Janssen Biotech is seeking to expand the scope of Darzalex as a second-line combination treatment for multiple myeloma.
The company has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for the use of Darzalex (daratumumab) in combination with Celgene's Revlimid (lenalidomide) and dexamethasone, or Takeda's Velcade (bortezomib) and dexamethasone, for the treatment of patients with multiple myeloma who received at least one prior therapy.
The submission includes data from two Phase III studies: the CASTOR study of Darzalex in combination with Velcade/dexamethasone versus the latter two alone in patients with relapsed or refractory multiple myeloma, and the POLLUX study of the drug in combination with Revlimid/dexamethasone versus the latter two alone in patients with relapsed or refractory multiple myeloma.
According to data from CASTOR, presented at the American Society of Clinical Oncology (ASCO)'s annual meeting, the combination cut the risk of cancer progression and death by 61 percent and significantly increased the overall response rate to 83 percent from 63 percent.
The POLLUX trial showed that patients who received treatment with Darzelex in combination with Revlimid and dexamethasone had a 63 percent reduction in risk of their disease progressing, compared to those who did not receive Janssen/Genmab's drug.
Darzalex already carries a Breakthrough Therapy Designation for this patient population, and submission of the sBLA triggers milestone payments to partner Genmab totalling $15 million.
"We believe that if approved, daratumumab has the potential to make a substantial positive impact in the treatment of patients with multiple myeloma who have relapsed on their previous therapy," said Jan van de Winkel, chief executive of Genmab.
The drug is approved in the US and EU as a monotherapy for pre-treated patients with the blood cancer.