Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced updated interim results of the Phase 1b dose-escalation trial, known as the 006 study, evaluating carfilzomib in combination with lenalidomide (Revlimid®) and low dose dexamethasone in patients with relapsed and/or refractory myeloma. These data are being presented today at the 46th American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago by William Bensinger, M.D., Professor of Medicine of the Division of Oncology, Fred Hutchinson Cancer Research Center at the University of Washington School of Medicine.
The overall response rate in the cohorts of patients receiving full doses of the combination was 75 percent in 48 evaluable patients. Median duration of response has not yet been reached. No dose-limiting toxicities were observed, and the maximum tolerated dose was not reached. The maximum per-protocol doses of 27mg/m2 carfilzomib, 25mg lenalidomide, and low dose (40mg) dexamethasone were safely administered. Overall response is measured as a partial response or greater.
"Nearly all patients with multiple myeloma who receive initial treatment will eventually relapse and require further therapy," said Dr. Bensinger. "Although new agents have been developed over the past several years, we require additional treatment options that improve progression-free survival and extend overall response rates with a tolerability profile that is mild and manageable. The interim results from this Phase 1b study show an encouraging efficacy profile in this heavily pretreated group of patients with myeloma, with no overlapping toxicities with the treatment triplet. We look forward to further study of this important carfilzomib-based combination regimen in the upcoming international Phase 3 trial."
Onyx Pharmaceuticals, Inc.