Amgen (AMGN) Presents Positive Clinical Data On Cancer Drugs

Amgen, Inc. (NASDAQ:AMGN) presented encouraging results from a phase III study, evaluating its marketed drug Xgeva (denosumab) for an expanded indication at the American Society of Clinical Oncology (ASCO). The company is looking to expand Xgeva’s label for treating patients with multiple myeloma (blood cancer).

We remind investors that in Apr 2017, Amgen announced submission of a supplemental biologics license application (sBLA) to FDA to expand the label of Xgeva for the aforesaid indication. Additionally, the company has tendered a request to modify the marketing authorization to European Medicines Agency (EMA).

Xgeva is already approved in the U.S. and the EU for prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. However, same is not the case for multiple myeloma. Xgeva is also approved in the U.S. for treatment of giant cell tumor of bone (GCTB) that cannot be cured through surgery in adults and skeletally mature adolescents.

Amgen’s share price movement shows the stock to outperform the Zacks classified Medical - Biomedical and Genetics industry so far this year. The stock gained 8.9% compared to industry’s increase of 2.8% during the period.



The phase III 482 study compared Xgeva to Novartis AG’s (NYSE:NVS) Zometa (zoledronic acid). It, met the primary endpoint of analyzing the drugs’ non-inferiority in delaying the time to first on-study SRE in patients with multiple myeloma.

The secondary endpoints involved assessing the superiority of Xgeva versus zoledronic acid, regarding delaying the time to first on-study SRE as well as first-and-subsequent SRE of the study.

The overall survival (OS) was in favour of Xgeva, albeit statistically insignificant. While the progression-free survival (PFS) rate improved by 10.7 months, when treated with Xgeva versus Zometa.

In a separate press release, the company had announced positive results from a phase II study of its marketed drug Imlygic (talimogene laherparepvec) in combination with Bristol-Myers Squibb Company’s (NYSE:BMY) Yervoy (ipilimumab) for treating patients with unresectable stage IIIB-IV melanoma (skin cancer). The results were presented at the annual meeting of ASCO.

Imlygic is already approved by FDA for local treatment of unresectable cutaneous, subcutaneous and nodal lesions in patients with melanoma, recurrent after initial surgery.

The phase II 264 study met its primary end points and demonstrated a higher objective response rate for the combination therapy. Data showed that 38.8% of patients treated with combination of Imlygic and Yervoy, achieved an objective response compared to 18% of patients treated with Yervoy alone.

Per the company’s press release, myeloma is the second most common hematologic cancer, affecting nearly 114,000 new patients worldwide and causing 80,000 deaths every year. Whereas, patients with melanoma has drastically increased in the past 40 years, with 132,000 cases annually occurring worldwide. Hence, there is a huge potential market opportunity for the company to tap into and address the unmet needs of patients in both areas.

Zacks Rank & Key Picks

Amgen currently carries a Zacks Rank #3 (Hold). A better-ranked stock in healthcare sector includes VIVUS, Inc. (NASDAQ:VVUS) , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

VIVUS’s loss per share estimates lessened from 50 cents to 39 cents for 2017 in last 30 days. The company posted positive earnings surprises in all four trailing quarters with average beat of 233.69%.

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