On March 31, the U.S. Food and Drug Administration (FDA) extended the indication of isatuximab for use in combination with carfilzomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma (RRMM) who have received one to three prior lines of treatment.
Isatuximab is an anti-CD38 monoclonal antibody previously approved for use in combination with pomalidomide and dexamethasone in patients with RRMM who have received at least two prior therapies.
Approval is supported by the randomized phase 3 IKEMA study of 302 patients with RRMM. The addition of isatuximab to carfilzomib plus dexamethasone offered a 45% reduction in disease progression or death compared to carfilzomib plus dexamethasone alone. The overall response rate to the isatuximab combination was 86.6%, with 39.7% of patients achieving a complete response. The median progression-free survival for the isatuximab combination was not yet met at the time of analysis.
The most common adverse events (AEs), occurring in ≥20% of patients, include respiratory tract infection, infusion-related reactions, fatigue, hypertension, diarrhea, pneumonia, dyspnea, bronchitis, and cough. Treatment was discontinued due to AEs in 8% of patients, and due to infection in 2.8% of patients.
“Treatment of patients with RRMM remains challenging and the prognosis for patients experiencing multiple relapses unfortunately is poor,” said Peter C. Adamson, MD, Global Development Head of Oncology and Pediatric Innovation at Sanofi, in a press release. “With this approval, [isatuximab] is now included in two standard of care regimens for the treatment of patients with MM as early as first relapse.”