BioCentury
ARTICLE | Clinical News

Kyprolis carfilzomib: Interim Phase III data

August 11, 2014 7:00 AM UTC

Interim data from the open-label, international Phase III ASPIRE trial in 792 patients with relapsed MM following treatment with 1-3 prior regimens showed that Kyprolis plus Revlimid lenalidomide and low-dose dexamethasone met the primary endpoint of improving median PFS vs. Revlimid and low-dose dexamethasone alone (26.3 vs. 17.6 months, p<0.0001). Amgen said data for the secondary endpoint of OS are not yet mature, but show a non-significant trend in favor of the Kyprolis arm. The safety profile in ASPIRE was consistent with the Kyprolis U.S. label, including the rate of cardiac events. Amgen plans to submit the data for presentation at the American Society of Hematology meeting in San Francisco in December.

In 2012, FDA granted accelerated approval to Kyprolis to treat MM in patients who have received >=2 prior lines of therapy that include bortezomib and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of completion of the last therapy. Onyx Pharmaceuticals Inc., now part of Amgen, was required to complete ASPIRE as part of accelerated approval. Onyx has an SPA from FDA for ASPIRE and received scientific advice from EMA on the design and analysis of the trial. Based on the ASPIRE data, Amgen plans to submit regulatory applications worldwide for Kyprolis beginning in 1H15. ...