James R. Berenson, MD
James R. Berenson, MD, Medical and Scientific Director, Institute for Myeloma & Bone Cancer Research, Chief Executive Officer, Oncotherapeutics, discusses the background of the phase I/II study of carfilzomib as a replacement for bortezomib for multiple myeloma (MM) patients refractory to a bortezomib-containing combination regimen.
The idea for the trial, Berenson says, stemmed from the need for a proteasome inhibitor that could overcome resistance to bortezomib. Thirty-two patients were enrolled who had progressed on bortezomib or were within 12 weeks of the last dose. Patients then received a regimen replacing bortezomib with carfilzomib and continued with the other agents in the regimen without change in dosage or schedule.
Clinical benefit was seen in 75% of patients (complete response = 8.3%; very good partial response = 16.7%; partial response = 29.2%; minor response = 20.8%) while another 16.7% showed stable disease.
Berenson was surprised by these impressive results, as well as the safety data, and feels that carfilzomib will be a robust product for patients who fail bortezomib.