Amgen and Janssen to co-fund studies with Kyprolis and Darzalex in patients with multiple myeloma

The first study initiated as part of this agreement is a Phase III registrational trial evaluating Kyprolis in combination with Darzalex and dexamethasone compared to Kyprolis and dexamethasone alone.

The first study initiated as part of this agreement is a Phase III registrational trial evaluating Kyprolis in combination with Darzalex and dexamethasone compared to Kyprolis and dexamethasone alone in patients with multiple myeloma who have had one, two or three prior lines of therapy. The rationale for combining these agents is that they have demonstrated substantial activity in multiple myeloma, with distinct and complementary mechanisms of action. The study is anticipated to start enrolling patients in April 2017.

"Given the relapsing nature of multiple myeloma, several options are needed to attack the disease differently and keep patients in remission as long as possible," said Sean E. Harper, executive vice president of Research and Development at Amgen. "We are excited to collaborate with Janssen to evaluate the potential of combining Kyprolis, a powerful proteasome inhibitor, with Darzalex, the first human anti-CD38 monoclonal antibody for the treatment of multiple myeloma in the relapsed setting."

As part of an earlier and separate agreement, Amgen is also supplying Kyprolis for Janssen's open-label Phase Ib study. The combination of Darzalex and Kyprolis is being investigated in this Phase Ib study in two cohorts. One cohort includes Darzalex in combination with Kyprolis and dexamethasone in patients who previously received one to three prior lines of therapy. The second cohort includes Darzalex in combination with Kyprolis, Revlimid (lenalidomide) and dexamethasone in subjects with newly diagnosed multiple myeloma, regardless of transplantation eligibility. Both Phase I cohorts are fully enrolled.