(CHICAGO, IL) – Carfilzomib is an effective and tolerable replacement for bortezomib for patients who are refractory to bortezomib-containing combination regimens for the treatment of multiple myeloma, according to the results of a Phase 1/2 study presented at the 2012 American Association of Clinical Oncology Annual Meeting.
Data have shown multiple myeloma patients previously refractory to bortezomib-containing treatment regimens to be responsive to single-agent carfilzomib (CFZ), explained lead author James R. Berenson, MD, a medical oncologist in private practice in West Hollywood, CA. As a follow-up to these data, Berenson and his colleagues conducted a Phase 1/2 trial to investigate the safety and efficacy of carfilzomib as a replacement for bortezomib in a combination regimen for patients who progressed on, or within 12 weeks of receiving, that same combination regimen when containing bortezomib.
Twenty-seven patients were enrolled and 22 were evaluable and treated with CFZ and the following different combinations: bendamustine (BEND) alone; BEND + methylprednisolone; dexamethasone (DEX) alone; DEX + pegylated liposomal doxorubicin; ascorbic acid + cyclophosphamide; and melphalan alone. At the time of this presentation, patients had already completed a median of 6 cycles.
Clinical benefit was seen in 63.6% (n=14) patients (complete response=22.7%; very good partial response=4.5%; partial response=22.7%; minor response=13.6%) with another 27% (n=6) showing stable disease. The median time to progression and progression-free survival was 9.8 months. The most common grade 3/4 hematological adverse events were thrombocytopenia (59%) and lymphopenia (41%).
Investigators concluded that Carfilzomib is an effective and tolerable replacement for bortezomib for patients who are refractory to bortezomib-containing combination regimens for the treatment of multiple myeloma.