Janssen presents positive Darzalex results at ASCO
Janssen Oncology has announced key data on Darzalex (daratumumab) for multiple myeloma at this year’s American Society of Clinical Oncology (ASCO) annual meeting in Chicago.
In a Phase III CASSIOPEIA (MMY3006, NCT02541383) study, the addition of the drug was found to result in higher response rates and longer progression-free survival (PFS) than bortezomib, thalidomide and dexamethasone (VTd) alone in patients with newly diagnosed multiple myeloma.
The stringent complete response rate was significantly higher in the Darzalex and VTd arm – 29% - compared to VTd alone – 20%. Also, at a median follow-up of 18.8 months, PFS was significantly improved in the Darzalex group.
CASSIOPEIA is the “first study to investigate the clinical benefit of Darzalex in combination with a standard of care treatment regimen in patients with newly diagnosed multiple myeloma undergoing autologous stem cell transplant,” said Dr Philippe Moreau, CASSIOPEIA primary investigator and head of the Hematology Department at the University Hospital of Nantes, France.
He continued, “There is a need for new treatment options for newly diagnosed patients, potentially including this combination therapy with daratumumab. This study adds to the growing body of evidence for daratumumab in the frontline setting.”
Another trial, the Phase III COLUMBA (MMY3012, NCT03277105) study, a subcutaneously (SC) administered formulation of Darzalex formulated with recombinant human hyaluronidase PH20 (rHuPH20) showed non-inferior efficacy and pharmacokinetics for the SC administered formulation of daratumumab compared to intravenous (IV) administration.
The study “showed that the subcutaneous formulation of daratumumab resulted in non-inferior pharmacokinetics and efficacy compared to the current intravenous formulation, and also importantly offers the potential for a fixed-dose administration, shorter infusion times and a lower rate of infusion-related reactions,” said Maria-Victoria Mateos, COLUMBA primary investigator and director of the Myeloma Unit at University Hospital of Salamanca-IBSAL, Salamanca, Spain.
She continued, “Daratumumab IV has proven to be an important medication in the treatment of multiple myeloma, and a new subcutaneous formulation may offer patients a different experience, including a shorter administration time.”
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterised by an excessive proliferation of plasma cells. In Europe, more than 48,200 people were diagnosed with multiple myeloma in 2018, and more than 30,800 patients died. Almost 40% of patients with multiple myeloma do not reach five-year survival.
3rd June 2019http://www.pharmatimes.com/