In the phase 2/3 study QUILT 3.032 (NCT03022825), the ability of the IL-15RαFc superagonist N-803 (nogapendekin alfa inbakicept or NAI) plus bacillus Calmette-Guerin (BCG) to elicit durable complete responses (CRs) in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) was demonstrated. As a secondary endpoint, patient-reported outcomes (PROs) were assessed.
Both cohort A patients with carcinoma in situ with or without Ta/T1 disease and cohort B patients with high-grade Ta/T1 papillary disease who received N-803 plus BCG therapy completed EORTC Core 30 and QoL NMIBC-Specific 24 questionnaires at baseline and months 6, 12, 18 and 24 on-study. Scores were analyzed using descriptive statistics and multivariable analyses were performed to identify baseline variables associated with PROs.
On-study, mean physical function (PF) and global health (GH) scores remained relatively stable from baseline for cohorts A (n = 86) and B (n = 78). At month 6, cohort A patients with a CR reported higher PF scores than those without (P = 0.0659); at month 12, > 3 as compared with ≤ 3 prior TURBT was associated (P = 0.0729) with lower GH scores. In cohort B, baseline disease type was associated (P = .0738) with PF and race was significantly associated (P = 0.0478) with GH at month 6. NMIBC-Specific 24 summary scores also remained stable on study for both cohorts.
The overall stability of PROs scores taken together with the efficacy findings, indicate a favorable risk/benefit ratio and quality of life following N-803 plus BCG.
Urology practice. 2024 Jan 16 [Epub ahead of print]
Karim Chamie, Sam S Chang, Eugene V Kramolowsky, Mark L Gonzalgo, Megan Huang, Paul Bhar, Patricia Spilman, Lennie Sender, Sandeep K Reddy, Patrick Soon-Shiong
Department of Urology, UCLA Medical Center, Los Angeles, California., Department of Urology, Vanderbilt Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, Tennessee., Virginia Urology, Richmond, Virginia., Desai Sethi Urology Institute, University of Miami Miller School of Medicine, Miami, Florida., ImmunityBio, Inc., Culver City, California.