The Janssen Pharmaceutical Companies of Johnson & Johnson announced results from the randomized Phase 2 GRIFFIN (MMY2004) study showing that the addition of DARZALEX® (daratumumab) to bortezomib, lenalidomide and dexamethasone (VRd) induced higher response rates in newly diagnosed patients with multiple myeloma who were eligible for high-dose therapy and autologous stem cell transplantation (ASCT) compared with VRd alone.
"The GRIFFIN study is the second randomized study to investigate the benefit of daratumumab for patients with newly diagnosed multiple myeloma who are eligible for a transplant, and the first in combination with lenalidomide for this population," said Peter M. Voorhees, M.D., GRIFFIN principal investigator at Levine Cancer Institute. "This study adds to the growing body of evidence for the addition of daratumumab to proteasome inhibitor/immunomodulatory combination therapy in the transplant setting."
Results from the Phase 2 GRIFFIN study showed that by the end of six cycles of therapy and transplant, a greater percentage of patients receiving DARZALEX®-VRd achieved the primary endpoint of stringent complete response (sCR) compared with VRd alone (42 percent vs. 32 percent, respectively; Odds Ratio [OR] = 1.57; 95 percent confidence interval [CI], 0.87-2.82; P=0.1359), meeting the prespecified 2-sided alpha of 0.2 for a positive study. The addition of DARZALEX® to VRd resulted in higher rates of overall response (99 percent vs. 92 percent), very good partial response or better (91 percent vs. 73 percent) and complete response (CR) or better (52 percent vs. 42 percent) compared with VRd alone, respectively. Notably, the rate of minimal residual disease (MRD) negativity among patients achieving a CR or better more than doubled in the DARZALEX®-VRd arm compared with VRd alone (59 percent vs. 24 percent). The most common (≥10 percent) Grade 3/4 treatment-emergent adverse events (TEAEs) for DARZALEX®-VRd were neutropenia (32 percent), lymphopenia (23 percent), thrombocytopenia (16 percent) and leukopenia (15 percent). Grade 1/2 infections occurred more frequently in the DARZALEX®-VRd arm, but there was no difference in the rate of Grade 3/4 infections between the DARZALEX®-VRd and VRd arms. Infusion-related reactions (IRRs) occurred in 41 percent of patients who received DARZALEX®-VRd, which were primarily Grade 1/2 and during the initial infusion.
"This primary analysis of the GRIFFIN study builds on the safety and efficacy data in the initial group of 16 patients presented at the 2018 American Society of Hematology Annual Meeting," said Andree Amelsberg, M.D., MBA, Vice President, Oncology Medical Affairs, Janssen Biotech, Inc. "It provides further support for evaluation of DARZALEX® in the transplant-eligible patient population, which is important as we continue our work to discover new therapeutic approaches to improve outcomes for patients."
In addition to GRIFFIN, data from the Phase 2 PLEIADES (MMY2040) study, presented during an oral session at the IMW meeting, showed that an investigational DARZALEX® subcutaneous (SC) formulation delivered in combination with standard-of-care treatment regimens showed similar clinical activity and safety to DARZALEX® intravenous (IV) regimens. The study is the first to evaluate SC DARZALEX® in different combination regimens for patients with newly diagnosed multiple myeloma as well as those who were relapsed/refractory to current treatment options.
"We're excited about the opportunity to progress the innovation represented by the DARZALEX® subcutaneous formulation, which can be administered over the course of minutes and has the potential to offer a reduction in infusion-related events as compared to the approved intravenous formulation," said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development. "Data from the PLEIADES study demonstrates that the DARZALEX® subcut...
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