Abstract 68P
Background
This open-label, multi-center phase II study (NCT04849416) demonstrated the efficacy and safety of pirtobrutinib, a non-covalent (reversible) BTK inhibitor, in Chinese patients with relapsed/refractory (R/R) B-cell malignancies, including MCL, and post-cBTKi treatment (Song et al. ASH 2023). This analysis reports the first PROs from Chinese patients with R/R MCL receiving pirtobrutinib.
Methods
PROs were assessed at Day 1 of each cycle (C) and at the end of treatment. Health-related quality of life (HRQoL) was measured using the EORTC QLQ-C30 physical functioning (PF) and global health status/quality of life (GHS/QoL) subscales (higher scores denote better outcomes). MCL symptoms and fatigue were assessed using 13 and 6 items, respectively, selected from EORTC Item Library and QLQ-C30 (higher scores denote worse symptoms). All subscales are scored 0–100. Changes from baseline (BL, i.e. C1) were categorized as improved, worsening, or stable, by the minimum clinically important difference (MCID) thresholds from the phase II BRUIN study (NCT03740529). Mean subscale scores and patient proportions in each category were summarized per cycle and presented up to C12.
Results
35 patients with post-cBTKi MCL were included (mean age, 65.1 [Standard Deviation (SD), 7.1] years; 65.7% male). Questionnaire completion was 97.1% for the 35 patients expected at BL and 100% for the 11 patients expected at C12. Mean GHS/QoL scores rose by 17.6 (above the MCID of 16.7; BL, 67.2 [SD, 18.8]; C12, 84.8 [SD, 18.9]). Mean PF scores were 90.0 [SD, 10.2] at BL and increased to 93.3 [SD, 7.3] at C12. Mean MCL symptom and fatigue scores decreased from 9.2 [SD, 7.7] and 12.6 [SD, 11.1] at BL to 8.2 [SD, 7.9] and 11.1 [SD, 12.4] at C12, respectively. The majority of patients reported stable or improved outcomes from BL at each subsequent cycle through C12 for GHS/QoL (≥90.9%), PF (≥72.7%), MCL symptom (≥82.4%) and fatigue (≥70.6%).
Conclusions
PROs were maintained or improved through C12 for the majority of Chinese patients with R/R MCL post-cBTKi in this study. Results should be interpreted with caution due to the single arm design and small numbers of patients.
Clinical trial identification
NCT04849416.
Editorial acknowledgement
Medical writing support was provided by Gavin Phillips, BSc at Rude Health Consulting, and was funded by Eli Lilly China.
Legal entity responsible for the study
The authors.
Funding
Eli Lilly China.
Disclosure
Y. Qian, J. Zhu, Y. Ding: Financial Interests, Personal, Full or part-time Employment: Eli Lilly. All other authors have declared no conflicts of interest.