Amgen (AMGN) Announces KYPROLIS Phase 3 CLARION Trial Missed Primary Endpoint

September 27, 2016 5:52 AM EDT

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Amgen (NASDAQ: AMGN) announced top-line results of the Phase 3 CLARION trial, which evaluated an investigational regimen of KYPROLIS (carfilzomib), melphalan and prednisone (KMP) versus VelcadeĀ® (bortezomib), melphalan and prednisone (VMP) for 54 weeks in patients with newly diagnosed multiple myeloma who were ineligible for hematopoietic stem-cell transplant. The trial did not meet the primary endpoint of superiority in progression-free survival (PFS) (median PFS 22.3 months for KMP versus 22.1 months for VMP, HR = 0.91, 95 percent CI, 0.75 - 1.10). While the data for overall survival, a secondary endpoint, are not yet mature, the observed hazard ratio (KMP versus VMP) was 1.21 (95 percent CI, 0.90 - 1.64). Neither result was statistically significant.

Overall, the adverse events in the KMP arm were consistent with the known safety profile of KYPROLIS. The incidence of Grade 3 or higher adverse events was 74.7 percent in the KMP arm and 76.2 percent in the VMP arm. Fatal treatment-emergent adverse events occurred in 6.5 percent of KMP patients and 4.3 percent of VMP patients. The incidence of Grade 2 or higher peripheral neuropathy, a secondary endpoint, was 2.5 percent in the KMP arm and 35.1 percent in the VMP arm.

These data will be submitted to a future medical conference and for publication.

"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," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "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."

Amgen supports a number of investigator-sponsored studies, and a Phase 3 study evaluating KYPROLIS in combination with lenalidomide plus dexamethasone (KRd) versus Velcade in combination with lenalidomide plus dexamethasone (VRd) in newly diagnosed multiple myeloma patients. This trial, called E1A11 or ENDURANCE, is underway independently by the ECOG-ACRIN Cancer Research Group with funding provided by the National Cancer Institute (NCI) and its National Clinical Trials Network. Over 750 institutions nationwide are currently enrolling patients in the study (NCT01863550).

The KYPROLIS clinical program continues to focus on providing solutions for physicians and patients in treating this frequently relapsing and difficult-to-treat cancer. KYPROLIS is available for patients whose myeloma has relapsed or become resistant to another treatment and continues to be studied in a range of combinations and patient populations.

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