Improved survival with daratumumab-CyBorD compared with CyBorD as frontline therapy for AL amyloidosis

Blood Neoplasia Pub Date : 2025-03-10 DOI:10.1016/j.bneo.2025.100092

Binoy Yohannan , Matthew Rees , Morie A. Gertz , Angela Dispenzieri , Prashant Kapoor , Francis K. Buadi , David Dingli , Nelson Leung , Martha Q. Lacy , Suzanne R. Hayman , Wilson Gonsalves , Taxiarchis Kourelis , Joselle Cook , Moritz Binder , Mustaqeem Siddiqui , Yi Lin , Lisa Hwa , Michelle G. Rogers , Miriam Hobbs , Amie Fonder , Eli Muchtar

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Abstract

In the ANDROMEDA phase 3 trial, the addition of daratumumab to cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) as frontline therapy significantly improved hematological and organ responses, and event-free survival (EFS) compared with CyBorD. To validate its results, we performed a retrospective study of 361 consecutive patients with newly diagnosed light chain (AL) amyloidosis treated between 2018 and 2022. Patients who received Dara-CyBorD (n = 147) were compared with those treated with CyBorD (n = 214) in key outcome endpoints. The 2-month hematological very good partial response or better rate was higher with Dara-CyBorD than with CyBorD (60.8% vs 31.1%; P < .001). In addition, 2- and 6-month hematological complete response was also higher with Dara-CyBorD (15.3% vs 3.0% and 39.5% vs 17.8%, respectively; both P < .001). Fewer patients treated with Dara-CyBorD required second-line therapy at the 12-month landmark (14.9% vs 42.9%; P < .001). The 6- and 12-month cardiac responses were higher and deeper in the Dara-CyBorD group than in the CyBorD group. Dara-CyBorD was associated with a lower 6-month mortality rate (8.8% vs 16.3%; P = .04) and superior EFS and overall survival (OS). An OS difference between the treatment groups was statistically significant among patients with stage II cardiac disease, and borderline significant for stage IIIA but not for cardiac stage IIIB. In conclusion, the addition of daratumumab to frontline CyBorD significantly improved hematological and organ response rates, reduced early deaths, and prolonged EFS and OS compared with CyBorD.

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达拉单抗-CyBorD作为AL淀粉样变性病的一线疗法与CyBorD相比生存率更高

在ANDROMEDA iii期临床试验中，与CyBorD相比，daratumumab联合环磷酰胺、硼替佐米和地塞米松（Dara-CyBorD）作为一线治疗可显著改善血液学和器官反应，以及无事件生存期（EFS）。为了验证其结果，我们对2018年至2022年间连续治疗的361例新诊断的轻链（AL）淀粉样变性患者进行了回顾性研究。在关键终点上，与接受Dara-CyBorD治疗的患者（n = 147）进行比较。Dara-CyBorD组2个月血液学非常好或更好的部分缓解率高于CyBorD组(60.8% vs 31.1%；P & lt;措施)。此外，达拉- cybord的2个月和6个月血液学完全缓解也更高(分别为15.3%对3.0%和39.5%对17.8%；P <；措施)。接受Dara-CyBorD治疗的患者在12个月里程碑时需要二线治疗的患者较少(14.9% vs 42.9%；P & lt;措施)。与CyBorD组相比，Dara-CyBorD组6个月和12个月的心脏反应更高、更深。Dara-CyBorD与较低的6个月死亡率相关(8.8% vs 16.3%；P = .04)，且有较好的EFS和总生存期（OS）。在II期心脏病患者中，治疗组之间的OS差异具有统计学意义，在IIIA期患者中，OS差异具有临界意义，但在IIIB期患者中，OS差异无统计学意义。总之，与CyBorD相比，在一线CyBorD中加入daratumumab可显著改善血液学和器官反应率，降低早期死亡，延长EFS和OS。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Blood Neoplasia

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