Initial phase III trial results, presented at American Society of Hematology annual meeting, show 28% reduction in risk of progression and 22% reduction in risk of death
Celgene today announced that data from the FIRST (Frontline Investigation of lenalidomide and dexamethasone vs. standard thalidomide) trial was presented on Sunday 8 December, during the Plenary Scientific Session at the 55th American Society Hematology (ASH) annual meeting in New Orleans. FIRST (MM-020/IFM 07-01) a phase III, multi-centre study in patients newly diagnosed with multiple myeloma (ndMM) and ineligible for stem cell transplant, included 72 patients from the UK.
After a median follow-up of 37 months, the trial met its primary endpoint (progression-free survival), demonstrating a 28% reduction in risk of progression and 22% reduction in risk of death (p=0.00006). The pre-planned interim analysis of overall survival demonstrated a 22% reduction in risk of death in favour of those patients receiving lenalidomide plus low-dose dexamethasone (LEN + LoDex) in 28-day cycles until disease progression vs. those patients receiving melphalan, prednisone and thalidomide (MPT) in 42-day cycles for 72 weeks (p=0.0168). However, the pre-specified boundary (p<0.0096) was not crossed. All other secondary endpoints – including overall response rate, time to response, duration of response, safety and quality of life – consistently showed improvement in favour of those patients receiving LEN + LoDex vs. MPT.