Post-intensification data confirm superiority of quadruple therapy in MM

An interim analysis of the phase 3 GMMG-HD7 study showed that the addition of isatuximab to lenalidomide, bortezomib, and dexamethasone (VRd) ameliorated clinical remission and MRD negativity rates after intensification by high-dose therapy (HDT) and allogeneic stem cell transplantation (allo-SCT) in transplant-eligible participants with previously untreated multiple myeloma (MM).

The phase 3 GMMG-HD7 trial (NCT03617731) previously demonstrated that the anti-CD38 monoclonal antibody isatuximab plus VRd is more successful in inducing MRD negativity than VRd alone in transplant-eligible participants with newly diagnosed MM (50.1% vs 35.6%; P<0.001; n=660) [1]. The current interim analysis, presented by Prof. Marc Raab (University Hospital Heidelberg, Germany), looked at MRD negativity rates after intensification [2].

At least 1 intensification was administered to 598 participants and 179 received a second intensification. Clinical remission rates (43.5% vs 34.0%; P=0.013), and partial response rates (82.8% vs 68.7%; P<0.0001) after intensification were significantly higher in the isatuximab arm. Similarly, more participants achieved MRD negativity (10^-5) after intensification in the isatuximab arm than in the VRd alone arm (66.2% vs 47.7%; OR 2.13; 95% CI 1.56–2.92). Finally, 52.8% and 36.8% of the participants converted from MRD positive after induction to MRD negative after intensification in the isatuximab and VRd arms, respectively.

Isatuximab plus VRd improved MRD negativity and clinical remission rates after intensification as compared with VRd alone in transplant-eligible newly diagnosed participants with MM. The trial is ongoing and will investigate the role of isatuximab in combination with lenalidomide as maintenance therapy after a second randomisation.

1. Goldschmidt H, et al. Lancet Haematol. 2022;9(11):e810–821.
2. Raab MS, et al. Isatuximab, lenalidomide, bortezomib, and dexamethasone for newly diagnosed, transplant-eligible multiple myeloma: post-transplantation interim analysis of the randomized phase 3 GMMG-HD7 trial. S202, EHA congress 2024, 13–16 June, Madrid, Spain.

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Posted on 12 August 2024