Janssen Research & Development has reported positive results from the updated Phase III CASTOR and POLLUX clinical trials of Darzalex (daratumumab) combined with bortezomib and dexamethasone or lenalidomide and dexamethasone to treat patients with multiple myeloma.
The Darzalex injection is a CD38-directed antibody thought to trigger tumour cell death via multiple immune-mediated mechanisms.
The results indicated improvement in progression-free survival (PFS) and the overall response rate (ORR) in previously treated subjects, regardless of cytogenetic risk.
The follow-up results from the CASTOR trial with daratumumab + bortezomib + dexamethasone combination showed a significant decrease in risk of disease progression or death by 55% in patients with high-risk cytogenetics when compared to dexamethasone alone.
The findings from the POLLUX trial of daratumumab + lenalidomide + dexamethasone combination indicated reduced risk of disease progression or death by 47% in same setting as the CASTOR trial.
The ORR rate was 82% versus 62% in CASTOR trial, while it was found to be 85% versus 67% in POLLUX.
Additionally, daratumumab showed favourable results in the Phase Ib MMY1001 when administered in combination with carfilzomib, lenalidomide and dexamethasone to treat newly diagnosed multiple myeloma patients.
Janssen Research & Development oncology therapeutic area head Peter Lebowitz said: “Together, this data for daratumumab demonstrates its potential as a backbone therapy in combination with a range of standard-of-care regimens for patients with multiple myeloma across various stages of disease.
“We are especially excited by early data for daratumumab showing its potential in the frontline setting and look forward to fully understanding its potential clinical benefit for patients with cancer.”