Clinical lymphoma, myeloma & leukemia · 2025
Health-Related Quality of Life With Odronextamab Monotherapy for Relapsed/Refractory Follicular Lymphoma in the ELM-2 Study.
Клиническое исследование II фазыСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Tessoulin Benoit, Harnett James, Cho Seok-Goo, Taszner Michał, Kim Tae Min, Novelli Silvana, Villasboas Jose C, Merli Michele, Jiménez-Ubieto Ana, Poon Michelle, Tucker David, Walewski Jan, Yi Shuhua, Song Yuqin, Chong Geoffrey, Bachy Emmanuel, Guidez Stephanie, Alonso Aranzazu, Jagadeesh Deepa, Zhang Wei, Magnano Mayer Laura, Iskierka-Jażdżewska Elżbieta, Tani Monica, Cai Jingxian, Ivanescu Cristina, Reaney Matthew, Chaudhry Aafia, Mohamed Hesham, Ambati Srikanth, Chi Lei, Kamat Siddhesh, Luminari Stefano, ELM-2 Investigators
Аннотация
BACKGROUND: In ELM-2, the human CD20 × CD3 bispecific antibody odronextamab was associated with deep, durable responses and a generally manageable safety profile in patients with relapsed/refractory follicular lymphoma (r/r FL).
PATIENTS AND METHODS: Prespecified analyses reported herein examined patient-reported outcomes in ELM-2 among 140 patients with r/r FL.
RESULTS: Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), patients reported good global health status/quality of life (GHS/QoL), functioning, and low symptom burden at baseline, which were generally maintained. Emotional functioning improved significantly overall, with a clinically meaningful change at week 42. Patients were more likely to report clinically meaningful improvement or maintenance than worsening on QLQ-C30 scales. Median time to definitive deterioration (TTDD) was 22.4 months for GHS/QoL, 22.6 months for role functioning, 19.8 months for social functioning, 16.4 months for cognitive functioning, and not reached for physical functioning or emotional functioning. For each QLQ-C30 symptom scale, median TTDD was > 15 months or not reached. On the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) questionnaire, Lymphoma Subscale (LymS) scores improved significantly overall, with clinically meaningful improvement at weeks 26 and 42, and FACT-G, Trial Outcome Index, and Total Score were maintained. Most patients reported either limited or no bother related to side effects of treatment. Visual analog scale scores of the EQ-5D-3L questionnaire improved significantly overall.
CONCLUSION: In this heavily pretreated, highly refractory population, maintenance or improvement of health-related quality of life, functioning, and symptoms support odronextamab as a potential treatment option in R/R FL.
PATIENTS AND METHODS: Prespecified analyses reported herein examined patient-reported outcomes in ELM-2 among 140 patients with r/r FL.
RESULTS: Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), patients reported good global health status/quality of life (GHS/QoL), functioning, and low symptom burden at baseline, which were generally maintained. Emotional functioning improved significantly overall, with a clinically meaningful change at week 42. Patients were more likely to report clinically meaningful improvement or maintenance than worsening on QLQ-C30 scales. Median time to definitive deterioration (TTDD) was 22.4 months for GHS/QoL, 22.6 months for role functioning, 19.8 months for social functioning, 16.4 months for cognitive functioning, and not reached for physical functioning or emotional functioning. For each QLQ-C30 symptom scale, median TTDD was > 15 months or not reached. On the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) questionnaire, Lymphoma Subscale (LymS) scores improved significantly overall, with clinically meaningful improvement at weeks 26 and 42, and FACT-G, Trial Outcome Index, and Total Score were maintained. Most patients reported either limited or no bother related to side effects of treatment. Visual analog scale scores of the EQ-5D-3L questionnaire improved significantly overall.
CONCLUSION: In this heavily pretreated, highly refractory population, maintenance or improvement of health-related quality of life, functioning, and symptoms support odronextamab as a potential treatment option in R/R FL.