Sarclisa(Isatuximab)

Sarclisa (Isatuximab) is an active substance with ATC Code L01XC38, developed by sanofi-aventis groupe. It is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (PI) and have demonstrated disease progression on the last therapy. The marketing authorisation application was submitted on 30 April 2019, and it holds orphan medicinal product designation number EU/3/14/1268.

In the TCD14079 Part B study, the overall response rate (ORR) was 53.2%, with a 12-month probability of progression-free survival (PFS) of 55.7% and a 12-month probability of overall survival (OS) of 70.6%. For patients without prior daratumumab exposure, the ORR was 60.0%. The median PFS was 11.53 months, with a PFS Hazard Ratio of 0.596 (p-value 0.001). The probability of surviving 12 months was 72% for the experimental arm and 63% for the control arm, with an OS Hazard Ratio of 0.687 (p-value 0.0631).

Safety findings across all isatuximab-treated patients included an overall incidence of infusion-related reactions (IRR) of 46.2%, with Grade ≥3 IRR at 3.5%. Neutropenic complications were observed in 9.4% of patients. The incidence of Grade ≥3 thrombocytopenia was 23.0%, with haemorrhage occurring in 12.7% of patients. A positive ADA response was observed in 2.3% of patients across studies.