Janssen Biotech and Bristol-Myers Squibb will collaborate in a clinical trial program to evaluate the combination of Darzalex (daratumumab) and Opdivo (nivolumab) in multiple myeloma patients and in several solid tumors in Phase 1b and Phase 2 trials.
Darzalex and Opdivo are two immunotherapy agents that are meant to boost the immune system’s activity against tumor cells. Darzalex is an antibody that targets the CD38 molecule — found at the surface of most myeloma cells — and induces strong immune responses against CD38-positive cells.
Opdivo is an immune checkpoint inhibitor that binds and blocks the activation of PD-1 in T-cells, enhancing their ability to recognize and attack tumor cells.
The myeloma study will assess the safety and tolerability of Darzalex plus Opdivo with or without Pomalyst (pomalidomide) and dezamethasone in relapsed or refractory multiple myeloma patients.
The solid tumor studies will evaluate the safety, tolerability, and effectiveness of Darxalex plus Opdivo in patients with advanced or metastatic tumors. Those will include not only tumors for which Opdivo is already approved, such as non-small cell lung cancer (NSCLC) and head and neck cancers, but also pancreatic, colorectal, and triple-negative breast cancers, and possibly other tumor types. The studies are set to start this year.
“Immunotherapy has vastly changed the way cancer is treated. We are excited to study this novel combination of two potentially synergistic immunotherapies,” Peter F. Lebowitz, MD, PhD, global oncology head of Janssen Research & Development, said in a news release.
“This agreement allows us to extend our footprint in immuno-oncology and will be a significant addition to the growing body of clinical data for [Darzalex] in combination with other novel agents, in a variety of tumor types,” he said.
In November 2015, Darzalex became the first CD38-targeting antibody to be approved anywhere. It was approved as a monotherapy for myeloma patients who have received at least three prior lines of therapy, including a proteasome inhibitor such as Velcade, and an immunomodulatory agent such as Revlimid.
Later, in November 2016, the FDA extended Darzalex’s indications to be used in combination therapy with either Revlimid (lenalidomide) and dexamethasone, or Velcade (bortezomib) and dexamethasone, in refractory myeloma patients.