The pivotal Phase 3 trial of isatuximab has met its primary endpoint of prolonging progression free survival in patients with relapsed/refractory multiple myeloma, developer Sanofi has reported.
Full results will be submitted to an upcoming medical meeting and are anticipated to form the basis of regulatory submissions planned for later this year, Sanofi said.
“We are excited by these results, which represent significant progress in our ambition to extend the lives of multiple myeloma patients,” said John Reed, Head of Research and Development at Sanofi.
“We look forward to engaging with regulatory authorities with the goal of bringing this potential new treatment to patients as quickly as possible.”
Multiple myeloma is the second most common hematologic malignancy, with more than 138,0002 new cases worldwide each year. Multiple myeloma remains incurable in the vast majority of patients, resulting in significant disease burden.
ICARIA-MM, the randomised, multi-centre, open label Phase 3 study, enrolled 307 patients with relapsed/refractory multiple myeloma across 96 centres spanning 24 countries.
All study participants received two or more prior anti-myeloma therapies, including at least two consecutive cycles of lenalidomide and a proteasome inhibitor given alone or in combination.
During the trial, isatuximab was administered through an intravenous infusion at a dose of 10mg/kg once weekly for four weeks, then every other week for 28-day cycles in combination with standard doses of pomalidomide and dexamethasone for the duration of treatment.
The safety profile was evaluated as a secondary endpoint.