THOUSAND OAKS (dpa-AFX) - Amgen, Inc. (AMGN) announced Tuesday that Phase 3 KYPROLIS CLARION study in newly diagnosed multiple myeloma patients did not meet the primary endpoint of superiority in progression-free survival.
The Phase 3 CLARION trial evaluated an investigational regimen of KYPROLIS (carfilzomib), melphalan and prednisone (KMP) versus Velcade (bortezomib), melphalan and prednisone (VMP) for 54 weeks in patients with newly diagnosed multiple myeloma who were ineligible for hematopoietic stem-cell transplant.
The company said the trial did not meet the primary endpoint of superiority in progression-free survival. While the data for overall survival, a secondary endpoint, are not yet mature, the observed hazard ratio was 1.21. Neither result was statistically significant.
Overall, the adverse events in the KMP arm were consistent with the known safety profile of KYPROLIS.
The company said these data will be submitted to a future medical conference and for publication.
Sean Harper, executive vice president of Research and Development at Amgen, said, '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. 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.'
The company said it remains committed to exploring KYPROLIS in combination with other agents to advance the treatment of multiple myeloma.
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