Sarclisa Induction Treatment Improves Progression-Free Survival in Transplant-Eligible Multiple Myeloma Patients

Sarclisa Induction Therapy Significantly Improves Progression-Free Survival in Newly Diagnosed Multiple Myeloma Patients Eligible for Transplant

Sarclisa (isatuximab) combined with standard treatments lenalidomide, bortezomib, and dexamethasone (RVd) during an 18-week induction period followed by a transplant has shown a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for patients newly diagnosed with multiple myeloma (NDMM) who are eligible for transplant. This finding holds irrespective of the subsequent maintenance therapy used.

The GMMG-HD7 study, one of six phase 3 trials showing positive results for Sarclisa in multiple myeloma (MM), highlights its potential as a foundational therapy when added to the current standard of care for various MM patient populations. 

New data from the GMMG-HD7 phase 3 study, conducted by the German-speaking Myeloma Multicenter Group (GMMG), indicates that Sarclisa combined with RVd significantly prolongs PFS from the first randomization. This results in a notable reduction in disease progression or death compared to RVd alone, regardless of the maintenance regimen used. Comprehensive results will be presented at an upcoming medical conference.

Hartmut Goldschmidt, MD, the study's principal investigator and a professor at Heidelberg University Hospital, emphasized the critical role of effective induction therapy in reducing relapse risk in newly diagnosed multiple myeloma patients. He noted that while improved minimal residual disease (MRD) negativity rates were observed in the bone marrow, indicating deeper responses after induction, further follow-up was necessary to understand long-term outcomes. The new data suggest that the Isa-RVd combination may improve PFS in the frontline, transplant-eligible patient population, supporting its potential as a new standard-of-care induction regimen.

The GMMG-HD7 trial is part of a broader research effort, including the IMROZ phase 3 study, which evaluated Sarclisa with VRd in transplant-ineligible NDMM patients, also demonstrating significant improvements in PFS and higher MRD negativity rates.

Dietmar Berger, MD, PhD, Chief Medical Officer and Global Head of Development at Sanofi, explained that the GMMG-HD7 study was designed to explore the specific impact of targeting CD38 with Sarclisa in induction versus maintenance treatment for transplant-eligible patients. The data reinforce Sarclisa's potential to become a best-in-class CD38 therapy, improving long-term outcomes compared to current standards.

In December 2021, Sanofi and GMMG shared results from the first part of the study, which met the primary endpoint of MRD negativity after induction therapy and before transplant in NDMM patients. The study, designed and conducted in collaboration with Sanofi, involved financial support from Sanofi. The use of Sarclisa in combination with RVd is still investigational and has not yet been evaluated by any regulatory authority.

Multiple myeloma, a rare but the second most common hematologic cancer, affects over 180,000 new patients globally each year. Despite available treatments, it remains largely incurable, with most patients experiencing relapse or becoming refractory to therapy. 

The GMMG-HD7 study involved 662 transplant-eligible NDMM patients across 67 German sites. Participants were randomized to receive three 42-day cycles of RVd, with Sarclisa added to one study arm. Following transplant, participants were re-randomized to either Sarclisa plus lenalidomide or lenalidomide alone as maintenance therapy. 

Sarclisa, a monoclonal antibody targeting the CD38 receptor on MM cells, is designed to induce antitumor activity through multiple mechanisms, including apoptosis and immunomodulation. It is approved in over 50 countries for various MM treatments, and its potential continues to be explored in ongoing phase 3 clinical studies.

The German-speaking Myeloma Multicenter Group (GMMG) has been pivotal in advancing MM research in Germany, conducting numerous studies over the past 20 years, and aims to develop improved therapies through novel treatment strategies.

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