Sanofi shares positive phase 3 results for Sarclisa in new multiple myeloma cases

Sanofi has reported favorable outcomes from a late-stage trial investigating Sarclisa (isatuximab) as an induction therapy for newly diagnosed multiple myeloma (MM) patients eligible for transplant. This study, known as the GMMG-HD7 trial, conducted by the German-speaking Myeloma Multicenter Group, evaluates Sarclisa in combination with lenalidomide, bortezomib, and dexamethasone (RVd) against the standard RVd regimen.

MM, the second most prevalent hematological malignancy, sees over 180,000 new cases globally each year. Despite existing treatments, the condition remains incurable, with a five-year survival rate of approximately 61% for newly diagnosed patients. Sanofi's Sarclisa, already approved for certain relapsed refractory MM and previously treated MM cases, is engineered to bind to a specific CD38 receptor epitope on MM cells, promoting anti-tumor activity.

The GMMG-HD7 trial revealed that the Sarclisa/RVd induction therapy significantly reduced disease progression or death compared to RVd alone, irrespective of maintenance therapy. Additionally, the combination therapy improved minimal residual disease negativity rates in bone marrow. According to Principal Investigator Hartmut Goldschmidt, this suggests “potentially deeper responses after induction," although more follow-up is required to ascertain the long-term implications.

Goldschmidt, who is also the president of GMMG and a professor of medicine at Heidelberg University Hospital, emphasized the importance of successful induction therapy in reducing relapse or recurrence risks in newly diagnosed MM patients. He stated, “This data provides evidence that the Sarclisa/RVd regimen potentially improves progression-free survival in the frontline, transplant-eligible population and supports the potential of this quadruplet to become a new standard-of-care induction regimen in this treatment setting.”

The trial's second phase is focusing on Sarclisa combined with lenalidomide versus lenalidomide alone for post-transplant maintenance therapy. These promising results follow Sanofi’s recent announcement of positive data from a phase 3 trial assessing Sarclisa plus VRd, followed by Sarclisa-Rd, for newly diagnosed MM patients who are not transplant-eligible. Presented at this year’s American Society of Clinical Oncology Annual Meeting, the trial demonstrated a 40% reduction in the risk of disease progression or death in patients treated with the Sarclisa/VRd regimen compared to VRd alone.