Sarclisa (isatuximab) combined with the standard treatment regimen of lenalidomide, bortezomib, and dexamethasone (RVd) over an 18-week induction period, followed by a transplant, has demonstrated a significant and clinically important enhancement in progression-free survival (PFS) for patients with newly diagnosed multiple myeloma who are eligible for transplant. This benefit was observed irrespective of the maintenance therapy used, showcasing the potential of Sarclisa when included in the induction treatment for newly diagnosed multiple myeloma (NDMM) patients undergoing transplant.
The GMMG-HD7 study is a crucial phase 3 trial that has yielded positive outcomes for Sarclisa in multiple myeloma, adding to four other successful studies that have supported the use of a Sarclisa-based quadruplet therapy in the initial treatment of this condition. These results emphasize the promise of Sarclisa as a fundamental component in the treatment regimen for multiple myeloma across various patient demographics.
New findings from the GMMG-HD7 phase 3 study, conducted by the German-speaking Myeloma Multicenter Group (GMMG), revealed that the addition of Sarclisa to the RVd regimen during induction therapy significantly extended PFS from the time of first randomization. This translated into a noteworthy and clinically relevant reduction in the risk of disease progression or death when compared to RVd alone, irrespective of the post-transplant maintenance therapy employed.
The GMMG-HD7 is among six pivotal phase 3 trials that have demonstrated positive outcomes for Sarclisa in multiple myeloma patients, including four successful trials evaluating Sarclisa-based quadruplet therapy in the frontline setting. Notably, the IMROZ phase 3 study also showed significant PFS improvement and a higher rate of minimal residual disease (MRD) negativity when Sarclisa was combined with VRd in patients with transplant-ineligible NDMM.
In December 2021, Sanofi and GMMG shared early results from the study's first phase, which met the primary endpoint of achieving MRD negativity after induction therapy and before transplant in NDMM patients. The study, initiated by GMMG in close collaboration with Sanofi, was financially supported by Sanofi.
It is important to note that the use of Sarclisa in combination with RVd is still investigational and has not received regulatory approval.
Multiple myeloma, while considered a rare condition, is the second most common blood cancer, with over 180,000 new cases diagnosed globally each year. Despite available treatments, the disease remains incurable for most patients, with an estimated 61% five-year survival rate for newly diagnosed individuals. Relapsed multiple myeloma refers to the return of the cancer after treatment or remission, while refractory multiple myeloma describes cases where the cancer does not respond or stops responding to therapy.
About the GMMG-HD7 Study
The GMMG-HD7 trial is a pivotal, randomized, open-label, multicenter phase 3 study evaluating the effectiveness of Sarclisa in combination with RVd during induction therapy, followed by re-randomization to Sarclisa plus lenalidomide versus lenalidomide alone for maintenance post-transplant in transplant-eligible NDMM patients. The study enrolled 662 participants across 67 sites in Germany. In the first part, patients were equally randomized to receive three 42-day cycles of RVd, with Sarclisa added to one arm. In the second part, patients were re-randomized post-transplant to receive either Sarclisa with lenalidomide or lenalidomide alone as maintenance therapy.
MRD negativity was evaluated using next-generation flow cytometry following induction. The latest results measured PFS for both the Sarclisa plus RVd induction therapy and the Sarclisa plus lenalidomide maintenance therapy from the first randomization point.
The primary endpoint for the study's first phase was MRD negativity after induction treatment, with PFS following the second randomization as the primary endpoint for the second phase. Key secondary endpoints included complete response rates post-induction, overall survival, and safety.
About Sarclisa
Sarclisa (isatuximab) is a monoclonal antibody that targets the CD38 receptor on multiple myeloma cells, promoting tumor cell death and modifying immune responses. CD38 is a protein commonly found on the surface of multiple myeloma cells, making it a prime target for antibody-based treatments like Sarclisa.
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