A randomized phase 3 trial designed to evaluate the addition of isatuximab to a standard treatment for patients with relapsed or refractory myeloma met its primary endpoint of PFS.
The multicenter, open-label ICARIA-MM study included 307 patients with relapsed or refractory multiple myeloma treated at 96 centers in 24 countries.
All study participants had received at least two previous therapies, including a minimum two consecutive cycles of lenalidomide (Revlimid, Celgene) and a proteasome inhibitor given alone or in combination.
Researchers assigned patients to standard doses of pomalidomide (Pomalyst, Celgene) and low-dose dexamethasone with or without isatuximab (Sanofi), a CD38-directed monoclonal antibody. Patients received isatuximab via IV infusion at doses of 10 mg/kg once weekly for 4 weeks, followed by every other week for 28-day cycles.
Patients assigned isatuximab achieved longer PFS.
Results of the ICARIA-MM study will be submitted for presentation at a medical meeting, and they are expected to be used as the basis of regulatory submissions later this year, according to a Sanofi-issued press release.
“We are excited by these results, which represent significant progress in our ambition to extend the lives of [patients with] multiple myeloma,” John Reed, head of research and development at Sanofi, said in the release. “We look forward to engaging with regulatory authorities with the goal of bringing this potential new treatment to patients as quickly as possible.”
ICARIA-MM is one of four phase 3 trials underway to evaluate isatuximab in combination with standard treatments for patients with newly diagnosed or relapsed/refractory myeloma. The agent also is under investigation for treatment of other hematologic malignancies and solid tumors.
The FDA granted isatuximab orphan drug designation for relapsed or refractory myeloma.