Darzalex Phase 3 Study Shows Efficacy and Safety Data of Anti-CD38 Monoclonal Antibody in Patients with Newly Diagnosed Multiple Myeloma

The Janssen Pharmaceutical Companies of Johnson & Johnson announced results from the Phase 3 MAIA study demonstrating that the addition of daratumumab to lenalidomide and dexamethasone (Rd) significantly reduced the risk of disease progression or death in patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT) (Abstract #LBA-2).1 These data were featured during the late-breaking abstract (LBA) oral session at the 60th American Society of Hematology (ASH) Annual Meeting in San Diego, CA.

"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," said Thierry Facon, M.D., Service des Maladies du Sang, Hôpital Claude Huriez, Lille, France, and principal investigator. "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."

At a median follow-up of 28 months, data from the Phase 3 MAIA study showed daratumumab in combination with Rd 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 Rd alone (Hazard Ratio [HR] = 0.56; 95 percent confidence interval [CI]: 0.43-0.73; p<0.0001).1 The median progression-free survival (PFS) for daratumumab-Rd has not yet been reached, compared to 31.9 months for patients who received Rd alone.1 The addition of daratumumab resulted in deeper responses compared to Rd alone, including increased rates of complete response (CR) or better (48 percent vs. 25 percent) and improved rates of very good partial response (VGPR) or better (79 percent vs. 53 percent).1 Daratumumab-Rd induced a >3-fold higher rate of minimal residual disease (MRD) negativity compared to those who received Rd alone (24 percent vs. 7 percent).1

"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," said Dr Catherine Taylor, Haematology Therapy Area Lead, Europe, Middle East and Africa (EMEA), Janssen-Cilag Limited. "This is the third study in newly diagnosed patients that has met its primary endpoint and we hope to continue delivering innovative advances to patients with multiple myeloma through our robust clinical research programme, which has the potential to revolutionise cancer treatment by arresting the disease at its earliest stages."

The most common Grade 3/4 treatment-emergent adverse events (TEAEs) for daratumumab-Rd (≥10 percent) included neutropenia (50 percent), lymphopenia (15 percent), pneumonia (14 percent) and anaemia (12 percent).1 Infusion-related reactions (IRRs) occurred in 41 percent of patients, only 3 percent of which were Grade 3/4. Incidence of invasive second primary malignancy was 3 percent in the daratumumab-Rd arm compared to 4 percent with Rd alone.1 TEAEs with an outcome of death were 7 percent in the daratumumab-Rd arm compared to 6 percent in the Rd arm.1 The safety profile of daratumumab was consistent with that of previous studies.1

These data will support a future application for marketing authorisation for daratumumab in combination with Rd for this patient population.

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