) 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
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
) Yervoy and
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
), also looks well-positioned with a Zacks Rank #1 (Strong Buy).
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