Onyx Pharma said that in independent review of the data, Carfilzomib showed an overall response rate (partial response or greater) of 24% and a median duration of response of 7.4 months in patients who entered the study after receiving a median of five prior lines of therapy (corresponding to a median of 13 anti-myeloma agents) and whose disease was refractory to their last therapeutic regimen. Additionally, Carfilzomib was well-tolerated.
Onyx Pharma stated that it is continuing discussions with the FDA regarding next steps in filing a new drug application (NDA) for Carfilzomib, which the company expects to submit by year-end 2010 for approval in the US.
Onyx Pharma’s 003-A1 study evaluated patients with relapsed and refractory multiple myeloma whose disease was refractory to their last treatment regimen and who had received at least two prior therapies, including bortezomib, either thalidomide or lenalidomide, an alkylating agent, glucocorticoids and an anthracycline.
The trial was conducted in collaboration with the Multiple Myeloma Research Consortium (MMRC) and at additional sites in the US and Canada.
Michael Kauffman, chief medical officer of Onyx Pharmaceuticals, said: “According to a study from the International Myeloma Working Group, patients, such as those enrolled in the 003-A1 study, can expect to respond to therapy only 11% of the time and survive for only six to 10 months.”
Anthony Coles, president and CEO of Onyx Pharmaceuticals, said: “The first study, Aspire, is designed to support full Carfilzomib registration in the US in earlier-stage patients who have relapsed following initial lines of therapy, and the second study is designed to support approval in relapsed and refractory patients in Europe.”
Kathy Giusti, founder and CEO of the MMRC and a multiple myeloma patient, said: “The MMRC initiated a relationship with the company (then Proteolix) in 2006, which included the participation of 11 MMRC Member Institutions in the 003-A1 trial, representing 36% of the total trial centers and 60% of enrolled patients.”