Impact of ixazomib-lenalidomide-dexamethasone therapy on overall survival in multiple myeloma patients: Analysis of the emerging-markets subgroup of the TOURMALINE-MM1 trial

eJHaem

article

Andrew Spencer¹  Olga Samoilova²  Wee-Joo Chng³  Richard Labotka⁴  Cong Li⁴  Kwang-Wei Wu⁵  Nakul Saxena⁵  Xu Yan⁷  Jae Hoon Lee⁸  Meral Beksac⁹ 

[1] The Alfred Hospital-Monash University;State Budget Institution of Healthcare of Nizhny Novgorod Region, Nizhny Novgorod Regional Clinical Hospital;National University Hospital;Takeda Development Center Americas;Takeda Pharmaceuticals International AG;KWW was an employee of Takeda Pharmaceuticals during the time of this study and is currently an employee of Janssen Pharmaceuticals;State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College;Gachon University Gil Medical Center;Department of Hematology, Ankara University School of Medicine

关键词: emerging-markets;    ixazomib;    multiple myeloma;    overall survival;    proteasome inhibitor;   

DOI  :  10.1002/jha2.548

来源: Wiley

【 摘 要 】

Ixazomib-lenalidomide-dexamethasone (ixazomib-Rd) showed clinical efficacy over placebo-Rd in patients with relapsed/refractory multiple myeloma (MM) in the TOURMALINE-MM1 trial. Over a median follow-up of ∼85 months, as patients showed disease progression, they received subsequent novel therapies that confounded the overall survival (OS) benefit. Here, we conducted a post hoc analysis in 148 patients from seven countries defined as emerging markets, with limited access to novel therapies for MM during the trial period, to describe the impact of these therapies on OS. Patients were randomised to ixazomib-Rd ( n = 71) or placebo-Rd ( n = 77). The median progression-free survival (PFS) was 18.7 versus 10.2 months, with ixazomib-Rd versus placebo-Rd (hazard ratio [HR], 0.504; p = 0.008) demonstrating a statistically significant improvement as observed in the primary trial. The median OS improved by 32.6 months with ixazomib-Rd over placebo-Rd (63.5 vs. 30.9 months; HR, 0.794; p = 0.261); however, the statistically significant benefit seen in PFS was not observed for OS. Improvement with ixazomib-Rd over placebo-Rd was observed in overall response (81.7% vs. 64.9%; odds ratio [OR], 2.38; p = 0.019) and complete response (22.5% vs. 3.9%; OR, 7.57; p < 0.001). Patient-reported quality of life and use of subsequent therapies were similar across treatment groups. No new safety concerns were identified. Compared with the main cohort, median OS was 10 months longer with ixazomib-Rd and 21 months shorter with placebo-Rd in this subgroup, indicating a clinically meaningful survival benefit of ixazomib-Rd treatment in this patient population with limited access to subsequent novel therapies.

【 授权许可】

Unknown