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UPJ INSIGHT Quality of Life in the Phase 2/3 Trial of N-803 Plus Bacillus Calmette-Guérin

By: Karim Chamie, MD, University of California, Los Angeles Medical Center; Sam S. Chang, MD, Vanderbilt Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, Tennessee; Eugene V. Kramolowsky, MD, Virginia Urology, Richmond; Mark L. Gonzalgo, MD, Desai Sethi Urology Institute, University of Miami Miller School of Medicine, Florida; Megan Huang, PhD, ImmunityBio, Inc, Culver City, California; Paul Bhar, MS, ImmunityBio, Inc, Culver City, California; Patricia Spilman, MA, ImmunityBio, Inc, Culver City, California; Lennie Sender, MD, ImmunityBio, Inc, Culver City, California; Sandeep K. Reddy, MD, ImmunityBio, Inc, Culver City, California; Patrick Soon-Shiong, MD, ImmunityBio, Inc, Culver City, California | Posted on: 18 Mar 2024

Chamie K, Chang SS, Kramolowsky EV, et al. Quality of life in the phase 2/3 trial of N-803 plus bacillus Calmette-Guérin in bacillus Calmette-Guérin–unresponsive nonmuscle-invasive bladder cancer. Urol Pract. 2024;11(2):367-375.

Study Need and Importance

To address the need for safe, efficacious, standard of care therapy for bacillus Calmette-Guérin (BCG)–unresponsive nonmuscle-invasive bladder cancer (NMIBC), the phase 2/3 study QUILT-3.032 was conducted to assess the ability of the investigational IL-15RαFc superagonist N-803 plus BCG to elicit complete responses (CRs) in this patient population. We previously reported a CR rate of 71% in cohort A patients with carcinoma in situ with or without Ta/T1 disease, with a median duration of 26.6 months and a disease-free survival rate of 55.4% at 12 months for cohort B patients with high-grade Ta/T1 papillary NMIBC.

What We Found

Here, we describe patient-reported outcomes based on EORTC (European Organization for Research and Treatment of Cancer) Core 30 and Quality of Life (QoL) NMIBC-Specific 24 questionnaires, revealing the stability of participant QoL on study, including both global health (GH) and physical function summary scores from the EORTC Core 30. Not unexpectedly, patients who achieved a CR maintained higher GH and physical function summary scores, and a greater number (> 3) of transurethral resections of bladder tumor was associated with lower GH scores as compared with ≤ 3 transurethral resections of bladder tumor (Figure). Answers to the NMIBC-specific questions in the QoL NMIBC-Specific 24 questionnaire suggest a difference in concerns in patients with less advanced disease in cohort A, who reported changes in sexual function and activity, as compared to those with the more progressed high-grade papillary disease in cohort B, who appeared to focus more on future worries and intravesical treatment issues.

Figure. Global health (GH) and physical function (PF) summary scores. GH (A) and PF (B) 390 summary scores for all participants in cohorts A and B. N numbers at each time point are color-coded. Data are graphed as mean and SD. BCG indicates bacillus Calmette-Guérin; EORTC, European Organization for Research and Treatment of Cancer.


The single-arm design of QUILT-3.032, used based on the known futility of BCG monotherapy in BCG-unresponsive patients, might be considered a limitation.

Interpretation for Patient Care

The favorable risk-benefit ratio for this novel combination therapy, including a CR rate in cohort A that is higher than those for other currently Food and Drug Administration–approved therapies for this indication and reasonable safety, suggests intravesical N-803 plus BCG has potential to provide an efficacious therapeutic option for BCG-unresponsive NMIBC patients.