Sanofi has shared promising results from a late-stage study of Sarclisa (isatuximab) as an induction therapy for patients with newly diagnosed multiple myeloma (MM) who are eligible for transplant.
The two-part German-speaking Myeloma Multicenter Group (GMMG)-HD7 trial has been evaluating the anti-CD38 monoclonal antibody, administered as an intravenous infusion, in combination with standard-of-care lenalidomide, bortezomib and dexamethasone (RVd) versus RVd induction.
MM is the second most common haematological malignancy, with more than 180,000 new cases diagnosed globally every year. Despite available treatments, the disease remains incurable and newly diagnosed patients have a five-year survival rate of about 61%.
Sanofi’s Sarclisa, which already holds approvals to treat certain patients with relapsed refractory MM and previously treated MM, is designed to bind to a specific epitope on the CD38 receptor on MM cells and induce distinct anti-tumour activity.
The Sarclisa/RVd induction therapy demonstrated a statistically significant and clinically meaningful reduction in disease progression or death compared to RVd, regardless of maintenance regimen.
The combination was also associated with improved minimal residual disease negativity rates in the bone marrow. Principal study investigator Hartmut Goldschmidt said this indicates “potentially deeper responses after induction”, but noted that further follow-up is needed to better understand how this translates to long-term outcomes.
Goldschmidt, president of GMMG and professor of medicine at the Heidelberg University Hospital, said: “Successful induction therapy is one of the most critical components to reduce the relapse or recurrence risk in patients with newly diagnosed MM… 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 second part of the study is evaluating Sarclisa plus lenalidomide versus lenalidomide alone as a post-transplant maintenance therapy.
The results come just two months after Sanofi announced positive data from a phase 3 trial assessing Sarclisa plus VRd, followed by Sarclisa-Rd, in newly diagnosed MM patients who are not eligible for transplant.
The results, presented at this year’s American Society of Clinical Oncology Annual Meeting, demonstrated a 40% reduction in the risk of disease progression or death in patients treated with the Sarclisa/VRd regimen compared to VRd alone.