Johnson & Johnson’s pharmaceutical division Janssen announced on Monday that it has submitted a new combination of its anti-CD38 antibody Darzalex with the US Food and Drug Administration.
The new application combines Darzalex (daratumumab) with Kyprolis (carfilzomab) and dexamethasone (Dkd), for use in relapsed or refractory multiple myeloma.
The supplemental biologics license application is supported by data from the phase 3 CANDOR study, which compared the Darzalex combo to Kyprolis and dexamethasone alone.
At a median follow-up of 17 months, the study hit its primary endpoint of progression-free survival, demonstrating a 37% reduction in the risk of disease progression or death in patients receiving the Darzalex combination.
It also demonstrated efficacy in key secondary endpoints, including overall survival rate and minimal residual disease negative-complete response at 12 months.
The overall response rate (ORR) was 84.3% compared to 74.7%, and the rate of complete response or better was 28.5% versus 10.4% in the Kyprolis and dexamethasone arm.
“While we continue to make important strides in the treatment of multiple myeloma, unfortunately most patients will relapse at some point, so it is important that physicians have multiple treatment options and regimens for patients,” said Craig Tendler, vice president, late development and global medical affairs, Janssen Research & Development.
“The results from the CANDOR study support the potential benefit of this Darzalex-based combination regimen for patients with multiple myeloma who have relapsed from prior treatment,” he added.
J&J has been expanding the use of Darzalex with a number of combination therapies, including its recently approved Darzalex, bortezomib, thalidomide and dexamethasone (VTd) combination.
Darzalex, which was originally developed by Danish biotech Genmab, is a monoclonal antibody (mAb) that targets the CD38 protein, which is highly expressed on multiple myeloma cells.
It also has an approval for another combination regimen made up of Darzalex, Celgene’s Revlimid (lenalidomide) and dexamethasone, for the treatment of newly diagnosed multiple myeloma patients who are ineligible for ASCT treatment.
Despite having the CD38 category largely to itself since Darzalex was first approved in 2015, J&J could see its exclusivity disappear as Sanofi’s rival anti-CD38 mAb is currently being reviewed by the FDA for the treatment of relapsed/refractory multiple myeloma – with a target action date for a final decision due on 30 April.