Sanofi reports positive late-stage Sarclisa results in new multiple myeloma cases

Sanofi has announced encouraging outcomes from an advanced-stage trial of its anti-CD38 monoclonal antibody Sarclisa (isatuximab) for patients newly diagnosed with multiple myeloma (MM) who are ineligible for transplant. The phase 3 IMROZ trial assessed the investigational use of Sarclisa combined with standard-of-care treatments bortezomib, lenalidomide, and dexamethasone (VRd), followed by Sarclisa-Rd.

The data, revealed at the American Society of Clinical Oncology Annual Meeting, indicated a 40% reduction in the risk of disease progression or death for patients treated with the Sarclisa/VRd regimen compared to VRd alone. Specifically, the median progression-free survival (PFS) for patients receiving Sarclisa/VRd was not reached after a median follow-up of 59.7 months, whereas it was 54.3 months for the VRd group. The estimated PFS at 60 months was 63.2% for the Sarclisa/VRd cohort, versus 45.2% for the VRd-only cohort.

In addition to the primary endpoint, secondary endpoints also showed significant benefits. Approximately 74.7% of patients in the Sarclisa/VRd group achieved a complete response (CR) compared to 64.1% in the VRd group. Furthermore, 55.5% of patients treated with Sarclisa/VRd reached minimal residual disease (MRD) negative CR, compared to 40.9% in the VRd group. MRD negativity persisted for at least a year in 46.8% of patients in the Sarclisa/VRd arm, compared to 24.3% in the VRd arm.

Principal investigator Thierry Facon from Lille University Hospital commented on the findings, highlighting the potential of effective frontline therapy to alter the disease course, particularly for transplant-ineligible patients who often face high attrition rates in later treatment stages. He stated, “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 is the second most common hematological malignancy, with over 180,000 new cases diagnosed globally each year. Despite current treatments, MM remains incurable, with newly diagnosed patients having a five-year survival rate of approximately 52%.

Sanofi’s Sarclisa, which is already approved for treating certain patients with relapsed refractory MM and previously treated MM, functions by binding to a specific epitope on the CD38 receptor on MM cells, thereby inducing unique anti-tumor activity. The US Food and Drug Administration has accepted a supplemental Biologics License Application for the Sarclisa/VRd combination for priority review as a treatment for transplant-ineligible newly diagnosed MM patients. A similar regulatory submission is under review in the European Union.

The promising results from the IMROZ trial mark a significant step in the potential improvement of treatment protocols for patients with MM, especially those who are not suitable candidates for transplant. With the positive data backing its efficacy, Sarclisa in combination with VRd could become a new standard of care in this patient population, paving the way for better long-term outcomes in tackling this challenging and incurable disease.