Phase 3 trial results for Takeda’s oral proteasome inhibitor ixazomib demonstrate improved survival rates when it is combined with lenalidomide and dexamethasone.
Pivotal TOURMALINE-MM1 results demonstrated that the addition of oral ixazomib to lenalidomide and dexamethasone (IRd) significantly improved progression-free survival, with limited additional toxicity in patients with relapsed / refractory multiple myeloma.
Results from the Phase 3 clinical study, published in the New England Journal of Medicine, have shown that the oral combination is effective in extending progression-free survival (PFS) with a manageable tolerability profile in patients with relapsed and / or refractory multiple myeloma compared to lenalidomide and dexamethasone alone.
This is the first time that data has been published supporting an all-oral triplet regimen containing a proteasome inhibitor in multiple myeloma.
Dr Matthew Jenner, TOURMALINE-MM1 trial investigator and Consultant Haematologist, Southampton General Hospital, said: “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.”
The TOURMALINE-MM1 trial is an international, randomised, double-blind, placebo-controlled Phase 3 clinical trial designed to evaluate once-weekly IRd compared to placebo-Rd for the treatment of patients with MM who have received at least one prior therapy.
Eric Low, Chief Executive of Myeloma UK, said: “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.”