in cancer and infectious disease treatment.
IBRX stock’ Recent Past Development
ImmunityBio has released new results from a bladder cancer trial that shows individuals with BCG-unresponsive non-muscle invasive carcinoma in situ (CIS) bladder cancer had maintained full responses (Cohort A). In the QUILT 3.032 trial, 58 patients (72%) had a full response (CR) to intravesical BCG plus N-803 (Anktiva) at any period (three or six months), with a median CR period of 19.9 months.
Based on Kaplan-Meier assessment, responding patients had a 59 percent chance (95 percent confidence interval: 43.1 percent, 71.2 percent) of maintaining a full response for more than 12 months. The CR rate was 77% for patients who had a CR during the first three months, with a 61 percent chance of remaining disease free after 18 months, despite the fact that the median length of complete response had not yet been achieved in that group. With a median follow-up of 20.4 months, 85 percent of patients in the group avoided a cystectomy.
Principal Investigator Karim Chamie, Associate Professor of Urology at UCLA commented,
According to the statistics, a significant majority of patients who react completely to therapy within the first three months will sustain that response for at least 18 months, if not longer. Most notably, 85 percent of the individuals in the cohort were spared from having their cysts removed. The AUA-FDA workshop established a high, clinically relevant bar: 30 percent of patients with BCG-unresponsive bladder cancer who received therapy remained disease-free for 18–24 months. Unfortunately, none of the FDA-approved (or under FDA assessment) drugs have come close to meeting the aim, just 20% of patients remain disease-free after 12 months.
However, they now have a product with N-803 + BCG that has met the AUA-FDA 30 percent 18-month goal for the very first time. He is convinced that N-803 + BCG will have an influence on the lives of individuals with BCG-unresponsive bladder cancer due to its well-tolerated safety profile.
