Celgene’s ongoing efforts to find additional indications for its multiple myeloma blockbuster Revlimid have suffered another setback after a failed phase III trial in lymphoma.
The RELEVANCE study looked at combining Revlimid (lenalidomide) with Roche’s Rituxan (rituximab) as a first-line treatment for patients with follicular lymphoma, one of the most common types of low-grade non-Hodgkin’s lymphoma (NHL), comparing the duo to the standard therapy of Rituxan plus chemotherapy.
After 120 weeks of follow-up, the study showed no advantage for Revlimid and Rituxan on complete response rates and progression-free survival, dashing hopes that previously-untreated follicular lymphoma patients could be in line for a chemotherapy-free treatment option.
Despite the negative outcome, Professor Gilles Salles, president of the Lymphoma Study Association (LYSA) which backed the study, said it was a “landmark trial” in this disease setting and would help guide future research in follicular lymphoma.
Nevertheless, the result dragged down Celgene’s shares by almost 4.5% yesterday as the data added to concerns that the company will find it much harder than expected to unlock the lymphoma market – which it has previously said could add another $1bn-$1.5bn to Revlimid’s peak sales.
Revlimid has been a cash cow for Celgene for years and is on course to bring in around $8bn this year. However, despite price increases in the US, the drug has seen its sales momentum start to slip back in the face of stiffer competition in its core myeloma market.
Celgene’s efforts to expand its uses have seen come success – including approvals in myelodysplastic syndromes (MDS) and mantle cell lymphoma (MCL) – but also failures. Last year for instance it was unable to show a benefit as a maintenance therapy in patients with diffuse large B-cell lymphoma (DLBCL) in the phase III REMARC trial.
The company does have positive data from the phase IIIb MAGNIFY trial of Revlimid and Rituxan used second-line in relapsed/refractory follicular lymphoma and marginal zone lymphoma, and it has another trial in this setting – AUGMENT – due to report data in the first quarter of 2018.
Celgene president and chief operating officer Scott Smith said recently that the combination “is an opportunity that could bring a chemotherapy-free standard of care to patients in a disease which has the highest incidence among haematologic malignancies.”