Amgen announces top-line CLARION trial results
The trial lasted 54 weeks and tested the regimen on patients with multiple myeloma that had been recently diagnosed. The patients taking part in the study are also ineligible for hemaopoietic stem-cell transplant.
"Based on studies in the KYPROLIS label, including the ENDEAVOR study, a head-to-head comparison of KYPROLIS to Velcade in patients with relapsed or refractory multiple myeloma, we know KYPROLIS to be a major advance in proteasome inhibitor therapy," Amgen EVP of Research and Development Dr. Sean E. Harper said. "The CLARION results, generated in the context of a melphalan-containing regimen, are disappointing, especially given the robust data we've seen in the second-line setting. However, the myeloma landscape has changed dramatically since the design of the CLARION study with very few newly diagnosed patients treated with melphalan-based regimens, particularly in the U.S. We remain committed to exploring KYPROLIS in combination with other agents to advance the treatment of multiple myeloma."
The trial was unsuccessful in meeting its primary goal of superiority in progression-free survival.