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JCO: Phase 3 TOURMALINE-MM1 trial of patients with relapsed/refractory MM who were treated with ixazomib-lenalidomide-dexamethasone in the final analysis of overall survival

 Last Update: 2021-06-21
 Source: Internet
 Author: User

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The double-blind, placebo-controlled Phase 3 TOURMALINE-MM1 study showed that ixazomib-lenalidomide-dexamethasone (ixazomib-Rd) regimen can significantly improve relapse/refractory multiples compared with placebo-Rd Progression-free survival of patients with myeloma

In this trial, patients were randomly assigned to ixazomib-Rd group (360 people) or placebo-Rd group (362 people), and based on the number of previous treatments (1 vs 2/3), proteasome inhibitor (PI ) Stratification of exposure history (yes vs.

Overall survival of the intention-to-treat population and different subgroups

After a median follow-up of 85 months, the median OS of the ixazomib-Rd group and the placebo-Rd group were 53.

A lower hazard ratio was observed in a predetermined subgroup, suggesting that the ixazomib-Rd regimen has a greater OS benefit compared with placebo-Rd.

Overall survival of patients with various high-risk cytogenetic characteristics

After the study treatment, 71.

The new incidence of primary malignant tumors was similar in the two groups: ixazomib-Rd group (10.

In summary, in this analysis, the progression-free survival benefit of ixazomib-Rd and placebo-Rd did not translate into a statistically significant OS benefit

Subgroup of patients with poor prognostic factors can get greater OS benefit from ixazomib-Rd treatment Subgroup of patients with poor prognostic factors can get greater OS benefit from ixazomib-Rd treatment

Original source:

Paul G.

Final Overall Survival Analysis of the TOURMALINE- MM1 Phase III Trial of Ixazomib, Lenalidomide, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

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