N-803 Plus BCG Shows Promising Physical Function Improvement in BCG-Unresponsive Bladder Cancer Patients

A recent study published in the peer-reviewed journal Urology Practice has highlighted the potential benefits of a new immunotherapy combination for bladder cancer patients who do not respond to Bacillus Calmette-Guerin (BCG) treatment. The phase 2/3 QUILT 3.032 trial, conducted by ImmunityBio, Inc., investigated the interleukin-15 superagonist N-803 in conjunction with BCG for treating non-muscle invasive bladder cancer (NMIBC). The trial's findings, based on data as of May 16, 2022, demonstrate that patients who completed the study's Patient-Reported Outcomes (PROs) questionnaires and were on the study for 24 months maintained stable physical function and global health.
Notably, patients who achieved a complete response (CR) to the N-803 and BCG combination therapy reported improved physical function by the sixth month of the study, compared to those who did not achieve a CR. The study's Executive Chairman, Patrick Soon-Shiong, M.D., emphasized that the self-reported stability of health and physical function is indicative of the safety and tolerability of the new therapy. The positive response rate of over 70% in cohort A, along with the durability of responses and avoidance of cystectomy, suggests a favorable risk-benefit profile for N-803 plus BCG.
The QUILT 3.032 study, which is still ongoing, includes three cohorts of patients, with A and B receiving the N-803 and BCG combination, and C receiving N-803 monotherapy. The primary endpoint of the study is the incidence of CR at 3 or 6 months for cohorts A and C, and disease-free survival at 12 months for cohort B. Secondary endpoints include durability of response, avoidance of cystectomy, and overall survival.
The FDA is currently reviewing the Biologics License Application (BLA) for N-803 plus BCG, with a Prescription Drug User Fee Act (PDUFA) date set for April 23, 2024. If approved, this combination therapy could offer a new treatment option for patients with NMIBC who do not respond to BCG, potentially avoiding the need for more invasive procedures like radical cystectomy.
ImmunityBio, a clinical-stage biotechnology company, is focused on developing next-generation therapies and vaccines to enhance the immune system's ability to combat diseases such as cancer and infectious diseases. Their immunotherapy and cell therapy platforms aim to provide more effective, accessible, and easily administered treatments compared to current standards of care.