Kyprolis carfilzomib: Additional Phase III data

Additional 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 secondary endpoint of improving ORR vs. Revlimid and low-dose dexamethasone alone (87.1% vs. 66.7%, p<0.001). In the Kyprolis arm, 31.8% of patients had a complete response or better vs. 9.3% in the control arm (p<0.001). Median duration of response was 28.6 months in the Kyprolis arm vs. 21.2 months for the control arm. Kyprolis plus Revlimid and low-dose dexamethasone also significantly improved HR-QoL vs. Revlimid and low-dose dexamethasone alone (p<0.001). Amgen said data for the secondary endpoint of OS are still not yet mature, but show a trend in favor of the Kyprolis arm (HR=0.79, 95% CI: 0.63, 0.99, p=0.04). Kyprolis plus Revlimid and low-dose dexamethasone led to a 2-year OS rate of 73.3% vs. 65% for Revlimid and low-dose dexamethasone alone. Data were published in The New England Journal of Medicine and presented at the American Society of Hematology meeting in San Francisco. ...