Author: By Laura Cowen, medwireNews Reporter
medwireNews: Adding the anti-CD38 monoclonal antibody isatuximab to standard induction therapy with lenalidomide plus bortezomib and dexamethasone (RVd) significantly increases the rate of minimal residual disease (MRD) negativity in patients with transplant-eligible, newly diagnosed multiple myeloma (MM), phase III study findings indicate.
Speaking at the 63rd American Society of Hematology Annual Meeting & Exposition in Atlanta, Georgia, USA, Hartmut Goldschmidt, from University Hospital Heidelberg in Germany, said that 35.6% of 329 patients who were randomly assigned to receive three 42-day cycles of induction therapy with RVd were MRD negative at the end of this treatment period. MRD was assessed by next-generation flow with a cutoff of 1 x 10-5 for negativity.
By comparison, the MRD negativity rate was significantly higher, at 50.1%, in the 331 patients given RVd plus isatuximab, corresponding to a significant 1.83-fold increased likelihood of achieving MRD negativity with the monoclonal antibody.
Hartmut Goldschmidt noted that this rate was “the highest described to date in a randomized trial setting.”
All participants in the GMMG-HD7 study, who were recruited from 67 sites across Germany, received lenalidomide 25 mg/day on days 1–14 and 22–35, bortezomib 1.3 mg/m2 on days 1, 4, 8, 11, 22, 25, 29 and 32, and dexamethasone 20 mg/day on days 1–2, 4–5, 8–9, 11–12, 15, 22–23, 25–26, 29–30 and 32–33. Those in the isatuximab arm also received isatuximab 10 mg/kg on days 1, 8, 15, 22 and 29 of cycle 1 and on days 1, 15 and 29 of cycles 2 and 3.
The presenter also reported that adding isatuximab to RVd “had no significant impact on the safety profile or dose intensity of RVd.”
Overall, 61.3% of participants who received RVd and 63.6% of those who received RVd plus isatuximab experienced at least one adverse event (AE) of grade 3 or worse during induction. Serious AEs occurred in a respective 36.3% and 34.8%. There were eight deaths in the RVd group during induction and four in the RVd plus isatuximab group.
The rate of leukocytopenia or neutropenia was 9.1% in the group that did not receive isatuximab and 26.4% in the group that did, but Hartmut Goldschmidt noted pointed out that this did not translate to a higher rate of infections with isatuximab.
Hartmut Goldschmidt concluded: “Addition of isatuximab to RVd induction improved rates of MRD negativity and should be considered a new standard of care in transplant-eligible, newly-diagnosed multiple myeloma patients.”
He added that the GMMG-HD7 trial is ongoing and will include post-autologous transplantation analyses, and a second randomisation to evaluate the efficacy of the addition of isatuximab to lenalidomide maintenance.
Goldschmidt H, Mai EK, Nievergall E, et al. Addition of Isatuximab to Lenalidomide, Bortezomib and Dexamethasone As Induction Therapy for Newly-Diagnosed, Transplant-Eligible Multiple Myeloma Patients: The Phase III GMMG-HD7 Trial. Abstract 463; 63rd American Society of Hematology Annual Meeting & Exposition; Atlanta, Georgia, USA: 11–14 December 2021
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