EHA25 Virtual: Maintenance Myeloma Therapy With Ixazomib and Without AutoSCT
Posted: Friday, June 26, 2020
In patients with newly diagnosed multiple myeloma who are not undergoing autologous stem cell transplantation (autoSCT), post-induction maintenance therapy with the oral proteasome inhibitor ixazomib reduced the risk of disease progression or death by a “clinically meaningful” 34% compared with a placebo. These findings from the phase III TOURMALINE-MM4 trial were presented by Meletios A. Dimopoulos, MD, of the National and Kapodistrian University of Athens School of Medicine, Greece, and colleagues during the virtual edition of the 25th European Hematology Association (EHA) Annual Congress (EHA25 Virtual; Abstract S200).
In this international, double-blind study, 706 patients with newly diagnosed multiple myeloma were randomly assigned to receive either ixazomib (n = 425) or placebo (n = 281) after 6 to 12 months of standard-of-care induction therapy. They were not candidates for autoSCT. Those assigned to ixazomib received 3 mg during cycles 1 through 4, then 4 mg thereafter if tolerated. Both ixazomib and placebo were given on days 1, 8, and 15 of 28-day cycles for up to 2 years.
A significant improvement in progression-free survival was achieved with ixazomib versus placebo (17.4 vs. 9.4 months, P < .001), as well as in patients with a complete response or a very good partial response after induction therapy (25.6 vs. 12.9 months, P < .001). Progression-free survival also favored ixazomib in multiple patient subgroups, including younger and older than age 75, an International Staging System (ISS) stage I/II disease, ISS stage III disease, and both proteasome inhibitor–exposed and –naive patients.
Treatment-emergent adverse events were reported in 91% and 82% of patients in the ixazomib and placebo arms, respectively. Additionally, 22% and 17%, respectively, had serious treatment-emergent adverse events. Common adverse events with ixazomib included nausea (27%), vomiting (24%), and diarrhea (23%).
Disclosure: The study authors’ disclosure information may be found at library.ehaweg.org.