Sanofi has shared positive results from a late-stage study of its anti-CD38 monoclonal antibody Sarclisa (isatuximab) in patients with newly diagnosed multiple myeloma (MM) who are not eligible for transplant.
The phase 3 IMROZ trial has been evaluating the investigational use of drug in combination with standard-of-care bortezomib, lenalidomide and dexamethasone (VRd) followed by Sarclisa-Rd.
The results, presented at this year’s American Society of Clinical Oncology Annual Meeting, demonstrated a 40% reduction in the risk of disease progression or death in patients treated with the Sarclisa/VRd regimen compared to VRd alone.
The median progression-free survival (PFS) with the Sarclisa/VRd treatment arm was not reached after a median follow up of 59.7 months versus 54.3 months with Vrd, and the estimated PFS at 60 months was 63.2% for patients treated with Sarclisa/VRd versus 45.2% for those receiving VRd.
Benefits were also seen across the trial’s secondary endpoints, with approximately 74.7% of patients in the Sarclisa/VRd cohort achieving a complete response (CR) compared to 64.1% of those in the VRd group, and 55.5% of Sarclisa/VRd-treated patients reaching minimal residual disease (MRD) negative CR compared to 40.9% of those receiving Vrd.
MRD negativity lasted for at least a year in 46.8% of patients in the Sarclisa/VRd arm compared to 24.3% of patients taking Vrd.
IMROZ principal investigator, Thierry Facon, Lille University Hospital, said: “Effective frontline therapy has the potential to modify the course of the disease, which is a key outcome for transplant-ineligible patients who often face high rates of attrition in later lines of therapy.
“The IMROZ results demonstrate the promise of Sarclisa as a backbone to frontline therapy, which may improve long-term outcomes for this incurable disease.”
Multiple myeloma (MM) is the second most common haematological malignancy, with more than 180,000 new cases of the disease diagnosed globally every year.
Despite available treatments, MM remains incurable and newly diagnosed patients have a five-year survival rate of about 52%.
Sanofi’s Sarclisa, which holds approvals to treat certain patients with relapsed refractory MM and previously treated MM, is designed to bind to a specific epitope on the CD38 receptor on MM cells and induce distinct anti-tumour activity.
The US Food and Drug Administration has already accepted for Priority Review a supplemental Biologics License Application for the Sarclisa/VRd combination as a treatment for patients with transplant-ineligible NDMM, and a regulatory submission is also under review in the EU.