PMID- 36149968 OWN - NLM STAT- MEDLINE DCOM- 20221202 LR - 20221213 IS - 2473-9537 (Electronic) IS - 2473-9529 (Print) IS - 2473-9529 (Linking) VI - 6 IP - 23 DP - 2022 Dec 13 TI - Health-related quality of life with lisocabtagene maraleucel vs standard of care in relapsed or refractory LBCL. PG - 5969-5979 LID - 10.1182/bloodadvances.2022008106 [doi] AB - Lisocabtagene maraleucel (liso-cel) has shown promising efficacy in clinical trials for patients with relapsed/refractory large B-cell lymphoma (LBCL). We present health-related quality of life (HRQOL) results from the TRANSFORM study, the first comparative analysis of liso-cel vs standard of care (SOC) as second-line therapy in this population. Adults with LBCL refractory or relapsed /=1 postbaseline assessment were analyzed (liso-cel, n = 47; SOC, n = 43). The proportion of patients with meaningful improvement in global health status/quality of life (QOL) was higher, whereas deterioration was lower in the liso-cel arm vs SOC arm from day 126 to month 6. Mean change scores showed meaningful worsening in global health status/QOL at month 6, fatigue at day 29 and month 6, and pain at month 6 with SOC; mean scores for other domains were maintained or improved in both arms. Time to confirmed deterioration favored the liso-cel arm vs SOC arm in global health status/QOL (median: not reached vs 19.0 weeks, respectively; hazard ratio, 0.47; 95% confidence interval, 0.24-0.94). HRQOL was either improved or maintained from baseline in patients with relapsed/refractory LBCL in the liso-cel arm vs SOC arm as second-line treatment. This study is registered at clinicaltrials.gov as #NCT0357531. CI - (c) 2022 by The American Society of Hematology. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), permitting only noncommercial, nonderivative use with attribution. All other rights reserved. FAU - Abramson, Jeremy S AU - Abramson JS AUID- ORCID: 0000-0001-8467-9257 AD - Lymphoma Program, Massachusetts General Hospital Cancer Center, Boston, MA. FAU - Johnston, Patrick B AU - Johnston PB AD - Division of Hematology, Mayo Clinic, Rochester, MN. FAU - Kamdar, Manali AU - Kamdar M AD - Division of Hematology, Hematologic Malignancies and Stem Cell Transplantation, University of Colorado Cancer Center, Aurora, CO. FAU - Ibrahimi, Sami AU - Ibrahimi S AD - Transplant and Cellular Therapy Clinic, University of Oklahoma Stephenson Cancer Center, Oklahoma City, OK. FAU - Izutsu, Koji AU - Izutsu K AD - Department of Hematology, National Cancer Center Hospital, Tokyo, Japan. FAU - Arnason, Jon AU - Arnason J AD - Department of Hematology/Oncology, Beth Israel Deaconess Medical Center, Boston, MA. FAU - Glass, Bertram AU - Glass B AD - Department of Hematology and Cell Therapy, Helios Klinikum Berlin-Buch, Berlin, Germany. FAU - Mutsaers, Pim AU - Mutsaers P AD - Department of Hematology, Erasmus University Medical Center, Rotterdam, The Netherlands. FAU - Lunning, Matthew AU - Lunning M AD - Hematology/Oncology Division, University of Nebraska Medical Center, Omaha, NE. FAU - Braverman, Julia AU - Braverman J AD - Bristol Myers Squibb, Princeton, NJ. FAU - Liu, Fei Fei AU - Liu FF AUID- ORCID: 0000-0003-3364-0808 AD - Bristol Myers Squibb, Princeton, NJ. FAU - Crotta, Alessandro AU - Crotta A AD - Celgene, a Bristol-Myers Squibb Company, Boudry, Switzerland. FAU - Montheard, Sandrine AU - Montheard S AD - Celgene, a Bristol-Myers Squibb Company, Boudry, Switzerland. FAU - Previtali, Alessandro AU - Previtali A AD - Celgene, a Bristol-Myers Squibb Company, Boudry, Switzerland. FAU - Guo, Shien AU - Guo S AD - Clinical Outcome Assessment, Evidera, Waltham, MA. FAU - Shi, Ling AU - Shi L AD - Clinical Outcome Assessment, Evidera, Waltham, MA. FAU - Solomon, Scott R AU - Solomon SR AD - Transplant and Cellular Immunotherapy Program, Northside Hospital Cancer Institute, Atlanta, GA. LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - Blood Adv JT - Blood advances JID - 101698425 SB - IM MH - Adult MH - Humans MH - Quality of Life MH - Standard of Care MH - Antineoplastic Combined Chemotherapy Protocols/therapeutic use MH - *Hematopoietic Stem Cell Transplantation MH - Transplantation, Autologous MH - *Lymphoma, Large B-Cell, Diffuse PMC - PMC9713278 COIS- Conflict-of-interest disclosure: J.S.A. reports consultancy from AbbVie, Allogene Therapeutics, AstraZeneca, BeiGene, Bluebird Bio, Bristol Myers Squibb, C4 Therapeutics, Celgene, a Bristol-Myers Squibb Company, Eli Lilly, EMD Serono Inc., Genentech, a member of the Roche Group, Genmab, Incyte Corporation, Karyopharm Therapeutics, Kite Pharma, Kymera Therapeutics, MorphoSys, Novartis, and Regeneron; and research grants from Bristol-Myers Squibb and Seagen Inc. M.K. reports consultancy from AbbVie, Adaptive Biotechnologies, ADC Therapeutics, AstraZeneca, BeiGene, and Bristol Myers Squibb; honoraria from Seagen; and grants for research from Genentech and TG Therapeutics. S.I. reports divested equity in a private or publicly-traded company in the past 24 months from Karyopharm Therapeutics. K.I. reports honoraria from Daiichi Sankyo, Eisai, Fuji Film Toyama Chemical, Janssen, Kyowa Kirin, Novartis, Ono Pharmaceutical, Symbio, Takeda, Chugai, Celgene, AstraZeneca, Allergan Japan, and AbbVie and research funding from Daiichi Sankyo, Eisai, Genmab, Incyte, Huya Biosciences, Janssen, Kyowa Kirin, MSD, Novartis, Ono Pharmaceutical, Pfizer, Solasia, Takeda, Yakult, Chugai, Celgene, BeiGene, Bayer, and AstraZeneca. J.A. reports honoraria from Juno Therapeutics, a Bristol-Myers Squibb Company. B.G. reports consultancy from Bristol-Myers Squibb and Roche; research funding from Riemser Pharma GmbH. M.L. reports consultancy from Karyopharm, AstraZeneca, Legend, Verastem, Janssen, Myeloid Therapeutics, Daiichi Sankyo, Novartis, Spectrum, Celgene, a Bristol-Myers Squibb Company AbbVie, Acrotech, BeiGene, ADC Therapeutics, TG Therapeutics, MorphoSys, Kite Pharma, a Gilead Company, and Kyowa Kirin. S.G. is a current employee at Evidera, which received research funding from Bristol Myers Squibb; and reports consultancy from Bristol Myers Squibb, Gilead, and Janssen. L.S. is a current employee at Evidera, which received research funding from Bristol Myers Squibb. J.B., F.F.L., A.C., S.M., and A.P. are current employees and equity holders at Bristol Myers Squibb. The remaining authors declare no competing financial interests. EDAT- 2022/09/24 06:00 MHDA- 2022/12/03 06:00 PMCR- 2022/09/27 CRDT- 2022/09/23 14:04 PHST- 2022/08/29 00:00 [accepted] PHST- 2022/05/16 00:00 [received] PHST- 2022/09/24 06:00 [pubmed] PHST- 2022/12/03 06:00 [medline] PHST- 2022/09/23 14:04 [entrez] PHST- 2022/09/27 00:00 [pmc-release] AID - 486699 [pii] AID - 10.1182/bloodadvances.2022008106 [doi] PST - ppublish SO - Blood Adv. 2022 Dec 13;6(23):5969-5979. doi: 10.1182/bloodadvances.2022008106.