Phase III APOLLO study of Darzalex + Pomalyst + dexamethasone meets primary endpoint in multiple myeloma.- Janssen Biotech

The European Myeloma Network in collaboration with Janssen Research & Development reported positive results from the Phase III APOLLO (MMY3013) study of the subcutaneous (SC) formulation of Darzalex (daratumumab) in combination with Pomalyst (pomalidomide) and dexamethasone (Pd) versus Pd alone as treatment for patients with relapsed or refractory multiple myeloma who have previously been treated with lenalidomide (an immunomodulatory drug) and a proteasome inhibitor (PI). The study met the primary endpoint of improving progression-free survival (PFS). Overall, the safety profile of daratumumab SC in combination with Pd was consistent with the safety profile for each therapy separately. Janssen Biotech intends to discuss the data with health authorities in preparation for regulatory submissions and plans to submit the data for presentation at an upcoming medical conference.The APOLLO study was designed to confirm the results from the Phase I EQUULEUS (MMY1001) study, which investigated intravenous (IV) daratumumab plus Pd in the same indication. In June 2017, the U.S. Food and Drug Administration (U.S. FDA) approved the use of Darzalex in combination with Pd for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a PI based on the results of the EQUULEUS study. Janssen Biotech obtained an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab in 2012.