KEY TAKEAWAYS
- The QUILT 3.032 Phase 2/3 study assessed QoL of patients with BCG-unresponsive NMIBC receiving IL-15RαFc superagonist N-803 plus BCG.
- Quality of life (QOL) was measured using the EORTC QOL Questionnaire Core 30 (QLQ-C30) and QOL NIMBC-Specific 24 Questionnaire (QLQ-NMIBC24) in Cohort A.
- Cohort A had a CR rate of 71% (median duration 26.6 months), 89.2% cystectomy avoidance, and 100% bladder cancer specific survival at 24 months with NAI plus BCG treatment.
- QOL measurement supports good tolerability of the intravesical NAI plus BCG in BCG-unresponsive, high-grade NMIBC patients with CIS. Mild worsening vs. baseline in feeling ill was reported by a small percentage of patients, and physical function scores were stable or slightly improved compared to baseline.
Treatment options are restricted for patients (pts) with BCG-unresponsive NMIBC, and they are at a higher risk of having to have a cystectomy. In this patient population, BCG and the interleukin-15 superagonist nogapendekin alfa inbakicept (NAI, or N-803) work together to produce innate immune memory and, ultimately, persistent complete responses (CRs). Patients with carcinoma in situ (CIS; Cohort A) have a CR rate of 71% (median duration 26.6 months), 89.2% cystectomy avoidance, and 100% bladder cancer specific survival at 24 months 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; NCT03022825). Now, for the first time, we present quality of life (QOL) statistics from the same patients group.
About 86 patients (median age 73; 87% male) with histologically proven CIS with or without Ta/T1 illness were treated with intravesical BCG 50 mg with NAI 400 g (cohort A). 82% of patients had a score of 0 or 1 on the ECOG at baseline. The quality of life was assessed using the EORTC Quality of Life Questionnaire Core 30 (QLQ-C30) and the Quality of Life Questionnaire for Patients with NIMBC (QLQ-P24) (QLQ-NMIBC24). No substantial shifts in quality of life (QOL) dimensions have occurred over time, according to multivariate analyses. After weeks 27 and 52, 6% and 3% of pts reported mild worsening compared to baseline in feeling ill, while 4% and 6%, respectively, reported improvement. Seven percent of patients (pts) and 9 percent of pts (pts) at weeks 78 and 104, respectively, indicated improvement in their wellbeing compared to baseline, with the remainder reporting stability (non-significant).
In terms of physical function (PF) score, no statistically significant differences were found (baseline vs. week 27, 52, 78 and 104). Patients who responded to therapy had higher PF scores than those who did not; however, the baseline value of PF was also greater in the therapy responders than in the non-responders. Scores on measures of physical function were numerically higher by week 27 compared to baseline than they had been in previous studies with BCG alone; these scores then declined to a low point by week 78 before rising again by week 104. (non-significant). Throughout the research, the percentage of patients hospitalised for any reason stayed low (between 0% and 6% throughout evaluations).
Quality of life measurements corroborate the safety of intravesical NAI with BCG for BCG-unresponsive, high-grade NMIBC patients with CIS. This study adds to the growing body of evidence supporting the innovative combination immunotherapy’s superior benefit-to-risk profile in the treatment of a difficult disease.
Source: https://meetings.asco.org/abstracts-presentations/216729
Clinical trial: https://clinicaltrials.gov/ct2/show/NCT03022825/
Karim Chamie, Sam S. Chang, Eugene V. Kramolowsky, Mark L. Gonzalgo, Stanislav Lechpammer, Sandeep K. Reddy, Patrick Soon-Shiong, J Clin Oncol 41, 2023 (suppl 6; abstr 495), DOI: 10.1200/JCO.2023.41.6_suppl.495
