Amgen's Multiple Myeloma Drug Kyprolis Fails In Phase III
Zacks Investment Research | Sep 28, 2016 07:10AM ET
Biotech major, Amgen, Inc. (NASDAQ:AMGN) announced that its multiple myeloma drug Kyprolis did not meet the primary endpoint in a phase III head-to-head CLARION study with Velcade.
The CLARION study (n=955) compared Kyprolis (carfilzomib) in combination with melphalan and prednisone with Velcade (bortezomib), melphalan and prednisone for 54 weeks in newly diagnosed multiple myeloma patients. The study did not establish superiority in progression-free survival (PFS) – the primary endpoint – of the Kyprolis arm over the Velcade arm. While the PFS was 22.3 months in the Kyprolis arm, it was 22.1 months for Velcade. Though not yet mature, overall survival (OS – a secondary endpoint) data shows the hazard ratio was 1.21, which is not statistically significant.
According to management, significant change in the “myeloma landscape” since the design of the CLARION study was responsible for its failure. Lately, the use of melphalan and prednisone in newly diagnosed multiple myeloma patients has been declining in clinical practice in the U.S.
Amgen will present the full data set, most probably at the upcoming American Society for Hematology (ASH) meeting in December.
Kyprolis is currently marketed for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three previous treatments for multiple myeloma. Kyprolis is also approved for use in combination with dexamethasone or with Revlimid (lenalidomide) plus dexamethasone.
However, sales of Kyprolis, which became a part of Amgen’s portfolio following its acquisition of Onyx in 2013, have been below expectations in the first half of 2016, due to increased competition in the multiple myeloma market. The negative CLARION readout is therefore a setback for Amgen.
Kyprolis is being studied in a range of combinations and patient population that includes an investigator-sponsored phase III ENDURANCE study. The study compares Kyprolis in combination with Revlimid and dexamethasone, versus Velcade in combination with Revlimid and dexamethasone, in newly diagnosed multiple myeloma patients.
Shares of Amgen were down more than 1% on Tuesday.
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