Daratumumab could make its way to newly diagnosed myeloma patients, based on results from the second part of the Phase III CASSIOPEIA study. This is a study that includes 1085 newly diagnosed, transplant eligible patients using daratumumab as induction with bortezomib, thalidomide and dex (VTd) or VTd alone with a second study part using daratumumab as maintenance vs. no treatment. 

In the first part of the study, patients were randomized to receive 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). Patients then went on to stem cell transplant and used the Dara-VTd or VTd as consolidation therapy following transplant. 

In the second part of the study, patients that achieved a response underwent a second randomization to either receive maintenance treatment of daratumumab 16 mg/kg every 8 weeks for up to 2 years versus no further treatment (observation). The primary endpoint of this part of the study is progression free survival.

The second part of this study was conducted by the French Intergroupe Francophone du Myelome (IFM), the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and Janssen.

The study showed improved progression free survival and a 47% reduction in the risk of progression or death in patients treated with daratumumab. No new safety concerns were identified. Based on the results, Janssen plans to submit data on the subject at upcoming hematology meetings. 

We hope to learn more details as the American Society of Hematology meeting approaches in December and look forward to finding more effective up-front treatments for newly diagnosed patients.