Patient-Reported Outcomes (PRO) in Patients with Stage 2/3 Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) Carcinoma in Situ (CIS; Cohort A) or Papillary Disease (Cohort B) N-803 Plus BCG’s QUILT 3.032 study (NCT03022825) completed the PRO questionnaire and reached study month 24, showing stability in physical function and overall health over the course of 2 years.1
Published PROs as of the data cutoff date of May 16, 2022, show that overall, patients in Cohorts A and B were also reported no decrease in their health status or urinary tract-related symptoms during the study period. By 6 months, patients who achieved complete remission (CR) with the combination of BCG and N-803 also had better physical function than those who did not achieve CR.
These results from the PRO analysis support positive interim results from the Phase 2/3 QUILT 3.032 study, which was previously published in New England Journal of Medicine Records. Additionally, these data support the safety and tolerability of this combination as a potential new treatment option for patients with BCG-nonresponsive bladder cancer.
“The stability of participants’ self-reported health and physical function over the course of the study reflects another aspect of the safety and tolerability of this new combination therapy,” said Patrick Soon-Shiong, MD, executive chairman and global chief scientific officer. explain. ImmunityBio officials said in a press release. “Combined with the greater than 70% positive response rate, sustained response, and avoidance of cystectomy in Cohort A, these quality-of-life findings suggest that this potential new treatment option has a favorable risk-benefit ratio for patients with BCG-unresponsive bladder cancer. .”
Previous results from the phase 2/3 study showed that 71% of patients with Group A CIS with or without Ta/T1 disease achieved CR, with a median duration of response of 26.6 months. 2 The avoidance rate of cystectomy is 89.2%, and the 24-month overall survival rate of bladder cancer is 100%.
The combination also produced a favorable safety profile with no serious adverse events reported, supporting the favorable risk-benefit ratio of N-803 plus BCG in this patient population.1
QUILT 3.032 is an open-label, single-arm, multicenter, phase 2/3 trial enrolling patients with persistent or recurrent CIS within 12 months of adequate treatment with BCG (cohort A) or papillary recurrent high-grade CIS Within 6 months of completion of adequate BCG therapy for Ta-T1 disease. Patients received 50 mg BCG plus 400 μg intravesical N-803 weekly for 6 weeks or reinduction therapy for 6 weeks and maintained for up to 3 years.2
The primary endpoint in Arm A was biopsy-confirmed CR at 3 or 6 months. In cohort B, the primary endpoint was disease-free rate at 12 months. Secondary endpoints of the study included duration of CR, avoidance of cystectomy, time to cystectomy, and safety.
A Biological products license application for N-803 plus BCG Drugs for the treatment of NMIBC CIS have been submitted and are currently under FDA review. The Prescription Drug User Fee Act is set for April 23, 2024.
ImmunityBio’s quality-of-life study in the BCG-unresponsive bladder cancer trial showed that 71% of complete responders experienced improved physical function, suggesting that N-803 plus BCG has a favorable risk-benefit ratio. Press Releases. ImmunityBio, Inc. February 5, 2024. Accessed February 6, 2024. http://tinyurl.com/4z7bkact
Chamie K, Chang S, Gonzalgo M, et al. Final clinical results from a pivotal trial of the FFIL-15RαFc superagonist N-803 in combination with BCG for the treatment of BCG-nonresponsive CIS and papillary non-muscle-invasive bladder cancer (NMIBC). Presented at: 2022 American Society of Clinical Oncology Annual Meeting; June 2-6, 2022; Virtual. Abstract 4508.