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The Phase 3 Study ECHELON-1 Evaluating Brentuximab Vedotin in Patients With Newly Diagnosed Hodgkin Lymphoma Leaves Important Questions Unanswered

机译:ECHELON-1评估新诊断霍奇金淋巴瘤患者中的Brentuximab Vedotin的3期研究未解决重要问题

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摘要

In 2010, the ( ) published phase I results of brentuximab vedotin (BV), an antibody-drug conjugate targeting CD30. After decades of standstill in the commercial development of new drugs in Hodgkin lymphoma (HL), this pioneering innovation opened up new options in this malignancy affecting mainly young adults. Phase II results of BV in relapsed or refractory (r/r) classical HL (cHL) then revealed an exceptional overall response rate of 75%, which led to approval. This was the first study reporting only positron emission tomography (PET)-based response rates, which were not comparable to results from all previously published studies using computed tomography (CT)-based response assessment. The more relevant progression-free survival (PFS) was less impressive with a median of 5.6 months. Subsequently, BV has been widely used as “bridge-to-transplant” for r/r HL patients. A phase 3 study then proved the activity of single-agent BV as consolidation after high-dose chemotherapy. In this setting, cHL patients treated with BV for 1 year had a significantly better outcome than patients in the placebo control arm. Accordingly, BV has been approved for relapsed cHL patients based on trials without any active comparator.
机译:在2010年,()发表了brentuximab vedotin(BV)(靶向CD30的抗体-药物偶联物)的I期结果。在霍奇金淋巴瘤(HL)新药的商业开发停滞了数十年之后,这项开创性的创新为这种主要影响年轻人的恶性肿瘤开辟了新的选择。 BV在复发性或难治性(HL)经典HL(cHL)中的II期结果随后显示出75%的出色总体响应率,这得到了认可。这是第一项仅报告基于正电子发射断层扫描(PET)的反应率的研究,这与以前使用基于计算机断层摄影(CT)的反应评估的所有发表的研究结果均不具有可比性。更相关的无进展生存期(PFS)令人印象深刻,中位数为5.6个月。随后,BV已被广泛用作r / r HL患者的“桥对移植”。然后,一项3期研究证明了大剂量化疗后单药BV作为巩固药物的活性。在这种情况下,接受BV治疗1年的cHL患者比安慰剂对照组的患者有明显更好的结局。因此,根据没有任何有效比较剂的试验,已批准BV用于复发性cHL患者。

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