Sanofi has announced its evaluation of Serclisa (isatuximab) in patients with newly diagnosed multiple myeloma who are not eligible for transplantationStandard of care bortezomib, lenalidomide, and dexamethasone (VRD).An update on the Phase 3 IMROZ trial in combination, which met the primary endpoint in a planned interim efficacy analysis. Trial results showed a statistically significant improvement in progression-free survival (PFS) with combined** compared with VRD alone.
The safety and tolerability of Sarclisa observed in this trial are consistent with the established safety profile of SarcLisa and VRD.
Currently, sarclisa has been approved in more than 50 countries, including the United States and the European Union, in combination with pomalidomide and dexamethasone for patients with refractory multiple myeloma. However, the use of combination with VRD in newly diagnosed multiple myeloma that is not suitable for transplantation is in the research phase and has not been fully evaluated by any regulatory agency.
The company said the latest findings will be presented at an upcoming medical conference and form the basis for future regulatory submissions.
The randomized, multicenter, open-label, Phase 3 IMROZ clinical trial enrolled 484 patients with newly diagnosed multiple myeloma who are not transplantable candidates at 104 sites in 21 countries.
During the trial, sarclisa was administered by intravenous infusion at a dose of 10 mg kg once weekly for five weeks in the first 42-day cycle and every two weeks in cycles 2 to 4, in combination with subcutaneous bortezomib, oral lenalidomide, and intravenous or oral dexamethasone.
Then, sarclisa is administered every 2 weeks from Cycles 5 to 17 and every 4 weeks during Cycle 18+ in a 28-day cycle, in combination with standard doses of lenalidomide and dexamethasone, until disease progression, safety is unacceptable, or the patient decides to discontinue the study**.
The primary endpoint of the trial is progression-free survival.
Key secondary endpoints include complete response rate, minimal residual disease negative rate in patients with complete response, very good partial response or better rate, and overall survival.
Other secondary endpoints were: overall response rate, time to progression, duration of response, time to first response, time to best response, progression-free survival in the next line**, progression-free survival by MRD status, incidence of persistent MRD negativity greater than or equal to 12 months, safety, pharmacokinetic profile, immunogenicity, disease-specific and general health-related quality of life, disease and **-related symptoms, health status utility, and health status.
Reference**:p ress release: sarclisa (isatuximab) phase 3 trial met primary endpoint of progression free survival in patients with newly diagnosed multiple myeloma not eligible for transplant', press release. sanofi；Released on December 7, 2023.
Note: The purpose of this article is to introduce medical and health research, and does not make any basis for medication.