Janssen Biotech Inc has announced that the company has entered into a master clinical trial collaboration and supply agreement with Onyx Pharmaceuticals, Inc., a wholly-owned subsidiary of Amgen, Inc., to evaluate the efficacy and safety of the first-in-class CD38-directed immunotherapy daratumumab (DARZALEX®) in combination with a proteasome inhibitor (PI) carfilzomib (KYPROLIS®) and dexamethasone. The agreement covers all potential opportunities for combining daratumumab and carfilzomib for the treatment of patients with cancer.
Janssen licensed daratumumab from Genmab A/S and is responsible for all global development, marketing and manufacturing.1 Carfilzomib is developed and commercialized by Amgen. The first study under this collaboration agreement will focus on a Phase 3, randomized, open-label, registration study to determine if daratumumab in combination with carfilzomib (56 mg/m2 twice weekly) and dexamethasone improves progression-free survival (PFS), compared to carfilzomib and dexamethasone alone, in patients with multiple myeloma who have received one to three prior therapies.
The study is anticipated to start dosing patients in 2017. Under the terms of the agreement, the trial will be sponsored by Amgen. Financial terms have not been disclosed. As part of an earlier collaboration agreement, a separate, ongoing study is evaluating the safety and pharmacokinetics of this combination regimen, in addition to a second regimen of daratumumab in combination with carfilzomib (70 mg once weekly), lenalidomide and dexamethasone in newly diagnosed patients with multiple myeloma.
This research will build on clinical findings from the Phase 3 POLLUX and CASTOR clinical studies evaluating daratumumab in combination with lenalidomide and dexamethasone, and bortezomib and dexamethasone, respectively, in patients with multiple myeloma who have received at least one prior therapy. Findings from the POLLUX trial were published in The New England Journal of Medicine, with an accompanying editorial, in October 2016, and findings from the CASTOR trial were published in The New England Journal of Medicine in August 2016.
“We are delighted to partner with Amgen to continue to explore the potential role of daratumumab in combination with novel treatment regimens, especially now that we have results from the Phase 3 POLLUX and CASTOR studies,” said Peter F. Lebowitz, M.D., Ph.D., Global Oncology Head, Janssen Research & Development, LLC. “This collaboration reflects our shared vision to better meet the needs of patients with multiple myeloma who are still in need of new therapeutic options.”
DARZALEX is the first CD38-directed monoclonal antibody (mAb) approved to treat patients with multiple myeloma. It was first approved by the FDA in November 2015 as a treatment for patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent or who are double refractory to a PI and immunomodulatory agent.2 This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.3 DARZALEX is also approved in Europe and Canada for a similar patient population.
KYPROLIS is a PI approved in the U.S. and Canada as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy and in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
In August 2016, Janssen submitted a supplemental Biologics License Application (sBLA) to the FDA for daratumumab in combination with lenalidomide (an immunomodulatory agent) and dexamethasone, or bortezomib (a PI) and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.4 Daratumumab received Breakthrough Therapy Designation from the FDA for this indication in July 2016.5
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