On April 28, 2017 Genmab A/S (OMX: GEN) reported that Janssen Research & Development, LLC, in collaboration with the European Myeloma Network (EMN) and Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON), plans to start a Phase III study of daratumumab in relapsed and refractory multiple myeloma (Press release, Genmab, APR 28, 2017, View Source [SID1234518723]). The study (MMY3013, APOLLO) is a randomized Phase III that will compare daratumumab in combination with pomalidomide and dexamethasone versus pomalidomide and dexamethasone in patients who have previously been treated with an immunomodulatory drug and a proteasome inhibitor (PI). The study is expected to start in Q2 2017 and is designed to confirm results from the MMY1001 (EQUULEUS) study, a Phase I study investigating the daratumumab-pomalidomide-dexamethasone combination, are currently under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) date of June 17, 2017.
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"We are very pleased to see this Phase III study initiated. The combination of daratumumab with pomalidomide and dexamethasone may represent a new approach for patients who have been previously treated with an immunomodulatory drug and a PI. We look forward to the readout of this study," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
About the MMY3013 (APOLLO) study
This is a Phase III, randomized, open-label, multicenter study and will include approximately 354 patients with multiple myeloma who have previously been treated with an immunomodulatory drug and a PI. Patients will be randomized 1:1 to either receive daratumumab in combination with pomalidomide and dexamethasone or pomalidomide and dexamethasone alone. The primary endpoint of the study is progression-free survival (PFS). The study will be conducted in Europe by the European Myeloma Network in collaboration with Janssen.
About DARZALEX (daratumumab)
DARZALEX (daratumumab) injection for intravenous infusion is indicated in the United States in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.1 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (FDA) approval to treat multiple myeloma. DARZALEX is indicated in Europe 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 and for use as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. For more information, visit www.DARZALEX.com .
Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).1,2,3,4,5
Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. Five Phase III clinical studies with daratumumab in relapsed and frontline multiple myeloma settings are currently ongoing, and additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant diseases on which CD38 is expressed, such as smoldering myeloma, NK/T-cell lymphoma, amyloidosis, myelodysplastic syndromes and solid tumors. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA, for multiple myeloma, as both a monotherapy and in combination with other therapies.