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Follow-Up Analysis Of Onyx Pharmaceuticals’ Carfilzomib 004 Study Against Refractory Multiple Myeloma

Home/Follow-Up Analysis Of Onyx Pharmaceuticals’ Carfilzomib 004 Study Against Refractory Multiple Myeloma

Follow-Up Analysis Of Onyx Pharmaceuticals’ Carfilzomib 004 Study Against Refractory Multiple Myeloma

Onyx Pharmaceuticals’ Carfilzomib Highlights First Day Of ASCO Meetings In Chicago

Flaunting an impressive 55% success rate in previously treated multiple myeloma patients, Onyx Pharmaceuticals revealed the results of their ongoing Phase 2 clinical carfilzomib study, 004 at the American Society of Clinical Oncology (ASCO) meetings here in Chicago.

Carfilzomib is a selective, next-generation proteasome inhibitor, similar to the already established Velcade. Onyx officials have been claiming carfilzomib is more effective and has fewer side effects than Velcade since December of 2009. The company has also touted the fact carfilzomib may be effective in patients who have become resistant to Velcade.

The sample sizes of this study were relatively small–only 155 patients took part. Still, results from their Phase 2-004 study seem to back-up Onyx’s claims.

Dr. Ravi Vij, Associate Professor, Department of Medicine, Oncology Division, Bone Marrow Transplantation & Leukemia Section at the Washington University School of Medicine explains:

“Although there are no direct comparative studies, based on historical controls, carfilzomib is exhibiting one of the highest single agent response rates and longest durations of response in patients with multiple myeloma who have had one to three prior therapies in this ongoing Phase 2 study. The data from this trial support carfilzomib’s potential to benefit patients with multiple myeloma who are no longer responding to current therapies.”

In a one-on-one interview today, Onyx Pharmaceuticals’ Research Director, Dr. Michael Kauffman revealed Dr. Vij’s interpretation was conservative. “The average patient in our 004 study had already undergone five different therapies before participating. I’m also excited about how well carfilzomib is tolerated.” Dr. Kauffman added.

The news was not as good for patients who had previously used Velcade. Still, 21% of these patients achieved overall response rates. Overall response is defined by the company as a partial response or greater.

Both Velcade naive groups and those who had formerly used Velcade also achieved extended time to progression responses as well. Time to progression is another way of saying the myeloma has begun to come back.

“This data from the 004 study will be included in the planned U.S. New Drug Application (NDA) that we intend to file by year-end 2010, pending top-line data from the ongoing registration trial, known as the 003-A1 study. The results from 003-A1, a Phase 2b trial, will form the basis for the NDA, which we expect to file under the accelerated approval mechanism,” stated Michael Kauffman. “In addition, we have announced our intention to initiate an international Phase 3 clinical trial evaluating carfilzomib in combination with lenalidomide and low dose dexamethasone in earlier stage myeloma. This trial is being conducted through a Special Protocol Assessment with the U.S. Food and Drug Administration and with Scientific Advice from the European Medicines Agency.”

Potentially good news for the thousands of multiple myeloma patients waiting for the next successful and FDA approved novel therapy drug.