
We performed a biomarker analysis which indicated that in mCRC patients who have failed all other chemotherapeutic regimens, the efficacy of Vectibix™ monotherapy is confined to patients with non-mutated (wild-type) KRAS tumors. Specifically, in patients with non-mutated KRAS tumors, Vectibix significantly increased PFS and had an impact on quality of life and disease-related symptoms, compared to best supportive care alone. Indeed, patients whose tumors contained these mutations did not seem to benefit from Vectibix™ treatment. As a result of our KRAS analyses, we have amended the protocols of our ongoing phase 3 studies for the treatment of first-line and second-line mCRC that were initiated in 2006 to test the effects of adding Vectibix™ to chemotherapy according to KRAS status. In January 2008, we disclosed interim safety results from our first- and second-line studies in mCRC. The independent Data Monitoring Committee's reviews of the pooled safety data from both arms of these trials recommended the studies continue per protocol. Our phase 2 studies in first- and second-line CRC initiated in 2006 (STEPP, SPIRTT, PRECEPT) are ongoing.
In 2007, we initiated a phase 3 study for the first-line treatment of metastatic head and neck cancer (“SCCHN”) as well as two randomized phase 2 studies in locally advanced SCCHN testing Vectibix™ in combination with chemoradiotherapy or with radiotherapy alone. Vectibix™ is also being investigated in combination with other investigational anti-cancer therapies.
This information is current as of February 27, 2008. Amgen’s product pipeline will change over time as molecules move through the drug development process, including progressing to market or failing in clinical trials, due to the nature of the development process. This description contains forward-looking statements that involve significant risks and uncertainties, including those discussed in Amgen’s most recent Form 10-K and in Amgen’s periodic reports on Form 10-Q and Form 8-K, and actual results may vary materially. Amgen is providing this information as of the date above and does not undertake any obligation to update any forward-looking statements contained in this table as a result of new information, future events or otherwise.