Sanofi CD38 antibody delivers in phase 3 trial

June 4, 2024

Sanofi's anti-CD38 antibody, Sarclisa, combined with standard-of-care treatments, reduced the risk of disease progression or death by 40% in newly diagnosed, transplant-ineligible multiple myeloma patients, according to new data shared at ASCO.

The phase 3 IMROZ study compared Sarclisa in combo with the standard-of-care bortezomib, lenalidomide and dexamethasone (VRd) to VRd in newly diagnosed, transplant-ineligible multiple myeloma patients. Sarclisa-VRd significantly improved progression-free survival versus VRd. More patients treated with Sarclisa-VRd achieved a complete response and minimal residual disease negativity. 

The study included 446 patients across 21 countries. Sarclisa was administered alongside VRd, followed by a maintenance phase with Sarclisa-Rd. The primary endpoint was progression-free survival, with secondary endpoints including response rates and overall survival.

Sarclisa is a monoclonal antibody targeting CD38 on multiple myeloma cells. The FDA has accepted a supplemental BLA for priority review, and a similar submission is under review in the EU.

Multiple myeloma is a common hematologic malignancy with over 180,000 new cases diagnosed globally each year. Despite advances in treatment, it remains incurable, with a five-year survival rate of about 52% for newly diagnosed patients.

Other companies are betting on CD38 as well, with Biogen recently acquiring Human Immunology Biosciences for $1.15 billion upfront and up to $650 million in potential milestone payments. HI-Bio’s lead candidate, felzartamab, is a potential first-in-class anti-CD38 monoclonal antibody targeting rare immune-mediated diseases.

The drug has shown promising results in phase 2 trials for two rare autoimmune diseases that affect the kidneys, primary membranous nephropathy and IgA nephropathy, as well as in antibody-mediated rejection in kidney transplants.