A Phase III trial of Sanofi's isatuximab’s has proven successful, showing that the drug achieved the primary endpoint of prolonging progression free survival in patients with relapsed/refractory multiple myeloma.
The results refer to isatuximab in combination with pomalidomide and low dose dexamethasone compared to pomalidomide and low-dose dexamethasone alone.
The study was randomised, multi-center, and open label, enrolling 307 patients with relapsed/refractory multiple myeloma across 96 centres and 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.
“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.
Isatuximab targets a specific epitope of CD38 capable of triggering multiple, distinct mechanisms of action that are believed to promote programmed tumour cell death (apoptosis) and immunomodulatory activity.