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Amgen ( AMGN - Analyst Report ) 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.
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 - Analyst Report ) 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 (ASCO).
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.
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