StemCell Therapy

Denmark-based Genmab A/S announced positive topline data from the second part of the Phase III CASSIOPEIA trial. The study is evaluating daratumumab monotherapy as maintenance treatment compared to observation, in other words, no treatment, for patients with newly diagnosed multiple myeloma that are eligible for autologous stem cell transplant (ASCT).

The second part of the trial is being conducted by the French Intergroupe Francophone du Myelome (IFM) in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and Janssen Research & Development, a Johnson & Johnson company.

The trials primary endpoint was improved progression free survival (PFS), which the trial met at a pre-planned interim analysis. It demonstrated a 47% decrease in the risk of progression or death in the patients receiving daratumumab. The safety profile was consistent with previous studies and no new safety signals were seen.

An Independent Data Monitoring Committee (IDMC) has recommended the study results be unblinded. Janssen Biotech licensed the drug from Genmab in 2012 and indicates it plans to meet with regulators to discuss a possible submission for this indication. It also plans to present the data at an upcoming medical conference and submit it for a peer-reviewed scientific journal.

Following the positive data from the first part of the CASSIOPEIA study, we are very pleased to see this benefit, said Jan van de Winkel, chief executive officer of Genmab. We are appreciative of the efforts of the IFM, of HOVON and of Janssen for their work on this study.

Darzalex (daratumumab) is indicated for treatment of adults in the U.S. in combination with carfilzomib and dexamethasone for relapsed/refractory multiple myeloma patients who have received one to three earlier lines of therapy; in combination with bortezomib, thalidomide and dexamethasone for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant, and for several other combinations and as a monotherapy for various stages of multiple myeloma.

The drug is a human IgG1k monoclonal antibody. It binds strongly to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. The drug causes an individuals own immune system to attack the cancer cells, causing rapid tumor cell death via multiple immune-mediated mechanisms of action and through immunomodulatory effects, as well as direct tumor cell death by way of apoptosis.

Net sales of Darzalex in the first quarter of 2020 totaled $937 million, with $463 million in the U.S. and $474 in the rest of the world.

The CASSIOPEIA Phase III trial included 1,085 newly diagnosed patients with previously untreated symptomatic multiple myeloma who were eligible for high-dose chemotherapy and ASCT. In the first part of the trial, patients received induction and consolidation treatment with daratumumab combined with bortezomib, thalidomide and dexamethasone (VTd) or VTd alone. The primary endpoint was the number of patients that achieved a stringent complete response (sCR).

In the second part of the study, which is what is being reported on today, patients that achieved a response in the first part underwent a second randomization to receive either maintenance treatment of 1i6 mg/kg every eight weeks for up to two years of daratumumab, or no further treatment. The primary endpoint was progression-free survival.

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J&J's Darzalex Proves Effective in Yet Another Multiple Myeloma Indication - BioSpace

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