伊萨图西马布,博尔特佐米布,莱纳利多米德和甲用于多发性骨髓瘤
Thierry Facon1, Meletios-Athanasios Dimopoulos1, Xavier P Leleu1
1From the Department of Hematology, Centre Hospitalier Universitaire (CHU) de Lille, University of Lille, Lille (T.F., S. Manier), the French National Academy of Medicine (T.F.), and the Department of Hematology, Hôpital Saint-Antoine, Sorbonne University and INSERM (M.M.), Paris, Service d'Hématologie et Thérapie Cellulaire, CHU and Centre d'Investigation Clinique INSERM Unité 1402, Poitiers (X.P.L.), the Department of Hematology, University Hospital Hôtel-Dieu, Nantes (P.M.), and Sanofi, Research and Development, Vitry-sur-Seine (C.O., M.-F.B., S. Macé, C.B.) - all in France; the Plasma Cell Dyscrasia Unit, Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Athens (M.-A.D.); the Department of Hematology, Ankara University, and the Istinye University Ankara Liv Hospital, Ankara (M.B.), and the Department of Internal Medicine, Istanbul Medical Faculty, Istanbul University, Istanbul (S.K.-B.) - all in Turkey; the Department of Internal Medicine, Hematology, and Oncology, University Hospital Brno, Brno (L.P.), the Department of Hemato-Oncology, University Hospital Ostrava, and the Faculty of Medicine, University of Ostrava, Ostrava (R.H.), the Department of Hemato-Oncology, Faculty of Medicine and Dentistry, Palacký University and University Hospital Olomouc, Olomouc (J.M.), and the Charles University and General Hospital in Prague, Prague (I.S.) - all in the Czech Republic; Shengjing Hospital of China Medical University, Shenyang, China (Z.L.); the Department of Lymphoid Malignancies, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw (J.R.-J.), and the Department of General Hematology, Copernicus Memorial Hospital, Comprehensive Cancer Center and Traumatology, Łódź (P.R.) - both in Poland; the S.P. Botkin Moscow City Clinical Hospital, Moscow (V.I.V.); the Department of Hematology, Oncology, Immunology, and Rheumatology, University Hospital of Tübingen, Tübingen (B.B.), and the Department of Internal Medicine V, University of Heidelberg, Heidelberg (H.G.) - both in Germany; the Japanese Red Cross Medical Center, Tokyo (T.I.); Calvary Mater Newcastle, Newcastle, NSW (W.J.), and the Illawarra Cancer Care Centre, Wollongong, NSW (G.P.) - both in Australia; IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seràgnoli," and Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy (E.Z.); the Division of Hematology-Oncology, University of California, San Francisco, San Francisco (T.G.M.); Sanofi, Patient Safety and Pharmacovigilance, Bridgewater, NJ (D.B.); Sanofi, Cambridge, MA (Z.K.); and the Department of Lymphoma and Myeloma, University of Texas M.D. Anderson Cancer Center, Houston (R.Z.O.).
在新诊断的多发性骨髓瘤患者中,将伊萨图西马布添加到博尔特佐米布,列纳利多米德和德克萨美 (VRd) 显著改善了无进展的存活率,这些患者不符合移植条件. 这种组合疗法表现出卓越的疗效和深度反应,没有新的安全问题.
科学领域:
- 血液学 血液学 血液学
- 在瘤学瘤学.
- 临床试验 临床试验
背景情况:
- 博尔特佐米布,莱纳利多米德和德克萨米松 (VRd) 是新诊断的多发性骨髓瘤的标准一线治疗方法.
- 添加抗CD38单克隆抗体伊萨图西马布 (isatuximab) 添加到移植不合格患者的VRd治疗方案的好处以前是未知的.
研究的目的:
- 在新诊断多发性骨髓瘤的移植不合格患者中,与单独的VRd相比,为VRd疗法添加伊萨图西玛的疗效和安全性进行评估.
主要方法:
- 一项国际,开放标签的第三期试验随机选择了446名移植不合格的患者 (18-80岁) 接受异西马布加VRd或单独VRd.
- 主要终点是无进展的生存期;次要终点包括完全响应率和最小残留疾病 (MRD) 负状态.
主要成果:
- 随访时间中位数为59.7个月,伊萨图西马布-VRd显著改善了60个月无进展生存率 (63.2%对45.2%;HR 0.60,P<0.001).
- 较高的完整反应或更好的率 (74.7%与64.1%,P=0.01) 和MRD阴性状态 (55.5%与40.9%,P=0.003) 被观察到与伊萨图西马布-VRd.
- 两组的安全性概况是可比的,对伊萨图西马布-VRd.没有发现新的安全信号.
结论:
- 伊萨图西马布-VRd对于新诊断的多发性骨髓瘤的移植不合格患者来说,是一种比单独使用VRd更有效的初始疗法.
- 在这种患者群体中,添加伊萨图西马布可以提高反应的深度,并延长无进展的生存期.
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