Empliciti

Empliciti (elotuzumab) is indicated for the treatment of multiple myeloma. In a clinical trial, the median progression-free survival (PFS) for the Empliciti-lenalidomide-dexamethasone (E-Ld) arm was 19.4 months (95% CI: 16.6, 22.2), compared to 14.9 months (95% CI: 12.1, 17.2) for the lenalidomide-dexamethasone (Ld) arm. The PFS Hazard Ratio was 0.70 (95% CI: 0.57, 0.85) with a p-value of 0.0004. The overall response rate (ORR) was 78.5% (95% CI: 73.6, 82.9) for the E-Ld arm and 65.5% (95% CI: 60.1, 70.7) for the Ld arm. The median overall survival (OS) for the E-Ld arm was 36.2 months (95% CI: 36.2, NE) and 34.6 months (95% CI: 29.0, NE) for the Ld arm, with an OS Hazard Ratio of 0.71 (95% CI: 0.54, 0.93).

Safety findings included nonfatal serious adverse events in 64.1% of patients in the E-Ld arm and 55.2% in the Ld arm. Infusion reactions occurred in 10% of patients. Second primary malignancies were observed in 8.2% of the E-Ld arm and 4.7% of the Ld arm. Pneumonia was reported in 15.4% of the E-Ld arm and 11.4% of the Ld arm, and pyrexia in 6.3% of the E-Ld arm.

Empliciti received Breakthrough Therapy Designation on May 12, 2014, and Orphan Medicinal Product Designation on August 09, 2012. The BLA submission date was June 29, 2015, with BLA Number 761035. The recommended dose of Empliciti is 10 mg/kg.