Johnson & Johnson’s (J&J) Darzalex (daratumumab), in combination with lenalidomide and dexamethasone (Rd), has significantly reduced the risk of disease progression in multiple myeloma study.
The phase 3 MAIA study showed that the daratumumab, in combination with lenalidomide and dexamethasone (Rd), has reduced the risk of disease progression or death in patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
The trial principal investigator Dr Thierry Facon said: “The Phase 3 MAIA study reinforces the clinical profile of daratumumab in combination with a standard of care treatment regimen for newly diagnosed patients with multiple myeloma who are transplant ineligible.”
MAIA is a randomised, open-label and multicentre phase 3 study that recruited 737 newly diagnosed patients with multiple myeloma ineligible for high-dose chemotherapy and ASCT aged 45-90 years old.
Daratumumab is a first-in-class biologic targeting CD38, a surface protein that is eminently expressed across multiple myeloma cells, irrespective of disease stage.
Daratumumab is supposed to induce tumour cell death via multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).
In addition, daratumumab is being studied in a comprehensive clinical development program across different treatment settings in multiple myeloma.
In Europe, daratumumab is indicated for use in combination with bortezomib, melphalan and prednisone to treat adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant and as monotherapy to treat adult patients with relapsed and refractory multiple myeloma.
Daratumumab, in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, is indicated to treat adult patients with multiple myeloma who have received at least one prior therapy.
In August 2012, Janssen Biotech entered into a worldwide agreement with Genmab, under which Janssen secured an exclusive license to develop, manufacture and commercialise daratumumab.
Janssen-Cilag Europe, Middle East and Africa (EMEA) Hematology therapy area lead Dr Catherine Taylor said: “These data underscore the consistent clinical profile observed among newly diagnosed patients with multiple myeloma receiving daratumumab therapy, including for those who are transplant ineligible.”