Darzalex ®▼(daratumumab) in Combination with Lenalidomide and Dexamethasone approved for reimbursement in Ireland for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible

Janssen, the Pharmaceutical Companies of Johnson & Johnson, announced today that Darzalex ^®(daratumumab) in combination with lenalidomide and dexamethasone (DRd) has been reimbursed in Ireland for the treatment of newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant (ASCT). Since launch, daratumumab has been used to treat more than 484,000 patients worldwide.²

• Combination regimen reduces the risk of disease progression or death by 44 percent in newly diagnosed patients who are transplant ineligible¹

The approval follows results from the Phase 3 MAIA (MMY3008) study, published in The New England Journal of Medicine ³ in 2019 and presented at the American Society of Hematology (ASH) Annual Meeting in 2018, with updated efficacy data in 2022.⁴ 

Professor Michael O’Dwyer, Professor of Haematology, Consultant Haematologist and HRB Clinician Scientist, NUI Galway said: “Multiple myeloma is a very diverse disease and there is increasing evidence pointing to the need for tailored treatment, meaning we cannot treat all patients the same way. Typically, it becomes more difficult to treat this condition following relapse. Improving the treatment response upfront is critical. It was a privilege to be part of the MAIA study as principal investigator in Ireland and witnessing firsthand the impact this treatment can bring to patients’ lives. Patients who are ineligible for transplant have a limited range of frontline therapeutic options available to them, so the availability of this regimen represents an important advance for treating multiple myeloma in Irish patients.”

The MAIA study included 737 newly diagnosed patients with multiple myeloma ineligible for high-dose chemotherapy and ASCT aged 45-90 years old (median age of 73 years).¹ 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  In the interim analysis of the MAIA study at median follow-up of 28.0 months, the median progression-free survival (PFS) for daratumumab-Rd had not yet been reached, compared to 31.9 months for patients who received Rd alone.¹ At a median follow-up of 64.5 months, progression-free survival (PFS) was improved with daratumumab-Rd  (61.9 months) versus Rd alone (34.4 months).⁴ After a median follow-up of 73.6 months, the addition of daratumumab to Rd reduced the risk of death by 35%, in comparison to Rd.⁴ The addition of daratumumab resulted in deeper responses compared to Rd alone, including increased rates of complete response (CR) or better (51.1 percent vs. 30.1 percent) and improved rates of very good partial response (VGPR) or better (81.5 percent vs. 56.9 percent).⁴ Daratumumab-Rd induced a nearly >3-fold higher rate of minimal residual disease (MRD) negativity compared to those who received Rd alone (32.1 percent vs. 11.1 percent).⁴ 

Dr Bríd Seoighe, Medical Director, Commercial Business at Janssen Sciences Ireland UC, said: “Around 380 people are diagnosed with multiple myeloma each year in Ireland. Reimbursement of the DRd regimen is a positive step in expanding the range of therapeutic options with the potential to evoke deeper responses in Irish patients with advanced multiple myeloma. Spanning more than two decades of research and development in treating multiple myeloma, Janssen is committed to delivering more treatment options tailored to patients’ individual needs.”

The most common Grade 3/4 treatment-emergent adverse events (TEAEs) for daratumumab-Rd included neutropenia (54.1 percent), pneumonia (19.5 percent) and anaemia (17 percent).⁴ The rate of treatment discontinuation due to TEAEs was lower in the D-Rd arm (14.6 percent) versus the Rd arm (23.8 percent).⁴ In Europe, daratumumab is indicated:⁵

• in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant,
• in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant,
• 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,
• in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide-refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy
• as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor (PI) and an immunomodulatory agent, and who have demonstrated disease progression on the last therapy. 

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