Sanofi reports positive Phase 3 results for subcutaneous Sarclisa in multiple myeloma

Sanofi has recently announced promising outcomes from a pivotal study focusing on a subcutaneous version of its anti-CD38 therapy, Sarclisa (isatuximab), aimed at treating multiple myeloma (MM) patients. The ongoing IRAKLIA trial has been evaluating a subcutaneous (SC) formulation of Sarclisa, administered at a fixed dose using Enable Injections’s innovative on-body delivery system (OBDS). This method is compared to the traditional weight-based dosing of the drug’s approved intravenous (IV) form in adults with relapsed or refractory MM who have previously undergone at least one treatment line, including therapies like lenalidomide and a proteasome inhibitor.

The study found that combining SC Sarclisa with pomalidomide and dexamethasone (Pd) successfully met its co-primary endpoints. These include achieving a non-inferior objective response rate and maintaining the observed concentration before dosing at steady state, compared to the traditional IV Sarclisa plus Pd treatment. Key secondary goals of the study, such as a very good partial response and a reduced incidence of infusion reactions, were similarly achieved.

Multiple myeloma, the second most prevalent hematological cancer, affects approximately 32,000 individuals in the United States annually. Despite the availability of various treatments, MM remains an incurable condition, with newly diagnosed patients facing a five-year survival rate of about 52%. Sanofi’s Sarclisa, which is already approved in over 50 countries for treating certain cases of relapsed refractory MM, functions by binding to a specific epitope on the CD38 receptor found on MM cells, thereby inducing a unique anti-tumor activity.

Dr. Sikander Ailawadhi, the principal investigator of the IRAKLIA trial from Mayo Clinic Florida, expressed enthusiasm over the findings. He highlighted that the study’s consistent overall response rate, along with the comparable efficacy and safety profile observed for SC Sarclisa, marks a significant advancement. This progress offers a new perspective on a potential administration option for patients. Dr. Ailawadhi emphasized that the results from the trial demonstrate the OBDS's potential to simplify the delivery of this new formulation without compromising patient outcomes.

Houman Ashrafian, Sanofi’s executive vice president and head of research and development, conveyed the company’s eagerness to share the complete results and strive to introduce this innovative advancement to the multiple myeloma community. The announcement comes a little over three months after the U.S. Food and Drug Administration approved the intravenous form of Sarclisa. This approval was for its use in combination with bortezomib, lenalidomide, and dexamethasone to treat newly diagnosed MM patients who are ineligible for autologous stem cell transplants.

In summary, the promising data from the IRAKLIA study could lead to a new method of administering Sarclisa, potentially enhancing the quality of life for multiple myeloma patients by offering a more convenient treatment option without sacrificing efficacy or safety. As the medical community eagerly anticipates further details, Sanofi’s commitment to advancing multiple myeloma treatment remains clear, aiming to provide groundbreaking solutions for this challenging disease.