ASCO 2024: Sanofi’s Sarclisa seeks multiple myeloma advantage

Sarclisa, a CD38-directed cytolytic human monoclonal antibody, was initially approved by the FDA for treating adults with multiple myeloma (MM). Sanofi recently reported that the US Food and Drug Administration (FDA) has accepted its supplemental biologics licence application (sBLA) for priority review. This announcement was followed by the release of positive results from the Phase III study of Sarclisa in combination therapy for MM.

The findings, presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, highlighted that Sarclisa, when used alongside standard treatments bortezomib, lenalidomide, and dexamethasone (VRd), reduced the risk of disease progression or death by 40% compared to the VRd comparator group alone. This data comes from the Phase III IMROZ study (NCT03319667), which included 446 patients newly diagnosed with transplant-ineligible MM. The primary goal of the study was progression-free survival (PFS). The 60-month estimated PFS was 63.2% for the Sarclisa group, compared to 45.2% for the comparator group. Notably, the trial median PFS has not yet been reached.

Sarclisa is the first anti-CD38 combination therapy shown to significantly improve PFS in newly diagnosed, transplant-ineligible MM patients. Secondary endpoints of the IMROZ study included complete response rate (CR), minimal residual disease (MRD) negativity for those with a complete response, very good partial response (VGPR) or better rate, and overall survival (OS). Results showed that 74.7% of patients treated with Sarclisa/VRd achieved a CR, and 55.5% reached MRD negativity, with 46.8% maintaining MRD negativity for at least 12 months. By comparison, in the VRd active comparator group, 64.1% achieved CR, and 40.9% reached MRD negativity, with 24.3% maintaining it for the same period.

Sarclisa continued to demonstrate a consistent safety and tolerability profile with no new safety issues. Initially approved in 2021 for adults with MM, Sarclisa is expected to generate global sales of $887 million by 2030, according to GlobalData's forecasts. However, the treatment will face significant competition from J&J's Darzalex (daratumumab), another anti-CD38 treatment, which is anticipated to achieve $17.5 billion in sales by 2029.

Despite the competitive landscape, Sarclisa's recent clinical trial results position it as a strong contender in the treatment of MM, particularly for patients who are newly diagnosed and transplant-ineligible. With its demonstrated ability to improve PFS and high rates of CR and MRD negativity, Sarclisa offers a promising option for a challenging form of cancer. The continued focus on safety and efficacy in ongoing studies will be crucial as Sanofi seeks to expand Sarclisa's application and improve outcomes for MM patients.