Adding Takeda’s oral ixazomib to lenalidomide and dexamethasone significantly improved progression-free survival, with limited additional toxicity, in patients with relapsed/refractory multiple myeloma, according to results of a Phase III trial published in the New England Journal of Medicine.
The 722-patient TOURMALINE-MM1 trial demonstrated a statistically significant and clinically meaningful (35 percent) improvement in PFS at a median follow-up of 14.7 months (20.6 months for ixazomib/lenalidomide/dexamethasone [IRd] versus 14.7 months in placebo-Rd control group).
In addition, overall response rate and at least very good partial response rates were 78.3 percent versus 71.5 percent and 48.1 percent versus 39.0 percent, respectively.
“This is the first time data has been published supporting an all-oral triplet regimen containing a proteasome inhibitor in multiple myeloma,” noted Matthew Jenner, trial investigator and consultant haematologist, Southampton General Hospital.
“The results could represent a significant advance for multiple myeloma patients in the UK, as it shows that ixazomib in combination with lenalidomide and dexamethasone is an effective and tolerable oral regimen with a manageable safety profile for patients with relapsed and/or refractory multiple myeloma with benefits seen across all cytogenetic risk groups.”
“Not only do the data show a progression free survival benefit in a difficult-to-treat stage of myeloma, but the all-oral treatment regimen also provides a more convenient way to take medication with less hospital visits and a potential health service benefit,” added Eric Low, chief executive of the charity Myeloma UK.
More than 5,000 people each year in the UK are diagnosed with MM, with more men than women being affected by the disease, and around 2,700 people die from the disease.
Ixazomib was recently approved by the US Food and Drug Administration and is currently under review by the European Medicines Agency.