Celgene Drug Shows Phase III Promise for Newly Diagnosed Multiple Myeloma
Celgene said today that its Phase III study of Revlimid® (lenalidomide) in combination with dexamethasone met its primary endpoint of progression-free survival (PFS) in patients newly diagnosed with multiple myeloma (MM).
The company said it will cite results from the clinical trial—named MM-020/IFM 07-01 or FIRST® (Front-Line Investigation of Revlimid/Dexamethasone vs. Standard Thalidomide)—in discussions it plans to launch with regulators in the U.S., Europe, and elsewhere about registering the drug for approvals for the new indication.
During FIRST, 1,623 patients who were ineligible for autologous stem cell transplantation were randomized to receive one of three treatment options: continuous oral lenalidomide plus low-dose dexamethasone until disease progression; lenalidomide plus low-dose dexamethasone for eighteen 28-day cycles or 72 weeks; or melphalan, prednisone, and thalidomide for up to twelve 42-day cycles or 72 weeks.
A doublet regimen of continuous Revlimid with low-dose dexamethasone showed a “statistically significant” improvement in PFS compared to patients receiving the comparator arm with a triplet regimen of melphalan, prednisone, and thalidomide. The trial’s secondary endpoints included overall survival, response rate, quality of life, and safety.
In a statement, Celgene released no figures, saying evaluation of safety and efficacy in the treatment arms was ongoing and that study results are planned to be presented at an unspecified upcoming medical meeting.
The Revlimid-dexamethasone combo is already indicated for MM patients who have received at least one prior therapy in nearly 70 countries, including Europe, the Americas, the Middle East, and Asia, and indicated for patients whose disease has progressed after one therapy in Australia and New Zealand.
Revlimid alone is also approved for indications that cover some patients with mantle cell lymphoma (U.S.)and some with transfusion-dependent anemia (U.S., Canada,Switzerland, Australia, New Zealand, Malaysia, Israel, and several Latin American countries).
Revlimid generated $3.767 billion in sales for Celgene last year, up 17% from 2011, and nearly 70% of the company’s total net product sales in 2012.