Janssen and Onyx Collaborate to Study Darzalex for Cancer Treatment

Janssen has entered a clinical trial collaboration and supply agreement with Onyx to evaluate the efficacy and safety of Darzalex, the first-in-class CD38-directed immunotherapy daratumumab, in combination with a proteasome inhibitor carfilzomib and dexamethasone.

The agreement will cover all potential opportunities for combining daratumumab and carfilzomib for the treatment of cancer. The first study will determine if daratumumab in combination with carfilzomib and dexamethasone improves progression-free survival, compared with carfilzomib and dexamethasone alone, in patients with multiple myeloma who have received 1 to 3 previous therapies.

As a part of a previous agreement, a separate ongoing study is looking at the safety and pharmacokinetics of this combination regimen, as well as a second regimen of daratumumab in combination with carfilzomib (70 mg once weekly), lenalidomide, and dexamethasone.

All future research will build on the clinical findings from the phase 3 POLLUX and CASTOR clinical trials. These studies looked at daratumumab in combination with lenalidomide and dexamethasone, and bortezomib and dexamethasone, in patients with multiple myeloma who had received at least 1 previous therapy.

The most common adverse effects associated with Darzalex are infusion reactions, fatigue, nausea, back pain, and pyrexia. Those who take Kyprolis may experience tiredness, nausea, fever, difficulty breathing, and diarrhea.

"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,” said Peter F. Lebowitz, MD, PhD, Global Oncology Head at Janssen Research & Development, in a press release.