In a nutshell
The study evaluated outcomes of the combination of carfilzomib (Kyprolis; K), dexamethasone (Decadron; d), and daratumumab (Darzalex; D) in patients with relapsed or refractory (r/r) multiple myeloma (MM). The authors found that KdD was safe and effective to improve progression-free survival (PFS) in such patients compared to Kd.
Some background
Patients with MM often experience r/r disease after initial therapy with lenalidomide (Revlimid) or bortezomib (Velcade). Relapse refers to cancer’s return. Refractory means when MM stops responding to these drugs. Combinations of KD and dD separately showed benefits in treating patients with r/r-MM. KdD also proved to be safe and effective against r/r-MM in a small clinical trial. However, evidence from larger and late-stage trials are lacking.
Methods & findings
The study included 466 patients with r/r-MM from 4 continents. 312 patients received KdD and 154 received Kd. PFS means how long patients survive without developing cancer again. On average, patients were followed up for 16.9 months in KdD and 16.3 months in Kd groups, for PFS analysis.
No patients on KdD had progression during follow-up. THE average PFS was 15.8 months for the Kd group. The Kd group had a 37% higher risk of progression compared to KdD. Rates of PFS for 18-months were calculated to be 62% in the KdD group and 43% in the Kd group.
Complete response (CR) means the absence of all cancer signs and symptoms. 29% of patients on KdD and 10% on Kd treatments achieved CR. Partial response (PR) refers to at least 50% reduction in cancer. Thw overall response (OR) signifies the proportion of patients having PR or better outcomes. OR was achieved by 84% of patients on KdD and 75% on Kd therapies. Minimal residual disease (MRD) refers to the cancer cells left in the body after therapy. 18% of patients from the KdD and 4% from the Kd groups had no MRD at 12 months after therapy.
Side effects that led patients to stop treatment were reported in 22% of the KdD group and 25% of the Kd group.
The bottom line
The study concluded that KdD was safe and improved PFS and OR in patients with r/r-MM, compared to Kd.
The fine print
This trial was sponsored by Amgen, the manufacturer of carfilzomib.
Published By :
Lancet (London, England)
Date :
Jul 18, 2020
