On September 13, Amgen announced that the Phase III CANDOR study had met its primary endpoint. In patients with relapsed or refractory multiple myeloma, treatment with Kyprolis (carfilzomib) plus dexamethasone and Darzalex (daratumumab) significantly prolonged progression-free survival compared to Kyprolis (carfilzomib) plus dexamethasone (not yet mature vs. 15.8 months), reducing the risk of disease progression or death by 37% (HR=0.630; 95% CI: 0.464, 0.854; p=0.0014).
The CANDOR study employed a randomized, open-label design and enrolled 466 patients with relapsed or refractory multiple myeloma who had received one to three prior lines of therapy. Patients were treated with either carfilzomib (56 mg/m² twice weekly) plus dexamethasone and daratumumab, or carfilzomib (56 mg/m² twice weekly) plus dexamethasone, until disease progression.
Regarding safety, the triple therapy group reported a higher incidence of adverse events, with the most common (≥20%) being thrombocytopenia, anemia, diarrhea, hypertension, upper respiratory tract infection, fatigue, and dyspnea. The types of adverse events associated with triple therapy were consistent with those observed when each drug was used individually.
Multiple myeloma is an incurable blood cancer originating from plasma cells in the bone marrow (the final functional stage of B-lymphocyte development). It is characterized by cycles of relapse and remission and accounts for approximately 1% of all cancer cases. Globally, there are approximately 160,000 new diagnoses and 106,000 deaths annually.