Janssen, Amgen in Pact for Combo Cancer TherapyBy
Janssen Biotech, a Johsnon & Johnson company, has entered into a master clinical trial collaboration and supply agreement with Onyx Pharmaceuticals, the wholly owned South San Francisco, California-based subsidiary of Amgen, to evaluate the efficacy and safety of Darzalex (daratumumab) in combination with Kyprolis (carfilzomib), a proteasome inhibitor (PI), and dexamethasone for treating cancer.
Janssen licensed daratumumab from Genmab, a Copenhagen, Denmark-headquartered biotechnology company. Janssen is responsible for all global development, marketing, and manufacturing of daratumumab). Carfilzomib is developed and commercialized by Amgen. Financial terms of the agreement were not disclosed.
Under the agreement, the companies may elect to supply drug only or supply drug and share development costs on a study-by-study basis. The first study under this collaboration will focus on a Phase III study to determine if daratumumab in combination with carfilzomib (56 mg/m2 twice weekly) and dexamethasone improves progression-free survival, 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 agreement, the trial will be sponsored by Amgen.
Darzalex is a CD38-directed monoclonal antibody approved to treat patients with multiple myeloma. It was approved by the US Food and Drug Administration (FDA) in November 2015 for treating 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.
In August 2016, Janssen submitted a supplemental biologics license application to the FDA for daratumumab in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for treating patients with multiple myeloma who have received at least one prior therapy. Daratumumab was granted breakthrough therapy designation from the FDA for this indication in July 2016. Darzalex is the brand name under which daratumumab is commercialized in the US by Janssen.
Kyprolis is a PI approved in the US and Canada as a single agent for treating 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 patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. As part of an earlier and separate agreement, Amgen is also supplying Kyprolis for Janssen’s open-label Phase Ib study.