Kyprolis carfilzomib: Phase III data
Top-line data from the open-label, international Phase III CLARION trial in 955 patients with newly diagnosed MM who were ineligible for a hematopoietic stem cell transplant (HSCT) showed that IV Kyprolis plus melphalan and prednisone for 54 weeks missed the primary endpoint of improving median PFS vs. Velcade bortezomib plus melphalan and prednisone (22.3 vs. 22.1 months, HR=0.91, 95% CI: 0.75, 1.1). On secondary endpoints, Amgen said that OS data are not yet mature and that Kyprolis plus melphalan and prednisone led to an incidence of grade >=2 peripheral neuropathy of 2.5% vs. 35.1% for Velcade plus melphalan and prednisone. The company also said that the treatment landscape has changed since CLARION was designed and that “very few” newly diagnosed MM patients are treated with melphalan-based regimens, particularly in the U.S. Patients received Velcade plus melphalan and prednisone or Kyprolis on days 1, 2, 8, 9, 22, 23, 29 and 30 of each 42-day cycle plus melphalan and prednisone. Amgen said it hopes to present the CLARION data at the American Society of Hematology meeting in San Diego December. The company is not conducting any other studies of Kyprolis in first-line MM. ...