Amgen Announces Top-Line Results from Phase 3 KYPROLIS® (Carfilzomib) CLARION Study in Patients with Newly Diagnosed Multiple Myeloma

Amgen Igea Luca Dezzani

Amgen Igea Luca Dezzani

Sept. 27, 2016

Amgen has announced top-line results of the Phase 3 CLARION trial evaluating an investigational regimen of KYPROLIS® (carfilzomib), melphalan and prednisone (KMP) versus CLARION Study® (bortezomib), melphalan and prednisone (VMP) for 54 weeks in patients with newly diagnosed multiple myeloma who were not eligible for hematopoietic stem-cell transplant. The trial did not meet the primary endpoint of superiority in progression-free survival (PFS). The observed hazard ratio (KMP versus VMP) was 1.21 (95 percent CI, 0.90 – 1.64) while the data for overall survival, a secondary endpoint, are not yet mature. Neither result was statistically significant. These data will be submitted to a future medical conference and for publication.

Sean E. Harper, M.D., 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. 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.”

Advertisements

3 thoughts on “Amgen Announces Top-Line Results from Phase 3 KYPROLIS® (Carfilzomib) CLARION Study in Patients with Newly Diagnosed Multiple Myeloma

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s