Health-related quality of life with linvoseltamab treatment for relapsed/refractory multiple myeloma in LINKER-MM1.

Linvoseltamab, a human B-cell maturation antigen × CD3 bispecific antibody, showed high efficacy and a generally manageable safety profile in 117 patients with relapsed/refractory multiple myeloma (R/RMM) over a median follow-up of 21.3 months in the LINKER-MM1 trial. Patient-reported health-related quality of life (HRQoL) was assessed at baseline, week 4, and then every 4 weeks, using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30); the 20-item MM module (QLQ-MY20); and the EuroQol 5-dimension, 3-level (EQ-5D-3L) questionnaire. Changes from baseline were estimated overall and at each assessment using mixed models for repeated-measures analysis; clinically meaningful change thresholds were based on previous literature. Results were evaluated by objective response status (at least partial response). Nominal statistically significant improvements from baseline on all QLQ-C30/QLQ-MY20 scales and the EQ-5D-3L visual analog scale were observed overall and at multiple assessments. Improvements in QLQ-C30 Global Health Status/quality of life, fatigue, and pain observed by week 16 were maintained at most subsequent assessments; pain improvement reached the clinically meaningful threshold at week 20 and was generally maintained through week 104. Among 83 treatment responders, nominal statistically significant overall improvements were observed on all scales; nonresponders (n = 34) reported numerical worsening on most scales. Through treatment week 104, improvements in HRQoL measures, including pain, fatigue, and functioning, were reported in patients with triple-class-exposed R/RMM receiving linvoseltamab. Patient-reported benefits were consistent with clinical response, supporting linvoseltamab's favorable benefit-risk profile. This trial was registered at www.clinicaltrials.gov as NCT03761108.