Celgene: FIRST trial meets primary endpoint in patients newly diagnosed with multiple myeloma

Dec 11 2013

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 55^th 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.

Professor Jamie Cavenagh, Clinical Lead in Haemato-Oncologist at St Bartholomew’s Hospital, London and UK National Coordinating Investigator for MM-020 said: “Multiple myeloma is a debilitating condition with a poor prognosis for patients and there is a need to further improve treatment and overall quality of life for patients. The initial results from FIRST are very positive, showing that patients may be able to live longer without their disease progressing and may offer a new standard of care for the treatment of multiple myeloma.”

Safety results from the FIRST trial show that grade 3/4 adverse events in patients taking LEN + LoDex vs. those taking MPT included neutropenia (28% vs. 45%), thrombocytopenia (8% vs. 11%), febrile neutropenia (1% vs. 3%), infection (29% vs. 17%), neuropathy (1% vs. 9%), and deep-vein thrombosis (8% vs. 5%). The incidence of secondary primary malignancies (SPM) was 0.4% in patients taking LEN + LoDex vs. 2.2% in those taking MPT; the overall incidence of solid tumors was identical (2.8%).