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Positive Data on Amgen Candidate

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Amgen (AMGN) recently presented encouraging top-line results on its oncology candidate, talimogene laherparepvec, from a phase III study. The candidate is being developed for the treatment of melanoma, which is considered the most aggressive and serious form of skin cancer.

The global, randomized, open-label phase III study was conducted to evaluate the efficacy and safety of talimogene laherparepvec for the treatment of unresected stage IIIB, IIIC or IV melanoma compared to subcutaneous granulocyte-macrophage colony-stimulating factor (GM-CSF).

Preliminary results showed that talimogene laherparepvec met the primary endpoint of durable response rate (DRR). Amgen said that DRR was 16% in the talimogene laherparepvec arm compared to 2% in the GM-CSF arm. As far as overall survival (:OS) is concerned, data should be available later this year as it is an event driven endpoint. However, Amgen said that a pre-planned interim analysis indicates that the OS trend is in favor of talimogene laherparepvec compared to GM-CSF.

Frequently observed adverse events included fatigue, chills and pyrexia. Common serious adverse events included disease progression, cellulitis and pyrexia.

Our Take

The positive top-line data is encouraging as talimogene laherparepvec has always been viewed as a high-risk candidate. However, we believe that talimogene laherparepvec’s approval and market potential depends on the overall survival data which will be out later this year. Currently approved treatments include Bristol-Myers Squibbs’ (BMY) Yervoy and Roche’s (RHHBY) Zelboraf.

Meanwhile, Amgen intends to present additional safety and efficacy data from the study at the annual meeting of the American Society of Clinical Oncology (TATD).

Amgen currently carries a Zacks Rank #2 (Buy). 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.

Biotech company, Athersys, Inc. (ATHX), also looks well-positioned with a Zacks Rank #1 (Strong Buy).

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