N-803 Plus BCG Shows Favorable Outcomes in BCG-Unresponsive Bladder Cancer Patients

The QUILT 3.032 trial has revealed that the interleukin-15 (IL-15) superagonist N-803, when combined with bacillus Calmette-Guerin (BCG), shows promising results in maintaining physical function and overall health in patients with non-muscle invasive bladder cancer (NMIBC). The study, which was published in the peer-reviewed journal Urology Practice, assessed the effects of this new treatment on patients who had not responded to previous BCG therapy.

Data collected up to May 16, 2022, demonstrated that patients who completed the 24-month study and filled out the Patient-Reported Outcomes (PROs) questionnaires exhibited stability in their physical function and global health. Notably, those who achieved a complete response (CR) to the combination therapy at the six-month mark reported improved physical function compared to those who did not achieve a CR.

The findings suggest that the novel combination of N-803 and BCG is as safe and tolerable as BCG monotherapy, which is the current standard of care for intermediate and high-risk NMIBC patients. The study's results, including a 71% complete response rate and an 89.2% cystectomy avoidance rate in cohort A, along with the favorable safety profile, indicate a positive risk-benefit ratio for the new treatment option.

ImmunityBio, the company behind the development of N-803, is currently awaiting the Food and Drug Administration's (FDA) decision on the Biologics License Application (BLA) for N-803 plus BCG. The Prescription Drug User Fee Act (PDUFA) date for the treatment of NMIBC CIS is set for April 23, 2024.

The QUILT 3.032 study is an ongoing phase 2/3 multicenter trial that includes three cohorts of patients with BCG-unresponsive NMIBC. Cohorts A and B received the combination therapy, while cohort C, which received N-803 monotherapy, was discontinued due to a low response rate. The primary endpoint of the study is the incidence of CR at the 3- or 6-month assessment visit for cohorts A and C, and the disease-free survival rate at 12 months for cohort B.

Bladder cancer is the tenth most commonly diagnosed cancer, with NMIBC accounting for approximately 80% of new cases. BCG instillation is the standard treatment for intermediate and high-risk NMIBC patients, yet a significant number fail BCG therapy or relapse after an initial response, leading to a diagnosis of BCG-unresponsiveness. The QUILT 3.032 study aims to provide a safe and effective alternative for these patients, potentially reducing the need for radical cystectomy.

ImmunityBio is a clinical-stage biotechnology company focused on developing next-generation therapies and vaccines to enhance the immune system's ability to combat cancers and infectious diseases. The company's immunotherapy and cell therapy platforms are designed to be more effective and accessible than current standards of care, with the goal of creating durable and safe protection against disease.

The FDA has accepted ImmunityBio's resubmission of its BLA for N-803 plus BCG for the treatment of BCG-unresponsive NMIBC CIS, setting a PDUFA date of April 23, 2024. The company is hopeful that the new treatment will offer a favorable alternative for patients with BCG-unresponsive bladder cancer, potentially improving their quality of life and reducing the need for more invasive procedures.