Amgen's Oncology Candidate Disappoints

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Amgen (AMGN) presented updated data on its oncology candidate, talimogene laherparepvec. The company, which had earlier presented encouraging top-line results, said that the candidate failed to meet the secondary endpoint of overall survival in a global, randomized, open-label phase III study.

The 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).

Amgen said that while the primary endpoint of durable response rate was achieved (16% in the talimogene laherparepvec arm compared to 2% in the GM-CSF arm), there was a strong trend in favor of talimogene laherparepvec where the secondary endpoint of overall survival was concerned even though the same was not achieved.

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

Our Take

Although talimogene laherparepvec met the primary endpoint, the failure to achieve overall survival is disappointing. Encouraging overall survival data would have boosted the candidate’s commercial potential, especially as a monotherapy.

We note that Amgen is studying talimogene laherparepvec in combination with Yervoy in a phase Ib study. Amgen also has an agreement with Merck (MRK) under which talimogene laherparepvec will be evaluated in combination with Merck’s investigational anti-PD-1 immunotherapy, MK-3475, in a phase Ib/II study in patients with mid- to late-stage melanoma.

Amgen is a Zacks Rank #2 (Buy) stock. Some better-ranked stocks in the biotech sector include companies like Alkermes plc (ALKS) and Gilead Sciences Inc. (GILD). Both are Zacks Rank #1 (Strong Buy) stocks.

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