Onyx Pharmaceuticals, Inc. (ONXX), a biopharmaceutical company, Sunday announced updated safety data from a pivotal Phase 2b 003-A1 study known as 003 trial, indicating that its next generation proteasome inhibitor carfilzomib is well-tolerated in heavily pre-treated relapsed and refractory multiple myeloma or hematologic cancer patients.
While presenting data at the annual meeting of the American Society of Hematology, Onyx Pharma also noted that the enrollment in this trial is complete with full results being expected in the year 2010. Onyx Pharma also said it anticipates filing a potential new drug application for carfilzomib by year-end 2010.
Carfilzomib is a selective, next generation proteasome inhibitor, which is currently undergoing evaluation as a single agent in multiple Phase 2 and Phase 1 clinical trials in relapsed or refractory multiple myeloma. Multiple myeloma is the second most common hematologic cancer and results from an abnormality of plasma cells, usually in the bone marrow.
Lead investigator Sundar Jagannath, chief of the Multiple Myeloma Program, Bone Marrow and Blood Stem Cell Transplantation at St. Vincent's Comprehensive Cancer Center in New York said, "These results show that carfilzomib is well-tolerated and can be administered at a full dose over a long period of time even in a very sick patient population for whom all available treatment options have been exhausted and who have multiple comorbidities."
Consistent with the Phase 2b 003-A1 results, Onyx Pharma has also presented results from the Phase 2 003-A0 study, which was initially presented at the American Society for Clinical Oncology annual meeting in June 2009. The study that recruited patients whose myeloma had relapsed from two or more prior therapies and was refractory to their previous therapy was the lead-in study for the current Phase 2b registrational trial in the same population.
Previously presented efficacy data from the 003-A0 pilot study included an 18% overall response rate and a 26%clinical benefit rate, median time to tumor progression of 5.1 months and a median of 7.4 months response duration.
The primary endpoint for the Phase 2b 003-A1 pivotal study was overall response rate, while secondary endpoints include clinical benefit response, duration of response, progression-free survival, time-to-progression, overall survival and safety.
According to the new safety data from the 003-A1 trial, carfilzomib was found to be well tolerated at the 27 mg/m(2) dose. Grade 3/4 hematologic events included 13.5% anemia, 16.3% thrombocytopenia, 3.5% neutropenia, and 0.7% febrile neutropenia. The rate of grade 3/4 peripheral neuropathy was 0.7%.
ONXX closed Friday's regular trading at $29.77, down $0.02 or 0.07%, on a volume of 0.77 million shares. In after-hours, the stock gained $0.53 or 1.78%, to trade at $30.30.
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