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Target Oncol. 2017 Aug;12(4):535-542. doi: 10.1007/s11523-017-0504-7.
The oral proteasome inhibitor ixazomib (Ninlaro) is approved in the USA, EU and Japan in combination with lenalidomide and dexamethasone, for the treatment of patients with multiple myeloma (MM) who have received at least one prior therapy. In adults with relapsed and/or refractory MM who had received one to three prior therapies, progression-free survival (PFS) was significantly prolonged in patients who received the ixazomib- versus placebo-based triple therapy in the pivotal, global TOURMALINE-MM1 trial and its regional expansion (China continuation study). A significantly longer time to progression and favourable hazard ratios for PFS were observed across all prespecified subgroups, including patients with high cytogenetic risk. Overall response was achieved in a significantly higher proportion of patients receiving ixazomib- than placebo-based treatment. Ixazomib had a manageable tolerability profile in patients with MM. Ixazomib is the first orally-administered proteasome inhibitor approved for patients with MM, and in combination with lenalidomide and dexamethasone represents an important new option for use in patients with relapsed and/or refractory MM who have previously received at least one prior therapy.
口服蛋白酶体抑制剂伊沙佐米（Ninlaro）在美国、欧盟和日本获批与来那度胺和地塞米松联合使用，用于治疗至少接受过一次治疗的多发性骨髓瘤（MM）患者。在接受过一到三次先前治疗的复发和/或难治性 MM 成人患者中，关键性、全球性 TOURMALINE-MM1 试验及其区域扩展（中国延续研究）中，接受伊沙佐米三联疗法的患者的无进展生存期（PFS）显著延长。在所有预先指定的亚组中，包括细胞遗传学高风险患者，均观察到进展时间延长和 PFS 风险比有利。与接受安慰剂治疗的患者相比，接受伊沙佐米治疗的患者总体缓解率更高。伊沙佐米在 MM 患者中的耐受性良好。伊沙佐米是第一个获批用于 MM 患者的口服蛋白酶体抑制剂，与来那度胺和地塞米松联合使用，为之前至少接受过一次治疗的复发和/或难治性 MM 患者提供了一种重要的新选择。
