Most New Myeloma Patients Respond to Carfilzomib in Phase II Trial

December 13, 2011

By Bill Berkrot

(Reuters) - Onyx Pharmaceuticals Inc's experimental drug carfilzomib produced very promising response rates when combined with Revlimid (lenalidomide) and low dose dexamethasone in newly diagnosed multiple myeloma patients, according to data from a small mid-stage study presented on Monday.

Most of the 53 patients in the study responded quickly to the combination therapy and continued to improve with additional treatment cycles, researchers said.

"Efficacy is really truly among the best we've seen across the board among a variety of regimens with or without (bone marrow) transplant," said Dr. Andrzej Jakubowiak, who presented the data at the American Society of Hematology (ASH) meeting in San Diego.

"I think it's going to be one of those regimens which will potentially change the landscape of what we can do if we have those available," predicted Dr. Jakubowiak, director of the multiple myeloma program at the University of Chicago Medical Center and the study's primary investigator.

Onyx is testing carfilzomib in a variety of combinations and as a monotherapy across various stages of multiple myeloma treatment. The company last month filed a U.S. approval application for the drug to treat patients who relapse or are not helped by prior therapy, and said earlier Monday that a Food and Drug Administration decision was expected in July.

In the study of newly diagnosed multiple myeloma patients, 94% experienced a partial response (at least a 50% reduction of disease) after receiving at least one 28-day cycle of the three-drug combination.

After 12 cycles or more, all patients in the study had a very good partial response, defined as 90% reduction of disease, and nearly 80% showed little or no sign of cancer.

"Seventy nine percent of those who stayed on treatment for 12 months or longer are in complete or near complete response," Dr. Jakubowiak said. "These response rates are higher than those achieved by the best established regimens for newly diagnosed multiple myeloma."

After a median follow-up of nine and a half months, all patients who received the carfilzomib, Revlimid, and dexamethasone therapy were still alive and only one had disease progression, researchers said.

In addition, Dr. Jakubowiak said, most patients were able to remain on their original dosing without developing peripheral neuropathy, which has been a problem with other myeloma treatments.

"Those three drugs when combined together are very well tolerated for an extended period of time," Dr. Jakubowiak said.

Revlimid is approved to treat only multiple myeloma patients who had received at least one prior therapy. It is also being tested as an initial treatment in other Celgene-sponsored studies.

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