Biotech company Amgen (AMGN) recently reported disappointing results on its oncology drug, Vectibix, which was being studied for the first-line treatment of head and neck cancer. Top-line results from a randomized phase III study showed that Vectibix failed to achieve its primary endpoint. Although treatment with Vectibix plus platinum-based chemotherapy prolonged the medial survival period to 11.1 months compared to 9 months with chemotherapy alone, the improvement in overall survival was not statistically significant. As far as secondary endpoints were concerned, the Vectibix arm showed improvement in progression free survival (5.8 months versus 4.6 months) and objective response rate (36% versus 25%). However, the results were not tested for statistical significance. Full data will be presented in early October. Vectibix’ failure in the head and neck cancer trial is a disappointment for Amgen. Although Vectibix is currently approved for the treatment of colorectal cancer, Amgen is looking to drive product sales by gaining approval for additional indications. Vectibix sales came in at $72 million during the second quarter of 2010. The product competes primarily with Eli Lilly (LLY)/Bristol-Myers Squibb's (BMY) Erbitux. Approval for the oral head and neck cancer indication would have given a nice boost to Vectibix sales. According to the company, oral head and neck cancer is the sixth most common cancer in the world. It is estimated that about 400,000 new cases are detected annually.Our Take While we view the disappointing results on Vectibix as a setback for Amgen, we believe that investor focus is primarily on Prolia. Amgen is scheduled to report data on Prolia from a phase III study (147) conducted on patients with prostate cancer. Moreover, Amgen is looking to get Prolia approved for delaying skeletal related events in patients with advanced cancer. A response from the US Food and Drug Administration (FDA) on Prolia’s approvability should be out by November 18, 2010. We currently have a Neutral recommendation on Amgen, which is supported by a Zacks # 3 Rank (Hold).
updated Aug 12, 2010
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