Amgen 2007 Annual Report Download - page 31

The following text provides additional information about selected product candidates, by therapeutic area,
that are in human clinical trials.
Oncology
We utilize multiple strategies to develop oncology therapeutics. These approaches include developing prod-
ucts that: (i) kill highly proliferative cells, (ii) inhibit cancer cell nutrient supply and (iii) interdict growth control
and cell survival signals. Many of our oncology programs target numerous cancer types.
Vectibix™ (panitumumab)
Vectibix™ targets the EGFr. The EGFr pathway is important in normal and tumor cell growth, and dysregu-
lation of this pathway has been associated with cancer. EGFr is a proven target in oncology. Vectibix™ is a
fully-human monoclonal IgG2 antibody binding to the EGFr and is being evaluated for the treatment of various
types of cancer (solid tumors).
We performed a biomarker analysis which indicated that in mCRC patients who have failed all other chemo-
therapeutic 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 chemo-
therapy 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 combi-
nation with other investigational anti-cancer therapies.
AMG 102
AMG 102 is a fully human monoclonal antibody that targets the action of hepatocyte growth factor/scatter
factor (“HGF/SF”). HGF/SF signaling, through its receptor c-Met, appears to play an important role in many
types of human cancers. Phase 2 studies of AMG 102 initiated in 2006 as a potential cancer therapeutic for Renal
Cell Carcinoma (“RCC”) and Glioblastoma Multiforme (“GBM”) are ongoing.
AMG 386
AMG 386 is a recombinant Fc-peptide fusion protein (peptibody) targeting angiopoietins. AMG 386 is de-
signed to bind angiopoietins 1 and 2, thereby inhibiting Tie2 dependent stimulation of endothelial cells.
Angiopoietins, together with vascular endothelial growth factors (“VEGFs”), are key cytokines that regulate
neovascularization. In 2007, we initiated four phase 2 studies of AMG 386 for the treatment of RCC, metastatic
breast cancer, ovarian cancer and gastric cancer.
AMG 479
AMG 479 is a fully human monoclonal antibody that binds to insulin-like growth factor-1 receptor without
cross-reacting with the closely related insulin receptor. A phase 1 clinical study to evaluate the safety and toler-
ability of AMG 479 monotherapy is ongoing. Phase 1 combination studies with gemcitabine or panitumumab are
also ongoing. In 2007, we initiated a phase 2 study of AMG 479 as a potential cancer therapeutic in Ewing’s Sar-
coma.
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