他克莫司与现实世界中医生选择的治疗方法：三类药物暴露的复发性/难治性多发性骨髓瘤患者的疗效比较。

IF 2.7 4区医学 Q2 HEMATOLOGY

Clinical Lymphoma, Myeloma & Leukemia Pub Date : 2025-02-01 DOI:10.1016/j.clml.2024.08.003

Jing Christine Ye , Noa Biran , Sandhya Nair , Xiwu Lin , Keqin Qi , Anil Londhe , Eric Ammann , Thomas Renaud , Colleen Kane , Trilok Parekh , Kathleen Gray , Steve Peterson , Luciano J. Costa

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引用次数: 0

摘要

背景：他克单抗被批准用于治疗复发/难治性多发性骨髓瘤（RRMM）的三类暴露（TCE）患者。我们评估了MonumenTAL-1研究中的他昔单抗与现实世界中医生选择（RW）治疗的疗效比较：MonumenTAL-1 的外部对照组由 Flatiron Health 数据库中符合 MonumenTAL-1 资格标准的患者组成（n = 629，1169 个符合条件的治疗方案）。MonumenTAL-1的患者水平数据包括接受皮下注射talquetamab 0.4 mg/kg QW（n = 143）和0.8 mg/kg Q2W（n = 145）的患者。调整基线协变量不平衡后，评估了无进展生存期（PFS）、下次治疗时间（TTNT）和总生存期（OS）的比较效果：结果：经调整后，各组群的基线协变量具有可比性。Talquetamab 0.4 mg/kg QW队列和0.8 mg/kg Q2W队列的PFS（HR，0.55 [95% CI，0.44-0.69；P < .0001；中位数，7.5个月对4.0个月]和0.40 [95% CI，0.31-0.53；P < .0001；中位数，14.2个月对4.0个月]）、TTNT（HR，0.59 [95% CI，0.47-0.74；P < .0001；中位数，9.2个月对4.0个月]）和OS均有显著改善。0001; 中位数，9.1 个月 vs. 5.1 个月] 和 0.45 [95% CI, 0.35-0.59; P < .0001; 中位数，13.3 个月 vs. 5.1 个月]），以及 OS（与 RW 治疗相比，HR，0.56 [95% CI, 0.40-0.78; P = .0007; 中位数，NR vs. 16.5 个月] 和 0.48 [95% CI, 0.33-0.70; P = 0.0002; 中位数，NR vs. 15.9 个月]）：结论：在所有评估结果中，两种talquetamab治疗方案的疗效均优于RW治疗方案。这些数据表明，在TCE RRMM患者中，talquetamab是一种有效的免疫疗法。

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Talquetamab Versus Real-World Physician's Choice Treatment: Comparative Effectiveness in Patients With Triple-Class Exposed Relapsed/Refractory Multiple Myeloma

Background

Talquetamab is approved for treatment of triple-class exposed (TCE) patients with relapsed/refractory multiple myeloma (RRMM). We evaluated the comparative effectiveness of talquetamab in the MonumenTAL-1 study versus real-world physician's choice (RW) treatment.

Materials and Methods

An external control arm for MonumenTAL-1 was created from patients in the Flatiron Health database who satisfied MonumenTAL-1 eligibility criteria (n = 629 with 1169 eligible lines of therapy). Patient-level data from MonumenTAL-1 were included for patients who received subcutaneous talquetamab 0.4 mg/kg QW (n = 143) and 0.8 mg/kg Q2W (n = 145). After adjusting for baseline covariate imbalances, comparative effectiveness was assessed for progression-free survival (PFS), time to next treatment (TTNT), and overall survival (OS).

Results

Baseline covariates were comparable across cohorts after adjustment. Talquetamab 0.4 mg/kg QW and 0.8 mg/kg Q2W cohorts, respectively, showed significant improvement in PFS (HR, 0.55 [95% CI, 0.44-0.69; P < .0001; median, 7.5 vs. 4.0 months] and 0.40 [95% CI, 0.31-0.53; P < .0001; median, 14.2 vs. 4.0 months]), TTNT (HR, 0.59 [95% CI, 0.47-0.74; P < .0001; median, 9.1 vs. 5.1 months] and 0.45 [95% CI, 0.35-0.59; P < .0001; median, 13.3 vs. 5.1 months]), and OS (HR, 0.56 [95% CI, 0.40-0.78; P = .0007; median, NR vs. 16.5 months] and 0.48 [95% CI, 0.33-0.70; P = 0.0002; median NR vs. 15.9 months]) versus RW treatment.

Conclusion

Both talquetamab schedules demonstrated superior effectiveness over RW treatment for all outcomes assessed. These data suggest talquetamab as an effective immunotherapy option in patients with TCE RRMM.

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来源期刊

Clinical Lymphoma, Myeloma & Leukemia ONCOLOGY-HEMATOLOGY

CiteScore

2.70

自引率

3.70%

发文量

1606

审稿时长

26 days

期刊介绍： Clinical Lymphoma, Myeloma & Leukemia is a peer-reviewed monthly journal that publishes original articles describing various aspects of clinical and translational research of lymphoma, myeloma and leukemia. Clinical Lymphoma, Myeloma & Leukemia is devoted to articles on detection, diagnosis, prevention, and treatment of lymphoma, myeloma, leukemia and related disorders including macroglobulinemia, amyloidosis, and plasma-cell dyscrasias. The main emphasis is on recent scientific developments in all areas related to lymphoma, myeloma and leukemia. Specific areas of interest include clinical research and mechanistic approaches; drug sensitivity and resistance; gene and antisense therapy; pathology, markers, and prognostic indicators; chemoprevention strategies; multimodality therapy; and integration of various approaches.