11.10.16
Janssen Biotech has entered into a master clinical trial collaboration and supply agreement with Onyx Pharmaceuticals, Inc., a subsidiary of Amgen, to evaluate the efficacy and safety of 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 to treat cancer. Janssen licensed daratumumab from Genmab and is responsible for all global development, marketing and manufacturing. Carfilzomib is developed and commercialized by Amgen.
The first study will focus on a Phase III study to determine if daratumumab in combination with carfilzomib 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. Amgen will sponsor the trial. Financial terms were not disclosed.
"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 R&D, 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 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.
The first study will focus on a Phase III study to determine if daratumumab in combination with carfilzomib 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. Amgen will sponsor the trial. Financial terms were not disclosed.
"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 R&D, 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 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.