Health‐related quality of life in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma treated with liso‐cel in TRANSCEND CLL 004

Introduction: Patients (pt) with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphoma (SLL), especially those progression on Bruton tyrosine kinase inhibitors (BTKi) and venetoclax failure, have limited treatment options poor pt-reported outcomes (PRO)/health-related quality of life (HRQOL). The CD19-directed chimeric antigen receptor T cell therapy lisocabtagene maraleucel (liso-cel) is being evaluated in R/R CLL/SLL the phase 1/2 TRANSCEND CLL 004 study (NCT03331198). Here, we report PRO/ HRQOL for pts 2 part 004. Methods: Pts completed European Organisation Research Treatment Cancer Quality Life Questionnaire (EORTC QLQ)-30 items (C30), EORTC QLQ-17 (CLL17), EQ-5D-5L at baseline (≤7 days before lymphodepletion), preinfusion day liso-cel infusion (Day 1), 30, 60, 90, 180, 270, 365, 455, 545, 730 after infusion. primary domains interest were QLQ-C30 global health status (GHS)/quality (QOL), physical functioning, role cognitive fatigue QLQ-CLL17 symptom burden condition/fatigue. PRO-evaluable population was defined as ≥1 postbaseline PRO assessment, among all leukapheresed portion. Observed scores mean changes from calculated across visits. Intra-pt meaningful using prespecified change thresholds. Results: Of 112 70 BTKi progressed/venetoclax failure subset, completion rates 61% both populations, 40%–70% most visits measures. main reasons not completing PROs COVID-19–related restrictions. Outcomes similar populations. Mean worse than United States general many domains. After initial deterioration infusion, observed showed improvement starting Day 60 (representative shown Figure) except functioning score, which comparable maintained over time. proportion increased time multiple domains, including fatigue-related GHS/QOL QLQ-CLL17. From 90 through 730, proportions no exceeded deterioration. research funded by: This by Juno Therapeutics, a Bristol-Myers Squibb Company. All authors contributed to approved abstract; writing editorial assistance provided Stephen Gilliver, PhD, Evidera (Bethesda, MD, USA), Bu Reinen, CMPP, Lockwood Group (Stamford, CT, Bristol Myers Squibb. Keyword: Cellular therapies Conflicts interests pertinent abstract. D. G. Maloney Consultant advisory role: A2 Biotherapeutics, Member Scientific Advisory Board, Navan Technologies, Chimeric Genentech, Chair Lymphoma Steering Committee, BMS, JCAR017 EAP-001 Safety Review Member, Strategic Council, ImmPACT Bio, Clinical CD19/CD20 bi-specific CAR-T Cell Therapy Program, Gilead Sciences, Scholars Program Hematologic Malignancies, Interius. JCAR017-BCM-03 Committee Stock ownership: Technologies Honoraria: Caribou Biosciences, Inc., Celgene, Incyte, Kite, Lilly, Mustang Novartis, Umoja funding: Kite Pharma, Legend Biotech, BMS Other remuneration: Rights royalties Fred Hutch patents licensed Therapeutics/BMS T. Siddiqi Astra Zeneca, pharma, Beigene, Abbvie Oncternal, Ascentage TG therapeutics, Pharmacyclics, therapeutics Speaker's Bureau: Beigene B. Fakhri Abbvie, Astrazeneca, Adaptive, pharmacyclics, CSL Behring, LOXO-Lilly Angiocrine, Loxo-Lilly Educational grants: S. Ma AstraZeneca, Janssen, Therapeutics CCO, Curio Science, Dava Oncology, Medscape, OncLive, Juno, Loxo Pharmacyclics N. Shah Kite/Gilead, Loxo/Lilly, Seattle Genetics, Juno/BMS, Miltenyi Biotec Tundra Biotec, Adaptive Biotechnologies P. A. Riedell BeiGene, ADC Takeda Pharmaceutical Company, Inc./Gilead, Sana Biotechnology, Nektar Nurix Intellia CVC Caremark, Genmab Novartis MorphoSys, Calibr, Tessa Fate Xencor, Pharmaceuticals Corporation Inc./Gilead J. Schuster Nordic Nanvector, Acerta Pharma/AstraZeneca, Loxo, Genetech/Roche, Regeneron, MustangBio Biotechnologies, Merck, DTRM Patent Combination Therapies CAR PD-1 Inhibitors (via University Pennsylvania Novartis) L. Eliason Employment leadership position: Wang Tuazon Ou Shi Evidera: paid analysis abstract Employee stocks PPD ThermoFisher X. Ye Evidera; Kenderian Boards: Humanigen, Capstan, Luminary Lentigen, LEAHLabs, Sunesis/Viracta Patents Royalties: MustangBio, Mettaforge, Sendero; DSMB: Humanigen