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Janssen, Genentech link up for clinical trial deal
RARITAN, N.J.—Janssen Research & Development, LLC and Genentech, a member of the Roche Group, have launched a clinical trial collaboration agreement. The two companies will initiate two studies to determine the safety and tolerability of daratumumab (DARZALEX), the first CD38-directed monoclonal antibody (mAb), in combination with atezolizumab, an investigational mAb designed to bind with programmed cell death-ligand 1 (PD-L1). These studies will investigate the potential of the combination therapy in both multiple myeloma and in solid tumors. Atezolizumab is currently in development by Roche. Janssen has licensed daratumumab from Genmab A/S and is responsible for development and marketing of the compound.
Per the terms of the collaboration, Janssen will sponsor a Phase 1b, open-label, multicenter study to assess the potential of daratumumab in combination with atezolizumab in patients with solid tumors. Genentech is the sponsor of an ongoing Phase 1b, open-label, multicenter study that will be amended to assess atezolizumab in combination with daratumumab, with daratumumab and lenalidomide, and with daratumumab and pomalidomide in patients with relapsed or refractory multiple myeloma. It is expected that both studies will start dosing patients within a year.
“We are excited to see if the immunomodulatory properties of daratumumab may have synergistic treatment effects when used in combination with this promising anti-PDL1 antibody,” Dr. Peter F. Lebowitz, global oncology head for Janssen Research & Development, said in a press release. “This is the first time we’re exploring daratumumab in solid tumor, and we look forward to better understanding how combining these two immunotherapies may potentially benefit patients with multiple myeloma and solid tumor, who are urgently in need of new options.”
DARZALEX received approval from the U.S. Food and Drug Administration this past November 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. This indication is approved under accelerated approval based on response rate.
Janssen also announced this week that, along with Bayer, its development partner, it would make 13 data presentations at the American College of Cardiology’s 65th Annual Scientific Session, including real-world findings regarding the safety of XARELTO (rivaroxaban) in a high-risk group of patients with non-valvular atrial fibrillation and concomitant diabetes. The data from the 13 abstracts come from the XARELTO EXPLORER program, and other topic areas to be covered include adherence, hospitalization length of stay and hospital costs, including outcomes for patients being treated for venous thromboembolism.
SOURCE: Janssen press release