Sanofi's CD38 antibody succeeds in phase 3 trial

Sanofi's anti-CD38 antibody, Sarclisa, has shown promising results when combined with standard treatments for newly diagnosed multiple myeloma patients who are not eligible for transplants. According to new data presented at the American Society of Clinical Oncology (ASCO), the combination reduced the risk of disease progression or death by 40%.

The phase 3 IMROZ study evaluated the efficacy of Sarclisa in combination with the standard-of-care regimen consisting of bortezomib, lenalidomide, and dexamethasone (VRd). The study included 446 patients from 21 countries. Participants were randomly assigned either to the Sarclisa-VRd group or the VRd group. The primary goal was to measure progression-free survival, while secondary goals included response rates and overall survival.

Results demonstrated that patients treated with the Sarclisa-VRd combination experienced a significant improvement in progression-free survival compared to those receiving only VRd. Additionally, a higher percentage of patients in the Sarclisa-VRd group achieved complete response and minimal residual disease negativity. Following the initial treatment phase, patients continued with a maintenance phase involving Sarclisa and lenalidomide-dexamethasone (Rd).

Sarclisa is a monoclonal antibody that targets the CD38 protein found on multiple myeloma cells. Its efficacy has led the FDA to accept a supplemental Biologics License Application (BLA) for priority review. A similar submission is currently under review in the European Union.

Multiple myeloma is one of the most common blood cancers, with over 180,000 new cases diagnosed worldwide each year. Despite advancements in treatment, the disease remains incurable, with a five-year survival rate of approximately 52% for newly diagnosed patients.

In parallel, other pharmaceutical companies are also focusing on CD38 as a target for new treatments. For instance, Biogen recently acquired Human Immunology Biosciences (HI-Bio) for an upfront payment of $1.15 billion and up to $650 million in potential milestone payments. HI-Bio’s flagship drug, felzartamab, is another anti-CD38 monoclonal antibody but targets rare immune-mediated diseases instead of multiple myeloma.

Felzartamab has shown encouraging results in phase 2 clinical trials for two rare kidney-related autoimmune diseases: primary membranous nephropathy and IgA nephropathy. Additionally, the drug has demonstrated potential in treating antibody-mediated rejection in kidney transplant patients.

Overall, the promising results from the IMROZ study mark a significant step forward in the treatment of multiple myeloma, particularly for patients who are ineligible for transplants. Sarclisa's success in combination with standard treatments offers hope for improved outcomes in a disease that remains one of the most challenging to treat in the field of hematology.