Amgen 2009 Annual Report Download - page 50

mCRC. In this trial, Vectibix®significantly improved median PFS by 1.6 months (9.6 months versus 8.0 months
for patients treated with FOLFOX alone, (HR: 0.80; p=0.02)) in patients with KRAS wild-type mCRC (primary
endpoint). Further, the addition of Vectibix®to chemotherapy also increased the response rate in the KRAS wild-
type patient population as measured by blinded central review (55% versus 48% in the FOLFOX only arm).
Importantly, in patients with tumors harboring activating KRAS mutations, PFS was significantly inferior in the
Vectibix®arm. For patients with mutant KRAS tumors, median PFS was 7.3 months with Vectibix®in combina-
tion with FOLFOX versus 8.8 months with FOLFOX alone (HR: 1.29, p=0.02). These data confirm previous
findings when oxaliplatin-based chemotherapy and an anti-EGFr antibody are combined in patients bearing tu-
mors with activating KRAS mutations. Adverse event rates were comparable across arms with the exception of
known toxicities associated with anti-EGFr therapy such as rash, diarrhea and hypomagnesemia. Vectibix®-
related grade 3 infusion reactions were reported for two patients (less than 1%). Originally designed to compare
the treatment effect in the overall population, the study was amended to analyze outcomes with respect to the
presence or absence of activating mutations in KRAS in the tumor itself. Tumor KRAS status was ascertained in
93% of the 1,183 patients enrolled in the trial, the highest percentage ever reported. Tumor KRAS tests were
finalized after the completion of enrollment and prior to the primary analysis.
In November 2009, we announced that the phase 3 ‘203 trial evaluating Vectibix®administered in combina-
tion with FOLFOX (an oxaliplatin-based chemotherapy) as a first-line treatment of mCRC failed to meet a
secondary endpoint of OS. The prospective analysis of the ‘203 study showed that Vectibix®, when added to a
FOLFOX chemotherapy regimen in patients with KRAS wild-type mCRC, resulted in a median OS of 23.9
months compared to 19.7 months for patients treated with FOLFOX alone. The median OS difference of 4.2
months in the Vectibix®arm did not reach statistical significance (HR: 0.83, p=0.072). OS appeared to be re-
duced in patients with KRAS mutant tumors receiving Vectibix®. Although not statistically significant, this result
emphasizes the importance, as described in product labeling, of ensuring that patients receiving Vectibix®do not
bear tumors containing KRAS mutations.
In 2007, we initiated a phase 3 study for the first-line treatment of metastatic squamous cell carcinoma of
the head and neck (“SCCHN”) as well as two randomized phase 2 studies in locally advanced SCCHN testing
Vectibix®in combination with chemoradiotherapy or with radiotherapy alone. We expect the results from this
study to be available in 2010. Vectibix®is also being investigated in combination with other investigational anti-
cancer therapies.
Human Resources
As of December 31, 2009, we had approximately 17,200 staff members, which include approximately 200
part-time staff members. There can be no assurance that we will be able to continue attracting and retaining
qualified personnel in sufficient numbers to meet our needs. None of our staff members are covered by a collec-
tive bargaining agreement, and we have experienced no work stoppages. We consider our staff relations to be
good.
Trade secret protection for our unpatented confidential and proprietary information is important to us. To
protect our trade secrets, we generally require our staff members, material consultants and scientific advisors to
execute confidentiality agreements upon the commencement of employment or the consulting relationship with
us. However, others could either develop independently the same or similar information or obtain access to our
information.
Executive Officers of the Registrant
The executive officers of the Company as of January 31, 2010 are as follows:
Mr. Kevin W. Sharer, age 61, has served as a director of the Company since November 1992. Chief Execu-
tive Officer and President of the Company and has also been Chairman of the Board of Directors since January
2001. From October 1992 to May 2000, Mr. Sharer served as President and Chief Operating Officer of the Com-
pany. From April 1989 to October 1992, Mr. Sharer was President of the Business Markets Division of MCI
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