Phase 3 Study Update of Pomalidomide for Heavily Pre-Treated Myeloma
Celgene announced that its Phase 3, multi-center, randomized, open-label study (MM-003) of pomalidomide plus low-dose dexamethasone or high-dose dexamethasone in patients with relapsed and/or refractory multiple myeloma was reviewed by a data safety monitoring board (DSMB), who determined the trial met the primary endpoint of improvement in progression-free survival (PFS) at the PFS final analysis.
The study compared pomalidomide plus low-dose dexamethasone to high-dose dexamethasone in patients who were relapsed on or refractory to at least two prior therapies that must have included both lenalidomide (Revlimid; Celgene) and bortezomib (Velcade; Millennium). Patients in the pomalidomide arm received 4mg of oral pomalidomide on Days 1–21 of each 28-day cycle, with patients ≤75 years also receiving 40mg of oral low-dose dexamethasone and patients >75 years receiving 20mg oral low-dose dexamethasone on Days 1, 8, 15 and 22 of each 28-day cycle, until disease progression. Patients in the comparator arm ≤75 years received 40mg oral high-dose dexamethasone on Days 1–4, 9–12 and 17–20 of each 28-day cycle, and patients >75 years received 20mg oral high-dose dexamethasone on Days 1–4, 9–12 and 17–20 of a 28-day cycle, until disease progression.
The key secondary endpoint of the study was overall survival (OS; with alpha control), and other secondary endpoints included safety, response rates and time to progression. At the OS interim analysis, the study crossed the superiority boundary for OS. Improvements in PFS and OS were both highly statistically significant and clinically meaningful. As a result, the DSMB recommended that patients who had not yet progressed in the high-dose dexamethasone arm should be crossed-over to the pomalidomide plus low-dose dexamethasone arm.
Pomalidomide is an IMiDs compound.
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