Addition of Darzalex to Chemotherapy Shows Promise in Myeloma

The combination use of Darzalex (daratumumab) in combination with Revlimid (lenalidomide), Velcade (bortezomib) and Ozurdex (dexamethasone), also known as VRd, demonstrated a higher percentage of stringent complete responses among transplant eligible, newly diagnosed patients with multiple myeloma, according to topline results from the phase 2 GRIFFIN study.

“The data from the phase 2 GRIFFIN trial underlines the potential of daratumumab when used in combination with VRd and supports Janssen’s decision to start the PERSEUS and CEPHEUS phase 3 studies of daratumumab in combination with VRd for certain frontline multiple myeloma indications,” said Dr. Jan van de Winkel, chief executive officer of Genmab, the drug’s manufacturer.

The randomized, open label, parallel assignment trial, which included 223 patients with newly diagnosed multiple myeloma who were eligible for high-dose chemotherapy and autologous stem cell treatment, met its primary endpoint of a higher rate of stringent complete response compared with VRd alone (42.4% vs. 32.0%).

Secondary endpoints, including the results of the minimal residual disease analysis, supported the primary endpoint backing the use of Darzalex in combination with VRd.

Further analysis of the safety and efficacy data is ongoing and Janssen Biotech, Inc., which licensed Darzalex from Genmab in 2012, has plans to present additional data at an upcoming medical summit.

Overall, the safety profile of Darzalex used in combination with VRd was consistent with the safety profile for each separate therapy, which has been reported from previous studies.

“This data also builds on the efficacy and safety data for daratumumab as a frontline treatment for transplant eligible multiple myeloma patients as seen in the CASSIOPEIA phase 3 study in which newly diagnosed patients with multiple myeloma who were candidates for (autologous stem cell transplantation) were treated with daratumumab combined with an immune-modulatory drug and a proteasome inhibitor,” van de Winkel added.