Sarclisa: A New Hope for Transplant-Ineligible Multiple Myeloma Patients in the EU

Sanofi's Sarclisa has received a significant boost with its approval in the European Union (EU) as the first anti-CD38 therapy in combination with standard-of-care bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT). This approval marks a crucial milestone in the fight against multiple myeloma, a rare and often fatal blood cancer.

Multiple myeloma is a complex disease that affects the bone marrow, leading to the production of abnormal plasma cells. These cells accumulate in the bone marrow, crowding out healthy cells and causing damage to the bones and other organs. The disease is typically treated with a combination of drugs, including proteasome inhibitors, immunomodulatory drugs, and corticosteroids. However, the prognosis for patients who are not eligible for ASCT remains poor, with a high risk of disease progression and mortality.

Sarclisa, a CD38 monoclonal antibody, has shown promising results in clinical trials when used in combination with VRd. The IMROZ phase 3 study, which formed the basis of the regulatory submissions, demonstrated that Sarclisa in combination with VRd followed by Sarclisa-Rd reduced the risk of recurrence or death by 40% versus VRd followed by Rd in transplant-ineligible NDMM patients. The median progression-free survival (PFS) with the Sarclisa-VRd combination was not reached versus 54.3 months with VRd. Additionally, approximately three-quarters (74.7%) of patients treated with Sarclisa-VRd achieved a complete response (CR) compared to 64.1% of patients taking VRd.

The approval of Sarclisa in the EU represents a significant opportunity for Sanofi to tap into the front-line setting for multiple myeloma treatment, which has a substantial unmet need, particularly for transplant-ineligible patients. The EU market for multiple myeloma treatments is substantial, with approximately 48,000 new cases diagnosed each year. The expanded indication could help Sanofi capture a larger share of this market.

However, Sanofi will also face competition from other anti-CD38 therapies, such as daratumumab (Darzalex) and elranatamab (Eliquis), which are already approved for the treatment of multiple myeloma. Additionally, other therapies, such as carfilzomib (Kyprolis) and pomalidomide (Pomalyst), are also used in combination with VRd for the treatment of NDMM. Sanofi will need to differentiate Sarclisa from these competitors to maintain market share and drive revenue growth.

In conclusion, the approval of Sarclisa in the EU represents a significant opportunity for Sanofi to capture a larger share of the multiple myeloma market. The company's commitment to advancing oncology innovation, along with the positive efficacy and safety data from the IMROZ phase 3 study, positions Sarclisa as a strong contender in the treatment of transplant-ineligible NDMM patients. As Sanofi continues to evaluate a subcutaneous administration method for Sarclisa in clinical studies, the potential for improved patient convenience and adherence could further drive market growth.