Celgene has new phase III data that could add yet another string to blockbuster Revlimid’s bow – as a treatment for patients with non-Hodgkin’s lymphoma who have relapsed or failed to respond to front-line therapy.
The AUGMENT trial paired Revlimid (lenalidomide) with Roche’s established lymphoma therapy Rituxan (rituximab) in patient with two types of NHL – follicular lymphoma (FL) and marginal zone lymphoma (MZL) – and showed a significant increase in progression-free survival (PFS) compared to Rituxan plus placebo.
There was also a trend towards an improvement in overall survival with Revlimid/Rituxan (known as R2), although the trial still has a while to run and that may reach statistical significance when the data matures.
Celgene is planning to file for approval of Revlimid in the new indication early next year, adding to its current uses in multiple myeloma, mantle cell lymphoma, and anaemia associated with myelodysplastic syndromes from which it generated sales of $8.19bn last year.
It’s something of a bounce back for Celgene after an earlier phase III trial – called RELEVANCE and reported last December – failed to show a benefit for R2 compared to Rituxan and chemotherapy in first-line FL. An earlier read-out in diffuse large B-cell lymphoma (DLBCL) also missed the mark.
Analysts had suggested that could have added $500m to $1bn a year to Revlimid’s sales, but said it was an ambitious trial as Rituxan plus chemo is already highly effective in untreated patients. While R2 seemed to be about as effective as Rituxan plus chemo and seemed to have fewer side effects, the higher price of Revlimid and tougher payer environment made seeking approval without a superiority claim unlikely.
Shifting the emphasis to second-line therapy in AUGMENT was considered an easier win, but likely comes with lesser rewards.
Credit Suisse said after the RELEVANVCE fail that AUGMENT and other Revlimid lymphoma trials – MAGNIFY pairing the drug with Rituxan in relapsed/refractory FL and MZL and ROBUST looking at Revlimid plus chemo in first-line (DLBCL) – could generate $273m for Celgene in 2020.
“Indolent non-Hodgkin lymphomas, such as FL and MZL, are diseases of underlying immune dysfunction with a need for new options beyond currently available therapies,” said Jay Backstrom, chief medical officer for Celgene.
“We are encouraged by the highly significant improvement in progression-free survival observed in this study and look forward to engaging with regulatory authorities as soon as possible.”