Recent results from the GMMG-HD7 phase 3 study, a two-part, double-randomized trial by the German-speaking Myeloma Multicenter Group, indicate that Sarclisa (isatuximab), when combined with lenalidomide, bortezomib, and dexamethasone (RVd) for induction therapy, significantly enhances progression-free survival (PFS) in transplant-eligible patients with newly diagnosed multiple myeloma (NDMM). Sanofi (SNYNF, SNY), the French pharmaceutical giant, announced this in a recent statement.
The company highlighted that this combination therapy leads to a statistically significant and clinically meaningful reduction in disease progression or death compared to RVd induction alone, regardless of the subsequent maintenance regimen. Detailed findings of the study will be presented at an upcoming medical conference.
The GMMG-HD7 study is part of six phase 3 trials reporting positive outcomes for Sarclisa in multiple myeloma patients, including four successful readouts for a Sarclisa-based quadruplet in first-line treatment settings. Notably, the IMROZ phase 3 study showcased Sarclisa with VRd versus VRd alone in transplant-ineligible NDMM patients, demonstrating a statistically significant and clinically meaningful improvement in PFS, along with a higher percentage of patients achieving minimal residual disease (MRD) negativity.
