Sarclisa Approved in US for Newly Diagnosed Multiple Myeloma Patients Ineligible for Transplant

The US Food and Drug Administration (FDA) has granted approval for Sarclisa (isatuximab) in combination with the standard-of-care regimen of bortezomib, lenalidomide, and dexamethasone (VRd) as a first-line treatment for adult patients with newly diagnosed multiple myeloma (NDMM) who are not candidates for autologous stem cell transplant (ASCT). This marks the first anti-CD38 therapy approved in combination with VRd for this patient group, offering a significant improvement in progression-free survival (PFS) by 40% compared to VRd alone.

Multiple myeloma is often diagnosed in individuals aged 65 and older. This demographic faces limited treatment options due to age, frailty, and co-morbidities. Dr. Thomas Martin from the Helen Diller Family Comprehensive Cancer Center pointed out the pressing need for new treatment solutions that can enhance the standard-of-care. The approval is based on the encouraging results from the Phase 3 IMROZ study, which demonstrated that the combination of isatuximab with VRd significantly improved PFS in comparison to VRd alone.

This approval marks Sarclisa's third indication in the US and its first for newly diagnosed patients. Sarclisa had previously been evaluated under the FDA's Priority Review, a designation for treatments showing potential significant improvements in safety or efficacy for serious conditions. The drug is also approved in over 50 countries for treating relapsed or refractory multiple myeloma.

Brian Foard, Executive Vice President and Head of Specialty Care at Sanofi, expressed that since Sarclisa's launch in 2020, the company has aimed to establish it as a leading therapy. The recent FDA approval extends the reach of this potentially transformative therapy to a broader patient population, providing a new option to slow disease progression in adults with newly diagnosed multiple myeloma who are not eligible for transplant.

Supporting the FDA approval, the IMROZ Phase 3 study presented at the American Society of Clinical Oncology (ASCO) 2024 annual meeting and published in The New England Journal of Medicine, showed that Sarclisa-VRd followed by Sarclisa-Rd met the primary endpoint of PFS. This combination reduced the risk of disease recurrence or death by 40% compared to VRd followed by Rd, in patients with NDMM not eligible for ASCT. At a median follow-up of nearly 60 months, the median PFS for Sarclisa-VRd was not reached, compared to 54.3 months for VRd alone. The estimated PFS-rate at 60 months was 63.2% for Sarclisa-VRd versus 45.2% for VRd.

The study also saw Sarclisa-VRd meeting several secondary endpoints, achieving deep responses among the patients. Approximately 74.7% of patients treated with Sarclisa-VRd achieved a complete response or better, compared to 64.1% with VRd alone. Moreover, 55.5% of the patients achieved minimal residual disease (MRD) negative complete response with Sarclisa-VRd, compared to 40.9% with VRd.

The safety profile of Sarclisa in combination with VRd was consistent with previous findings. Common adverse reactions included upper respiratory tract infections, diarrhea, fatigue, and pneumonia. Serious adverse reactions occurred in 71% of patients receiving the combination therapy, with pneumonia being the most frequent serious adverse reaction.

Sanofi is committed to advancing Sarclisa through various ongoing Phase 2 and Phase 3 clinical trials across the multiple myeloma treatment continuum. The company is also exploring a subcutaneous administration method for Sarclisa. These efforts are part of Sanofi's broader strategy to innovate in oncology, focusing on difficult-to-treat cancers and improving patient outcomes. Sarclisa continues to be assessed in multiple clinical studies to establish its effectiveness in various settings and patient populations.