Janssen presents strong Phase 3 showing for Darzalex in multiple myeloma subgroup
pharmafile | May 30, 2019 | News story | Research and Development | Janssen, darzalex, pharma
Janssen has lifted the curtain on new Phase 3 data for Darzalex (daratumumab) in combination with lenalidomide and dexamethasone (Rd), showing that the combo demonstrated a “significant increase in progression-free survival (PFS)” in the treatment of newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation (ASCT).
After a median follow-up period of 28 months, the Darzalex/Rd combo demonstrated a reduction of 44% in the risk of disease progression or death, while median PFS was not reached, compared to 31.9 months with Rd alone. Overall response rate (ORR) for the Darzalex combo stood at 92.9% compared to 81.3%, while the combo almost doubled complete response rates compared to Rd, scoring 47.6% and 24.9% respectively.
Additionally, the combo was found to more than triple the rate of minimal residual disease negativity, scoring 24.2% compared to 7.3% with Rd alone, while all patients with such status achieved a complete response or better.
“We continue to see scientific evidence through Phase 3 studies that support the use of daratumumab in combination with standard of care regimens,” said Dr Thierry Facon, Service des Maladies du Sang, Hôpital Claude Huriez in France, as well as investigator and author of the study. “As multiple myeloma can become more complex at each relapse, it is important to select an optimal upfront therapy. Results from the MAIA study suggest that this daratumumab combination therapy should be considered for patients with multiple myeloma who are transplant ineligible upon diagnosis.”
Dr Craig Tendler, Vice President, Clinical Development and Global Medical Affairs, Oncology at Janssen, also remarked: “The MAIA study findings demonstrate a consistent and clinically meaningful treatment effect when Darzalex is incorporated into standard backbone regimens, such as lenalidomide and dexamethasone, for the initial treatment of patients with multiple myeloma who are transplant ineligible. We have submitted applications to global health authorities in support of the MAIA data and look forward to working with regulators in the hope of bringing a new combination regimen to patients diagnosed with multiple myeloma.”
Matt Fellows
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