Results from the TOURMALINE-MM1 Phase 3 clinical study, published in the New England Journal of Medicine, have shown that oral ixazomib capsules in combination with lenalidomide and dexamethasone (IRd) are effective in extending progression-free survival (PFS) with a manageable tolerability profile in patients with relapsed and / or refractory multiple myeloma (MM) compared to lenalidomide and dexamethasone (placebo-Rd) alone.1
Dr Matthew Jenner, TOURMALINE-MM1 trial investigator and Consultant Haematologist, Southampton General Hospital, said: "This is the first time data has been published supporting an all-oral triplet regimen containing a proteasome inhibitor in multiple myeloma. 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.1
Eric Low, Chief Executive of Myeloma UK, said: "The publication of this data in the New England Journal of Medicine gives much needed hope for myeloma patients in the UK. 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."
More than 5,000 people each year in the UK are diagnosed with MM, with more men than women being affected by the disease.2
"The publication of data from the Phase 3 TOURMALINE-MM1 trial is another important milestone for ixazomib, which was recently approved by the FDA and is currently under review by the European Medicines Agency (EMA). This publication is the result of significant progress we have made with proteasome inhibition in multiple myeloma over the last decade and also reflects invaluable efforts from our employees, study investigators, patients and their families," said Jon Neal, Business Unit Director - Oncology, Takeda UK. "The expansive TOURMALINE clinical trial program investigates ixazomib's potential across many multiple myeloma settings, including newly diagnosed patients and maintenance therapy. We look forward to sharing additional ixazomib data from our ongoing TOURMALINE studies in the next few years."
Article: Oral Ixazomib, Lenalidomide, and Dexamethasone for Multiple Myeloma, Philippe Moreau, M.D., et al., New England Journal of Medicine, doi: 10.1056/NEJMoa1516282, published 28 April 2016.