As reported in the Journal of Clinical Oncology by Mai et al, the German phase III GMMG-HD7 trial (Part 1) showed that the addition of isatuximab (Isa) to standard-of-care lenalidomide/bortezomib/dexamethasone (RVd) improved progression-free survival irrespective of maintenance therapy strategy in transplant-eligible patients with newly diagnosed multiple myeloma.
Study Details
In the multicenter open-label trial, 660 eligible patients were randomly assigned between October 2018 and September 2020 to receive induction therapy with Isa/RVd (n = 331) or RVd (n = 329) followed by single or tandem autologous stem-cell transplantation and second random assignment to maintenance with lenalidomide alone or isatuximab/lenalidomide. The initial report from the trial showed that Isa/RVd was associated with a significantly higher minimal residual disease (MRD)-negative rate after induction.
Key Findings
Updated results from first random assignment to posttransplantation showed that, as of the end of January 2024, MRD-negative rates continued to favor Isa/RVd vs RVd (66% vs 48%). Isa/RVd induction significantly prolonged progression-free survival vs RVd regardless of maintenance therapy used (hazard ratio = 0.70, 95% confidence interval [CI] = 0.52–0.95, P = .0184).
A significant progression-free survival benefit was observed for Isa/RVd followed by lenalidomide maintenance vs RVd followed by lenalidomide maintenance (P = .016).
The investigators concluded: “…[A]fter 18-week induction therapy followed by transplant without consolidation therapy, adding Isa to RVd resulted in a significant [progression-free survival] benefit, regardless of maintenance strategy.”
Hartmut Goldschmidt, MD, Heidelberg Myeloma Center, Heidelberg University, is the corresponding author for the Journal of Clinical Oncology article.
Disclosures: The trial was funded by Sanofi. For full disclosures of all study authors, visit the Journal of Clinical Oncology.
