Ixazomib maintenance prolongs PFS in non-ASCT multiple myeloma
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Maintenance therapy with ixazomib in patients newly diagnosed with multiple myeloma who did not undergo autologous stem cell transplant showed a 34% reduced risk for disease progression or death, according to presented data.
“There are currently no agents specifically approved as maintenance after variable induction therapy for non-transplant patients,” Meletios Dimopoulos, MD, of the National and Kapodistrian University of Athens, said during the presentation at ASCO20 Virtual Scientific Program. “The oral proteasome inhibitor ixazomib [Ninlaro, Takeda] has been previously demonstrated to prolong PFS vs. placebo as post-transplant maintenance therapy with limited cumulative toxicity or impact on quality of life.”
In this phase 3 study, known as the TOURMALINE-MM4 trial, 706 non-ASCT patients newly diagnosed with multiple myeloma who received standard-of-care induction therapy and achieved at least a partial response were randomly assigned to ixazomib (n = 425) or placebo (n = 281) on days 1, 8 and 15 of 28-day cycles for 2 years or less.
Primary endpoint was progression-free survival, according to the abstract. Researchers grouped patients by prior proteasome inhibitor exposure (yes vs. no), pre-induction disease stage (I/II vs. III), age (< 75 years vs. 75 years) and post-induction best response (complete or very good partial response vs. PR).
The median PFS was 17.4 months with ixazomib compared with 9.4 months with placebo at 21.1 months (HR = 0.659; 95% CI, 0.54–0.8), according to the findings. Dimopoulous and colleagues also observed significant PFS benefit in patients who achieved CR/VGPR after induction (25.6 months with ixazomib vs. 12.9 months with placebo; HR = 0.586; 95% CI, 0.449–0.765).
Ixazomib was largely well-tolerated; 37% assigned ixazomib vs. 23% assigned placebo had grade 3 or greater treatment-emergent adverse event . The most common events were nausea (27% vs. 8%), vomiting (24% vs. 4%) and diarrhea (23% vs. 12%), according to the abstract. The researchers reported no cumulative toxicities.
“The feasibility of maintaining long term PI-based therapy and the convenience of oral administration with ixazomib are valued attributes for treatment of the non-transplant population, particularly for elderly patients,” Dimopoulous said. “Ixazomib is the first oral proteasome inhibitor maintenance option for non-transplant newly diagnosed myeloma patients, and it may provide a valuable maintenance option in combination with other agents, such as immunomodulatory drugs and monoclonal antibodies.”
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Dimopoulous MA, et al. Abstract 8527. Presented at: ASCO20 Virtual Scientific Program; May 29-31, 2020.
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