Janssen has unveiled data from a late-stage trial backing earlier use of its first-in-class biologic daratumumab (marketed as Darzalex) in patients with mutiple myeloma.
Results of the Phase III MAIA study show that adding daratumumab to lenalidomide and dexamethasone cut the risk of disease progression or death in newly diagnosed patients with who are transplant ineligible.
At a median follow-up of 28 months, data daratumumab in combination with dexamethasone significantly reduced the risk of disease progression or death by 44 percent in patients with newly diagnosed multiple myeloma who are transplant ineligible compared to treatment with dexamethasone alone.
The median progression-free survival (PFS) for daratumumab/dexamethasone has not yet been reached, compared to 31.9 months for patients who received the latter alone.
Also, the addition of daratumumab resulted in deeper responses compared to dexamethasone alone, including increased rates of complete response (CR) or better (48 percent versus 25 percent) and improved rates of very good partial response (VGPR) or better (79 percent vs 53 percent).
On the safety side, the most common Grade 3/4 treatment-emergent adverse events for the combination included neutropenia (50 percent), lymphopenia (15 percent), pneumonia (14 percent) and anaemia (12 percent).
Treatment-emergent adverse event with an outcome of death were 7 percent in the daratumumab/dexamethasone arm compared to 6 percent in the dexamethasone arm.
Thierry Facon, Service des Maladies du Sang, Hôpital Claude Huriez, Lille, France, said the 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.
“The positive data show the potential role of daratumumab in combination with lenalidomide and dexamethasone as an important new therapeutic approach for this patient population.”
Janssen said the data will support a future marketing application for daratumumab in combination with dexamethasone for this patient population.
In Europe, the drug is already approved for use: in combination with bortezomib, melphalan and prednisone for the treatment of adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; as monotherapy for the treatment of adults with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy; and in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.