Merck 2010 Annual Report Download - page 63

The clinical hold was put in place by the FDA in March 2010 following a suspected unexpected
serious adverse reaction. A patient participating in a Phase II exploratory clinical trial with the
cancer immunotherapy in multiple myeloma developed encephalitis. Since 2007, we have been
conducting the START trial to evaluate the efficacy and safety of the treatment with Stimuvax ®
in patients with inoperable stage III non-small cell lung cancer. The decision to initiate this
trial was based on the results of a randomized Phase IIb study, in which Stimuvax ® showed
an increase in overall survival of a subset of patients with locoregional stage IIIb NSCLC from
13.3 months in the control group to 30.6 months in the treatment group. In 2009, we initiated
INSPIRE, a Phase III trial in NSCLC in Asia. Should the Phase III trials be successfully completed,
this cancer immunotherapy could play an important role in the treatment of lung cancer
patients, for whom current therapeutic options are still limited.

Cilengitide is the first integrin inhibitor in oncology to have entered Phase III clinical develop-
ment. In the CENTRIC trial, we are studying this compound in glioblastoma (GBM), the most
aggressive type of brain tumor. Integrin inhibitors are thought to work by targeting tumor
cells and the vascular network required to nourish the tumor and promote cancer cell growth.
Long-term follow-up data from a randomized Phase II study of two different cilengitide doses
in recurrent glioblastoma were published in 2010. They showed that 37% of patients who
received the higher dose of cilengitide (2000 mg) were still alive after one year. The current
prognosis of patients with recurrent glioblastoma is poor with median overall survival between
four and seven months and one-year survival rates of approximately 20%.

Merck Serono remains committed to its discovery and development work in the therapeutic
area of oncology. Our aim is to offer patients with high unmet medical needs additional
therapeutic options in various indications. An important step toward this aim is the worldwide
research and development agreement entered into with Sanofi-Aventis at the end of 2010. This
agreement allows the experimental combination of Merck’s MEK inhibitor with one of two early
compounds of the partner, respectively.
We are currently investigating three compounds in Phase I studies in solid tumors and hema-
tological diseases. In addition, five Phase II studies are underway in breast, head and neck,
non-small cell lung as well as colorectal cancer.
Since our pipeline includes numerous compounds with high therapeutic potential, we remain
committed to moving forward those projects with the greatest promise of sustainable success.
At the same time, we will terminate or divest at an early stage those projects that appear
to be less promising. This enables us to ensure that our resources are deployed to benefit
patients and to manage the risks for our company. In 2010, we terminated the following
four early-stage oncology projects: an aurora-kinase inhibitor and the monoclonal antibody
sonepcizumab in Phase I; the immunocytokine tucotuzomab celmoleukin and the monoclonal
antibody adecatumumab in Phase II.
Merck Serono remains highly
committed to research and
development in oncology
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