Ixazomib Plus Standard Therapy in Transplant-Ineligible Patients With Myeloma
Posted: Friday, January 22, 2021
Lenalidomide and dexamethasone (Rd) therapy is often the standard-of-care treatment for transplant-ineligible patients with newly diagnosed multiple myeloma. Thierry Facon, MD, of the Centre Hospitalier Universitaire Lille, France, and colleagues reported a “clinically meaningful” trend in progression-free survival with the addition of the oral proteasome inhibitor in the multicenter, placebo-controlled TOURMALINE-MM2 trial. Improvements in time to disease progression and complete response were also reported during a presentation at the 2020 American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract 551).
In this phase III study, 705 patients with transplant-ineligible newly diagnosed myeloma were enrolled and randomly assigned 1:1 into ixazomib plus Rd (n = 351) or placebo plus Rd (n = 354). Both cohorts were treated with 5 mg of lenalidomide for 21 days and 40 mg of dexamethasone on days 1, 8, 15, and 22. The ixazomib-plus-Rd group received 4 mg of ixazomib on days 1, 8, and 15, and the Rd group received a placebo under the same regimen. Dexamethasone was discontinued after 18 cycles, and 3 mg of ixazomib and 10 mg of lenalidomide were continued until toxicity or disease progression.
High-risk cytogenetics was reported in 23.8% of patients of those given ixazomib and 18% of those who were not. Median progression-free survival with the ixazomib combination therapy versus the placebo combination was 35.3 versus 21.8 months, respectively. A total of 169 patients given ixazomib plus Rd and 209 patients given placebo plus Rd either experienced disease progression or died during treatment. The overall response rates were 82.1% and 79.7% with and without ixazomib, respectively.
Treatment-emergent adverse events of grade 3 or greater were reported in 88% and 81% of those given ixazomib and those not given the proteasome inhibitor. Serious treatment-emergent adverse events occurred in 66% and 62% of patients in the ixazomib and placebo groups, respectively.
Disclosure: For full disclosures of the study authors, visit ash.confex.com.