Celgene’s big-selling blood cancer drug Revlimid hit a hurdle this week, failing to meet its objectives in a trial involving patients with diffuse large B-cell lymphoma (DLBCL).
The setback means that Celgene will no longer seek approval for Revlimid (lenalidomide) in this indication – the most common form of non-Hodgkin’s lymphoma (NHL) accounting for around a third of all cases of the disease.
Revlimid was unable to show any benefit over placebo on overall survival rates in the REMARC study when used as a maintenance therapy for patients who had responded to first-line therapy, although it was able to show an improvement in progression-free survival (PFS). PFS alone is not considered compelling as Revlimid carries a risk of serious side effects, including thrombosis.
The product has been a massive success for Celgene with sales reaching $5.8bn last year in its current indications in multiple myeloma and mantle cell lymphoma, with the company predicting an increase to $6.6bn or more for 2016 as a whole.
The company has previously suggested that new indications could expand Revlimid sales by $1bn to $1.5bn by 2020, and Celgene is hoping that four ongoing trials in other forms of lymphoma – notably the RELEVANCE and AUGMENT studies in follicular lymphoma – will help get its plans for the drug back on track.
It is important to note that Celgene is not abandoning Revlimid as a DLBCL therapy just yet. It is also studying the drug in a phase III trial – called ROBUST – that is seeing if the drug has a benefit when added to first-line therapy for a subset of DLBCL patients with a specific molecular marker (ABC-type) that is associated with a poor prognosis.
Michael Pehl, president of haematology and oncology at Celgene, said the company is working to complete the analyses of the REMARC study and remains “committed to finishing the four ongoing phase III trials evaluating Revlimid and are confident about its potential as a treatment option across different settings in lymphoma”.
This is the second time of late that a new drug has stumbled in a DLBCL trial, with Roche’s Gazyvaro (obinutuzumab) also falling short in a study reported last week.