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• W4283388817 abstract "Background: Because patients with multiple myeloma (MM) have impaired health-related quality of life (HRQoL), it is important that patient-reported outcomes (PROs) are assessed in addition to clinical outcomes. Teclistamab (JNJ-64007957) is a B-cell maturation antigen (BCMA) x CD3 bispecific antibody designed to mediate T cell-induced lysis of BCMA-expressing MM cells. In the phase 1/2 MajesTEC-1 trial, initial results from the pivotal cohort (patients who received ≥3 prior lines of therapy [LOT], including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody) showed that teclistamab was well tolerated with encouraging efficacy. Aims: We report PROs of the pivotal cohort from MajesTEC-1. Methods: MajesTEC-1 included patients aged ≥18 years with documented relapsed/refractory multiple myeloma (RRMM) as per the International Myeloma Working Group diagnostic criteria, progressive/measurable disease, and previous exposure to ≥3 prior LOT. Patients who had received prior anti-BCMA treatment were ineligible. Patients were given weekly subcutaneous teclistamab at the recommended phase 2 dose (1.5 mg/kg with step-up doses of 0.06 and 0.3 mg/kg). PRO assessments were performed at screening and at every even treatment cycle; results for cycles 2-8 are reported here. HRQoL was assessed by EORTC QLQ-C30 (range: 0–100; with higher scores indicating better global health status [GHS] but greater symptom severity [symptom scales]) and EuroQol 5-dimensional descriptive system (using the visual analog scale [VAS] with “0” indicating worst imaginable health state and “100” indicating best imaginable health state). Mixed-effects model with repeated measures was used to determine treatment effect. Meaningful improvement was defined as the proportion of patients with a change of ≥10 points. Kaplan-Meier estimate was used to determine time to worsening. Results: The analysis included 110 patients, with median follow-up duration of 7.8 months. The PRO compliance rates were high at baseline (85–90%) and through treatment cycles 2–8 (80–94%). Overall HRQoL was improved with teclistamab, as shown by improved GHS scores (cycle 2–8) and reduced pain (-4.2 [cycle 2] to -15.1 [cycle 8]; Table), with no overall changes in physical functioning and fatigue. Meaningful improvements from baseline to cycle 8 were observed in GHS (50% of patients), physical function (35%), pain (65%), and fatigue (73%). Meaningful improvement in overall health (VAS) was also observed in 50% of patients. Median time to improvement from baseline was ~1.5 months with longer time to improvement seen for nausea/vomiting and fatigue. Across all symptoms, median time to worsening ranged from 2 months to not estimable. Image:Summary/Conclusion: Teclistamab provided rapid, clinically meaningful improvements in HRQoL in patients with RRMM, which are consistent with clinical outcomes in MajesTEC-1." @default.
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• W4283388817 date "2022-06-01" @default.
• W4283388817 modified "2023-10-18" @default.
• W4283388817 title "P922: HEALTH-RELATED QUALITY OF LIFE WITH TECLISTAMAB, A B-CELL MATURATION ANTIGEN X CD3 BISPECIFIC ANTIBODY, IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA FROM MAJESTEC-1" @default.
• W4283388817 doi "https://doi.org/10.1097/01.hs9.0000846556.04927.df" @default.
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