Zanubrutinib versus ibrutinib in relapsed/refractory chronic lymphocytic leukemia and small lymphocytic lymphoma (R/R CLL/SLL): Impact on health‐related quality of life

Introduction: Zanubrutinib (zanu) is a potent and highly selective next-generation Bruton tyrosine kinase (BTK) inhibitor designed to maximize BTK occupancy minimize off-target effects. In the ALPINE study (NCT03734016), zanu demonstrated superiority ibrutinib (ibr) in both progression-free survival (PFS) overall response rate more favorable safety profile R/R CLL/SLL. The purpose of this analysis was assess health-related quality life (HRQOL) patients (pts) treated with ibr. Results from data cutoff related recent PFS (8 Aug 2022) are reported here. Methods: HRQOL measured by EORTC QLQ-C30 EQ-5D-5L at baseline, cycle 1, every 3rd 28-day until end treatment. Key pt-reported outcome (PRO) endpoints included global health status (GHS), physical role functions, fatigue, pain, diarrhea, nausea/vomiting. Descriptive conducted on all scales; mixed-model repeated-measure using key PRO clinical cycles 7 (6 months) 13 (12 performed. Adjusted completion rates were defined as number pts who completed questionnaires each divided still Clinically meaningful ≥5% mean change difference baseline. Results: A total 652 randomized receive (n = 327) or ibr 325); baseline characteristics generally similar between arms, although arm had fewer males versus (65.1% vs. 71.4%). At GHS, functional, symptom scales scores arms. Although ibr-treated discontinued treatment due adverse events (22.2% 15.4%), adjusted high (89.6% 94.3%) (87.7% 92.3%), respectively. By 7, GHS improved 13, no longer significant (Table). Pts experienced clinically improvements functioning well pain fatigue but arms not significant. lower diarrhea scores, treatments Nausea/vomiting maintained measurable difference. VAS showed greater improvement (7.92 3.44) (7.75 3.92) ibr, Conclusions: ALPINE, CLL/SLL GHS/QoL scale 7. Other continued improve, suggesting positively affected over time. As expected, given good differences small Encore Abstract - previously submitted EHA 2023 research funded by: BeiGene Keyword: Chronic Lymphocytic Leukemia (CLL) Conflicts interests pertinent abstract. B. Eichhorst Consultant advisory role: Janssen, AbbVie, Gilead, AstraZeneca, BeiGene, MSD, Lilly Honoraria: Roche, MSD Research funding: AstraZeneca Educational grants: N. Lamanna Abbvie, Eli Lily/Loxo, Genentech, Pharmacyclics Octapharma, Oncternal, MingSight, TG Therapeutics S. M. O'Brien Alexion, Amgen, Aptose Biosciences Inc., Astellas, Autolus, BMS, Celgene, DynaMed, Company, GSK, Janssen Oncology, Johnson Johnson, Juno Therapeutics, MEI Pharma Merck, NOVA Pfizer, Pharmacyclics, Vaniam Group Verastem, Vida Ventures Nurix Mustang, Loxo Oncology Kite, Caribou Biosciences, Inc. Ltd., Alliance, Acerta C. Tam AbbVie remuneration: L. Qiu Astra Zeneca, Takeda, Beigene K. Yang Employment leadership position: Stock ownership: Wu (Self), Roche/Genentech (Spouse) T. Salmi G. Barnes J. R. Brown iOnctura, Loxo/Lilly, Pharma, SecuraBio, Sun,