Sanofi’s Sarclisa approved as first-line for transplant-ineligible multiple myeloma patients

1. Sarclisa in combination with the VRd regiment was superior to VRd alone in improving survival in stem cell transplant ineligible multiple myeloma patients.
2. No significant difference in serious adverse events between control and treatment groups. were reported

The Latest

The results of Sanofi’s phase 3 IMROZ trial have allowed for the expanded indication of Sarclisa. Previously approved only for patients with previously treated multiple myeloma (MM), the FDA has now approved Sarclisa to be used in combination with the existing regiment of bortezomib, lenalidomide and dexamethasone (VRd regiment) for newly diagnosed MM patients ineligible for stem cell transplant. The trial found that Sarclisa + VRd compared to VRd alone reduced risk of death by 40%. The estimated progression free survival at 60 months, that is the surviving rate with disease with no further progression of the disease, was also higher in the Sarclisa + VRd group. There were no significant differences in the incidence of adverse effects during treatment.

Physician’s Perspective

MM is a malignant disorder of immune blood cells called plasma cells. These plasma cells produce an abnormal amount of proteins which can infiltrate various areas in the body leading to variable clinical manifestations. MM can present with fevers, bone pain and back pain, but sometimes can be totally asymptomatic. Left untreated, however, it can lead to significant morbidity and ultimately multi-organ failure. Sarclisa is a game changer in multiple myeloma treatment. While daratumumab, an agent with a similar mechanism of action, has shown success in treatment of transplant ineligible patients as well. Sarclisa offers hope for patient’s who continue to have refractory MM by demonstrating superior efficacy, and comparable tolerably.

Molecular Target of Therapy

CD38 is highly expressed on multiple myeloma cells compared to normal cells which express CD38 at low levels. Sarclisa is a monoclonal antibody that recognizes and binds to a specific epitope (a specific binding site) on CD38 receptors. By binding to this site, Sarclisa can activate various immune responses to target MM cells. It also directly causes apoptosis (cell death) of the MM cells. Additionally, it also enhances the effects of the VRd regiment.

Company History

Sanofi is engaged in the research and development of pharmaceuticals in several areas of medicine. Sanofi’s best-known products include Lantus for diabetes and Plavix for heart attack and stroke prevention. Sanofi’s Dupixent continues to make headways in a variety of indications as a recent phase 3 study showed that Dupixent can be used as add-on maintenance treatment for inadequately controlled COPD patients. This joins a list of other conditions that Dupixent can now treat including eczema, asthma, rhinosinusitis, eosinophilic esophagitis and prurigo nodularis.

Additional Reading: https://www.nejm.org/doi/full/10.1056/NEJMoa2400712