New Myeloma Combo (carfilzomib/dara/dex) Submitted for FDA Approval
A new combination of multiple myeloma therapies has been submitted for FDA approval this week. Janssen submitted the request to the FDA for the use of daratumumab (Darzalex), carfilzomib (Kyprolis) and dexamethasone for relapsed or refractory multiple myeloma treatment.
The request was made based on the results of the CANDOR study data, a Phase III study that compared the triplet (carfilzomib/dara/dex) with a doublet (carfilzomib/dex) for patients who had relapsed after 1-3 prior lines of treatment.
The idea of using myeloma therapies in combination without an immunomodulator (lenalidomide or pomalidomide) is a new one. While immunomodulators are considered a “standard” in myeloma combinations, some patients relapse after these drugs and patients are left without effective options. This new combination would provide a powerful alternative for patients in that situation.
In the CANDOR study, 466 relapsed myeloma patients were divided into the KDd arm or the Kd arm.
The study endpoint was progression free survival, or how long patients lived without relapsing. Study results included:
Progression free survival at 17 months:
- 37% lowered risk of disease progression in the KdD arm
- Median progression free survival wasn’t reached by the end of 17 months for the KdD arm
- Median progression free survival was 15.8 months for the Kd arm
Overall response rates:
- 84.3% for KDd patients
- 74.7% for Kd patients
Patients had a better depth of response as well. Minimal residual disease (MRD) negativity at one year was 10x better with the triplet combination.
- 12.5% for KDd patients
- 1.3% for Kd patients
The addition of daratumumab made a big difference. We hope to see rapid FDA approval as all of these drugs have already been approved in other myeloma combinations and we look forward to patients having one more option.