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塔奎塔单抗可改善复发或难治性多发性骨髓瘤患者报告的症状及与健康相关的生活质量:1/2期MonumenTAL-1研究结果

Talquetamab improves patient-reported symptoms and health-related quality of life in relapsed or refractory multiple myeloma: Results from the phase 1/2 MonumenTAL-1 study.

作者信息

Schinke Carolina, Touzeau Cyrille, Oriol Albert, Mateos María-Victoria, Stevens Don, Rasche Leo, Qin Xiang, Kato Kelly, Bathija Sacheeta, Katz Eva G, Gries Katharine S, Campagna Michela, Masterson Tara, Hilder Brandi W, Tolbert Jaszianne, Renaud Thomas, Heuck Christoph, Tomlinson Chalmer, Moreau Philippe, San-Miguel Jesús, Rodríguez-Otero Paula, Chari Ajai

机构信息

Myeloma Center, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA.

Centre Hospitalier Universitaire de Nantes, Nantes, France.

出版信息

Cancer. 2025 Jul 15;131(14):e35927. doi: 10.1002/cncr.35927.

Abstract

BACKGROUND

Talquetamab is the first approved G protein-coupled receptor family C group 5 member D-targeting bispecific antibody for the treatment of triple-class exposed relapsed/refractory multiple myeloma (RRMM) on the basis of results from the phase 1/2 MonumenTAL-1 study (ClinicalTrials.gov identifiers NCT03399799 and NCT04634552). This study describes patient-reported outcomes (PROs) among patients who received talquetamab in MonumenTAL-1.

METHODS

PROs were assessed in phase 2 of MonumenTAL-1. Patients had RRMM with ≥3 prior lines of therapy (proteasome inhibitors, immunomodulatory drugs, and anti-CD38 antibodies). Patients included in these analyses received talquetamab 0.8 mg/kg every other week. PRO assessments included European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS), and Patient Global Impression of Severity (PGIS).

RESULTS

As of January 29, 2024, PRO data were available for 118 patients who received ≥1 dose of talquetamab. Compliance for completion was >95% of patients at baseline and >80% at most posttreatment visits. After an initial worsening in most PROs from baseline through cycle 1, patients reported improvements with continued treatment. At cycle 21, least-squares mean change from baseline showed improvements in global health status (4.9 points) and emotional functioning (12.5 points), along with reductions in pain (11.4 points) and fatigue (4.0 points). The proportion of patients with clinically meaningful improvements or no change from baseline increased throughout treatment. EQ-5D-5L VAS and PGIS scores demonstrated improvement in health-related quality of life.

CONCLUSIONS

These PRO results complement the efficacy and safety profile of talquetamab, which highlights talquetamab as a viable treatment option for patients with triple-class exposed RRMM.

摘要

背景

基于1/2期MonumenTAL-1研究(ClinicalTrials.gov标识符NCT03399799和NCT04634552)的结果,talquetamab是首个获批的靶向G蛋白偶联受体C族第5成员D的双特异性抗体,用于治疗经三类药物治疗的复发/难治性多发性骨髓瘤(RRMM)。本研究描述了在MonumenTAL-1中接受talquetamab治疗的患者的患者报告结局(PROs)。

方法

在MonumenTAL-1的2期评估PROs。患者患有RRMM,既往接受过≥3线治疗(蛋白酶体抑制剂、免疫调节药物和抗CD38抗体)。纳入这些分析的患者每两周接受一次0.8mg/kg的talquetamab治疗。PRO评估包括欧洲癌症研究与治疗组织生活质量问卷核心30项(EORTC QLQ-C30)、欧洲五维健康量表5级视觉模拟量表(EQ-5D-5L VAS)和患者总体严重程度印象(PGIS)。

结果

截至2024年1月29日,有118名接受≥1剂talquetamab治疗的患者的PRO数据可用。基线时患者完成评估的依从率>95%,大多数治疗后访视时>80%。在从基线到第1周期大多数PROs最初恶化后,患者报告随着持续治疗症状有所改善。在第21周期,与基线相比的最小二乘均值变化显示总体健康状况改善(4.9分)、情绪功能改善(12.5分),同时疼痛(11.4分)和疲劳(4.0分)减轻。在整个治疗过程中,临床意义上改善或与基线无变化的患者比例增加。EQ-5D-5L VAS和PGIS评分显示健康相关生活质量有所改善。

结论

这些PRO结果补充了talquetamab的疗效和安全性概况,突出了talquetamab作为经三类药物治疗的RRMM患者的一种可行治疗选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ed3b/12239699/df41e15b0cc3/CNCR-131-e35927-g001.jpg

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