{"doi":"10.1002/hon.178_2880","title":"PATIENT‐REPORTED QUALITY OF LIFE (QOL) FOLLOWING TISAGENLECLEUCEL (TISA‐CEL) INFUSION IN ADULT PATIENTS (PTS) WITH RELAPSED/REFRACTORY FOLLICULAR LYMPHOMA (R/R FL)","abstract":"Introduction: Patient-reported QoL is an important endpoint in the single-arm phase II ELARA trial of tisa-cel, which has demonstrated efficacy and favorable safety profiles in adult pts with r/r FL (Fowler NH et al, ASH 2020). Here, we present patient-reported QoL data before and after tisa-cel infusion in ELARA. Methods: Eligible pts (≥18 y) had r/r FL (grades 1-3A) after ≥2 lines of therapy or had failed autologous stem cell transplant (autoSCT). Pts completed the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) and Short Form-36 Health Survey v2 (SF-36) at baseline, and at Months (Mo) 3 and 6 post tisa-cel infusion. For both instruments, a change score >0 indicated improved QoL. Results: As of September 28, 2020, 98 pts were enrolled and 97 received tisa-cel (median follow-up, 10.6 mo); 75% of pts had previously received ≥3 prior lines of therapy and 36% had relapsed after autoSCT. QoL instruments were completed by 79 pts (81%) at baseline, including 69 pts who had a complete or partial response. FACT-Lym and SF-36 assessments were completed by 71 (74%) and 68 (71%) pts at Mo 3 and by 61 (65%) and 60 (64%) pts at Mo 6, respectively. The FACT-Lym subscales showed improvement in the emotional, functional, and physical domains. Furthermore, no deterioration in the social/family domain by Mo 6 was reported, although minimal clinically important differences of 2 were not reached. Similarly, numeric improvement was observed in mean change scores from baseline through Mo 3 for the SF-36 mental health component scores and through Mo 6 for the physical health component scores, including general health, vitality, physical functioning, role-emotional, and role-physical. Overall, 40%-49% of pts demonstrated clinically meaningful improvements in QoL based on FACT-Lym and SF-36 at Mo 3. Furthermore, 68%-83% of pts’ QoL did not deteriorate (Table). Similar trends were observed at Mo 6. Additionally, mean change scores for FACT-Lym improved from baseline to Mo 3 and to Mo 6. Conclusions: These results demonstrate that clinically meaningful improvements in QoL were observed in pts post tisa-cel infusion. The research was funded by: Novartis Pharmaceuticals Corporation Keywords: Indolent non-Hodgkin lymphoma, Cellular therapies Conflicts of interests pertinent to the abstract N. H. Fowler Consultant or advisory role: Roche/Genentech, TG Therapeutics, Verastem, Bayer, Celgene, Novartis Research funding: Roche, Celgene, Gilead Sciences, TG Therapeutics, Novartis, Abbvie, BeiGene M. Dickinson Consultant or advisory role: Novartis, Bristol-Myers Squibb, Gilead Sciences, Roche, Janssen Honoraria: Roche, Amgen, MSD, Janssen, Bristol-Myers Squibb, Novartis Research funding: Novartis, Roche, Takeda, Celgene, MSD Educational grants: Roche Other remuneration: Speakers' Bureau: Novartis J. Martinez-Lopez Consultant or advisory role: Janssen, Novartis, BMS, Incite, Astellas, Glaxo Stock ownership: Altum Sequencing Research funding: BMS, Roche Other remuneration: Speakers' Bureau: Janssen, Novartis, BMS, Incite, Astellas, Glaxo A. Kolstad Consultant or advisory role: Nordic Nanovector Research funding: Merck, Nordic Nanovector Educational grants: Nordic Nanovector S. J. Schuster Consultant or advisory role: Celgene, Nordic Nanovector, Novartis, Abbvie, Acerta Pharma/AstraZeneca, Alimera Sciences, BeiGene, Juno Therapeutics, Loxo Oncology, Tessa Therapeutics, Genentech/Roche Honoraria: Novartis, Celgene Research funding: Novartis, Pharmacyclics, Adaptaive Biotechnologies, Merck, Genentech/Roche, Celgene, Juno Therapeutics, Abbvie, Incyte, TG Therapeutics, DTRM Other remuneration: Patent Combination Therapies of CAR and PD-1 Inhibitors (via University of Pennsylvania with royalties to Novartis) M. Dreyling Consultant or advisory role: Acerta Pharma/AstraZeneca; Bayer/Vital; Celgene/JAzz; Gilead Sciences; Janssen-Cilag; Noavrtis; Roche; Beigene Research funding: Celgene; Janssen-Cilag; Roche-Pharma AG; Abbvie Educational grants: Celgene; Janssen","journal":"Hematological Oncology","year":2021,"id":212005,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":1,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.7218,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2021-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":801963,"name":"Michael Dickinson","orcid":"0000-0002-1492-5966","position":1,"is_corresponding":false},{"id":550142,"name":"Joaquín Martínez‐López","orcid":"0000-0001-7908-0063","position":2,"is_corresponding":false},{"id":673472,"name":"Arne Kolstad","orcid":"0000-0003-2699-3357","position":3,"is_corresponding":false},{"id":273372,"name":"Stephen J. 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