Amgen's Multiple Myeloma Drug Kyprolis Fails In Phase III

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.

Amgen currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Anika Therapeutics Inc (NASDAQ:ANIK) , ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) and Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) .

Anika Therapeutics’ earnings estimates for 2016 and 2017 were up a respective 12.6% and 14% over the last 60 days. The company has recorded a positive earnings surprise in each of the last four quarters with an average beat of 42.19%. Its share price has surged almost 22% year to date. Anika Therapeutics currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

ANI Pharmaceuticals has a Zacks Rank #1 as well. The company witnessed an increase of 9.5% and 4.7% in its earnings estimates for 2016 and 2017, respectively, in the last 60 days. It has beaten earnings estimates twice in the last four quarters, bringing the average positive surprise to 46.85%. The company’s share price has surged more than 50% year to date.

Ligand Pharmaceuticals carries a Zacks Rank #1. Over the past 60 days, the company’s earnings estimates for 2016 and 2017 increased 12.1% and 25.6%, respectively. It has delivered a positive earnings surprise in three of the last four quarters, resulting in an average beat of 36.66%.

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