Amgen, Janssen Show Commitment to Multiple Myeloma Research

The companies plan to collaborate on clinical trials of a novel combination therapy for multiple myeloma.

Amgen recently announced plans to collaborate with Janssen Biotech to further multiple myeloma research and treatment options.

The companies will co-fund clinical trials evaluating the use of Amgen’s Kyprolis (carfilzomib) in combination with Janssen’s Darzalex (daratumumab) in previously treated patients with multiple myeloma. The companies may choose to both supply the drug and share costs on a study-by-study basis, according to Amgen.

Kyprolis is a drug that has shown the ability to block proteasomes, which leads to an excess of proteins within cells. Particularly in multiple myeloma cells, this drug can cause cell death since they contain a high amount of abnormal proteins.

It is currently approved in numerous countries for the treatment of patients with relapsed or refractory multiple myeloma as both a monotherapy and a combination treatment.

The first study being conducted under the agreement is a phase 3 trial that evaluates Kyprolis plus Darzalex and dexamthasone compared with Kyprolis plus dexamethasone in patients with multiple myeloma who have undergone previous treatment. Investigators plan to start enrolling patients in this trial as soon as April 2017.

The companies believe the 3-drug combination treatment may be beneficial since they have all shown complementary mechanisms of action in multiple myeloma, Amgen reported. In the first group, patients will receive Kyprolis twice per week (56 mg/m2) and dexamethasone combined with Darzalex.

Patients in the control group will receive Kyprolis twice per week (56 mg/m2) and dexamethasone. The primary endpoint is progression-free survival, and the secondary endpoints include overall response rate, minimal remaining disease, and overall survival.

As part of another agreement, Amgen will also be supplying Kyprolis for a phase 1b clinical trial conducted by Janssen. In this study, investigators will explore the 3-drug combination in previously treated patients, as well as Daralex in combination with Kyprolis, Revlimid (lenalidomide), and dexamethasone in patients with newly diagnosed multiple myeloma.

This investigational 3-drug combination could potentially provide hope to the thousands of patients diagnosed with the incurable cancer each year, which accounts for only 1% of cancers diagnosed.

"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, MD, 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."