Amgen (AMGN) recently announced the presentation of planned interim data on Xgeva (denosumab) in the Lancet Oncology. Interim results were published from an international, open-label, phase II study evaluating Xgeva in adults and skeletally mature adolescents diagnosed with giant cell tumor of bone (:GCTB).
While the primary endpoint of the study is Xgeva’s safety profile, secondary endpoints include time to disease progression and the proportion of patients without any surgery at six months.
Amgen said that there was no disease progression in 96% of patients with surgically unsalvageable GCTB after a median follow-up of 13 months. Meanwhile, 74% of patients with salvageable GCTB whose surgery was associated with severe morbidity required no surgery and 62% of patients who had surgery underwent a less morbid procedure than expected.
In total, objective tumor response was observed in 72% of patients. As far as the overall safety profile is concerned, Amgen said that it was consistent with the known safety profile of Xgeva in patients with advanced cancer.
We note that the US Food and Drug Administration (:FDA) approved Xgeva for the treatment of GCTB that cannot be treated with surgery or when surgery can lead to severe morbidity in Jun 2013. Approval was granted for use in adults and skeletally mature adolescents.
Amgen had submitted its regulatory application in the US as well as the EU in Dec 2012. FDA approval was granted after a priority review was conducted.
Xgeva is currently approved for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. Xgeva sales came in at $748 million in 2012. Amgen has been working on expanding Xgeva’s label into additional indications.
Xgeva is in phase III studies for the delay or prevention of bone metastases in patients with adjuvant breast cancer and prevention of SRE in patients with multiple myeloma. Last year, Amgen had received a complete response letter (CRL) from the FDA for its supplemental biologics license application (sBLA) for Xgeva for the delay of bone metastases in prostate cancer.
While approval for the GCTB indication is a positive for the company, we believe the main potential for boosting Xgeva sales lies in gaining approval for the prevention of bone metastases in prostate and breast cancer patients.
Amgen currently carries a Zacks Rank #3 (Hold). Amgen should be able to deliver on its long-term strategy based on expansion in key markets, launch of new manufacturing technologies, and pipeline development. However, nearer-term, we remain concerned about the performance of existing products. We expect 2013 and 2014 to be important years for Amgen with results on several key pipeline candidates.
While Medivation and Sarepta are Zacks Rank #1 (Strong Buy) stocks, Aegerion is a Zacks Rank #2 (Buy) stock.
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