Sanofi's First-Line Combination Therapy Sarclisa Receives FDA Approval with Over Half of Patients Achieving Complete Disappearance of Cancer Cells

Sep 25, 2024 08:03 CST Updated 08:03

Sanofi

Pharmaceutical R&D Developer

▎WuXiEdited by Kant Content Team

Sanofi recently announced,The U.S. FDA has approved the anti-CD38 antibody Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first-line treatment for newly diagnosed multiple myeloma (NDMM) adult patients who are not eligible for autologous stem cell transplantation (ASCT).The press release noted that Sarclisa, when used in combination with the standard treatment VRd, significantly reduced the risk of disease progression or death by 40% in NDMM patients who are not eligible for ASCT compared to VRd alone. According to the press release, Sarclisa is the first CD38-targeted therapy approved by the U.S. FDA to be used in combination with standard treatment for newly diagnosed multiple myeloma adult patients who are not eligible for ASCT.

The FDA approval was based on data from the Phase 3 clinical trial IMROZ, which was recently presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine. In the IMROZ study, Sarclisa in combination with VRd followed by Sarclisa in combination with Rd met the primary endpoint of progression-free survival (PFS) compared to VRd treatment followed by Rd.Compared with the control group, the Sarclisa combination therapy reduced the risk of recurrence or death by 40% in patients (HR=0.60; 95% CI: 0.44-0.81, p=0.0009).At a median follow-up time of 59.7 months, the median PFS for the Sarclisa combination therapy group had not yet been reached, while the median PFS for the active control group was 54.3 months. At 60 months, the estimated progression-free survival rate for the Sarclisa combination therapy group was 63.2%, compared to 45.2% for the control group.

In addition,Approximately three-quarters (74.7%) of patients treated with the Sarclisa combination therapy achieved a complete response (CR) or better., while this value was 64.1% in the VRd group.More than half (55.5%) of patients treated with the Sarclisa combination therapy achieved minimal residual disease (MRD)-negative CR., while the VRd group was 40.9%.

Sarclisa (isatuximab) is a monoclonal antibody that exerts unique anti-tumor activity by binding to a specific epitope of the CD38 receptor on multiple myeloma cells.It works through multiple mechanisms, including inducing programmed death of tumor cells and immunomodulatory activity.

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References:

[1] Press Release: Sarclisa approved in the US as the first anti-CD38 therapy in combination with standard-of-care treatment for adult patients with newly diagnosed multiple myeloma not eligible for transplant. Retrieved September 24, 2024, from https://www.sanofi.com/en/media-room/press-releases/2024/2024-09-20-22-36-34-2949916

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