Amgen Gets CHMP Nod To Add ENDEAVOR Data On Kyprolis Label

Amgen (NASDAQ:AMGN) announced that it received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, recommending addition of an updated overall survival (OS) data from a phase III head-to-head study on the label of its multiple myeloma drug, Kyprolis (carfilzomib).

The phase III ENDEAVOR study was conducted on 929 patients. Data from the trial demonstrated that a combination of Kyprolis plus dexamethasone (Kd) led to superior overall survival when compared with Takeda Pharmaceutical’s Velcade plus dexamethasone (Vd) in second-line multiple myeloma setting. Findings showed that the combination therapy reduced the risk of death by 21% and increased OS by 7.6 months compared with Vd in the given patients’ population.

Importantly, in January 2018, Amgen announced that the FDA has approved its supplemental New Drug Application (sNDA) to include OS data from the ENDEAVOR program on Kyprolis’ label. The FDA’s decision comes much earlier than expected, initially expected in April this year.

Note that the Kd regimen is already approved in the United States, EU and other countries based on the primary analysis of a progression-free survival in the ENDEAVOR study. This overall survival data, if approved, can help drive the usage of Kyprolis and boost its sales.

We remind investors that Kyprolis is also approved in the United States as a single agent for treating patients with multiple myeloma, who have received at least two prior therapies including Velcade and an immunomodulatory agent.

Significantly, Amgen collaborated with Johnson & Johnson (NYSE:JNJ) in November 2016 to study the combination of Kyprolis and J&J’s Darzalex in multiple clinical studies for addressing the case of multiple myeloma. Under the terms of the agreement, the first study — a phase III registrational trial, evaluating the combo therapy of Kyprolis/Darzalex and dexamethasone compared with Kyprolis and dexamethasone alone on patients with multiple myeloma, having undergone one, two or three prior lines of therapy — has been initiated.

Amgen’s shares have outperformed the industry in a year’s time. The stock has rallied 22.1%, comparing favorably with the industry’s increase of 8%.

Incidentally, Kyprolis, which became part of Amgen’s portfolio following its acquisition of Onyx, registered sales of $608 million in the first nine months of 2017, up 18.9% compared with the year-ago figure. The drug’s label expansion would immensely expand the patient population as well as its commercial potential.

Per the company’s press release, multiple myeloma is an aggressive disease, accounting for approximately one percent of all cancers. Moreover, around 39,000 patients are annually diagnosed with multiple myeloma in Europe, of which, almost 61.5% of the cases proves to be fatal. Hence, the market opportunity of the combination therapy is huge in the EU to cater to the unmet need of patients with an additional option to apprehend the life-threatening disease.

Zacks Rank & Key Picks

Amgen carries a Zacks Rank #3 (Hold). Two better-ranked stocks in the health care sector are XOMA Corporation (NASDAQ:XOMA) and Exelixis, Inc. (NASDAQ:EXEL) . While XOMA sports a Zacks Rank #1 (Strong Buy), Exelixis carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

XOMA’s loss per share estimates have narrowed from 99 cents to 42 cents for 2018 over the last 60 days. The company came up with an average beat of 47.92%. The stock has skyrocketed 678.3% in the last 12 months.

Exelixis’ earnings per share estimates have been revised upward from 72 cents to 77 cents for 2018 over the last 60 days. The company pulled off a positive surprise in all the trailing four quarters with an average beat of 572.92%. Share price of the company has soared 68.4% in a year’s time.

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