ASCO GU 2023: Quality of Life in QUILT 3.032 Study: Patients with BCG-Unresponsive NMIBC Receiving IL-15RαFc Superagonist N-803 plus BCG

( The 2023 GU ASCO annual meeting included a session on urothelial carcinoma, featuring a presentation by Dr. Karim Chamie discussing quality of life in the QUILT 3.032 study, specifically patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) receiving IL-15RαFc superagonist N-803 plus BCG. Patients with BCG-unresponsive NMIBC have limited treatment options and are at an increased risk for cystectomy. Nogapendekin alfa inbakicept (NAI, also known as N-803), is an interleukin-15 superagonist (IL-15RαFc), which synergizes with BCG to elicit innate immune memory resulting in durable complete responses in this patient population. In an open-label, 3-cohort, multicenter Phase 2/3 study of intravesical BCG plus NAI in BCG-unresponsive high-grade NMIBC (QUILT 3.032;1 NCT03022825), patients with carcinoma in situ (CIS; Cohort A) have a complete response rate of 71% (median duration 26.6 months), 89.2% cystectomy avoidance and 100% bladder cancer specific survival at 24 months. At the 2023 GU ASCO annual meeting, Dr. Chamie and colleagues presented results of the first quality of life data report in the same patient cohort.

Cohort A included 86 patients (median age 73 years; 87% male) with histologically confirmed BCG-unresponsive CIS with or without Ta/T1 disease, treated with intravesical BCG 50 mg plus NAI 400 μg. The mean baseline ECOG score was 0.183, with 82% of patients having a score of 0. Quality of life was measured by the EORTC QOL Questionnaire Core 30 (QLQ-C30) and QOL NIMBC-Specific 24 Questionnaire (QLQ-NMIBC24).

Hospitalizations for any reason remained low (0% - 6% per assessments) during the study. Participant quality of life form completion rate was high, being 90% or greater at most time points. There was a modest decrease in mean physical function and global health from baseline at all assess on-study time points that became less by week 104:

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When responders (those with a complete response) were compared with non-responders, they showed less of a decrease in physical function and global health scores with time, although both parameters were higher at baseline for responders:

ASCO GU QUILT 3.032.jpg

At month 12, >3 prior TURBTs was significantly associated (p = 0.0729) with lower global health scores as compared to <= prior TURBTs. At month 6, achievement of a complete response was significantly associated (p = 0.0659) with higher physical function scores as compared to no complete response. No other baseline variable had significant level of association:

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Dr. Chamie concluded his presentation discussing quality of life in the QUILT 3.032 study for patients with BCG-unresponsive NMIBC receiving IL-15RαFc superagonist N-803 plus BCG with the following take-home messages:

  • The modest decrease in global health and physical function scores over time that became less by 2 years (104 weeks) is similar to that reported for BCG alone
  • A higher number of prior TURBTs may indicate a relatively poorer condition of the bladder that results in lower global health cores
  • The higher physical function scores for responders is not unexpected and may be a result of resolved disease
  • The relative stability of physical function and global health, when considered with the high rate of cystectomy avoidance, further strengthens the evidence of a favorable risk-benefit ratio for the novel BCG + N-803 immunotherapy for BCG-unresponsive NMIBC 

Presented by: Karim Chamie, MD, UCLA Department of Urology, Los Angeles, CA

Co-Authors: Sam S. Chang, Eugene V. Kramolowsky, Mark L. Gonzalgo, Stanislav Lechpammer, Sandeep K. Reddy, Patrick Soon-Shiong

Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Assistant Professor of Urology, Georgia Cancer Center, Augusta University/Medical College of Georgia, @zklaassen_md on Twitter during the 2023 Genitourinary (GU) American Society of Clinical Oncology (ASCO) Annual Meeting, San Francisco, Thurs, Feb 16 – Sat, Feb 18, 2023. 


  1. Chamie K, Chang SS, Kramolowsky E, et al. IL-15 Superagonist NAI in BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer. NEJM Evid 2022; 2(1)