Merck 2010 Annual Report Download - page 62

for Experimental Neurology (INSPE) and the Department of Neurology at the San Raffaele
Scientific Institute in Milan, Italy. The aim of the cooperation is to advance clinical research
projects in the field of neurodegenerative diseases using new models and technologies.
Merck Serono Ventures is the name of our corporate venture capital fund. In 2010, the fund
invested in two highly innovative biotech companies. One of the companies is f-Star from
Vienna, Austria, which is engaged in the discovery and development of modified antibodies.
The most recent investment was made in Auxogyn of San Francisco. This company is develop-
ing a non-invasive tool for early assessment of embryo viability within the scope of in vitro
fertilization procedures.
Additionally, internal cooperation with Merck Millipore is creating new prospects. Potential
synergies exist in areas such as companion diagnostics, systems biology, new biopharmaceutical
drug delivery methods, and in the search for new routes in biopharmaceutical production.

Further analysis of the Phase III CRYSTAL trial once again confirmed the therapeutic value of
Erbitux ®. New data show that patients with KRAS wild-type metastatic colorectal cancer (mCRC)
who experienced early tumor shrinkage during first-line Erbitux ®-based treatment had an
unprecedented overall median survival of 28.3 months. Further Phase III studies are being
conducted in gastric cancer (EXPAND) and adjuvant colorectal cancer (PETACC-8).
Initial results of the randomized Phase II trial BALI-1 demonstrated the therapeutic potential of
Erbitux ® in breast cancer. Treatment with Erbitux ® in combination with chemotherapy showed
positive results in patients with metastatic triple-negative breast cancer (TNBC). Median pro-
gression-free survival in women treated with Erbitux ® plus chemotherapy more than doubled.
Although tumor response nearly doubled, the primary endpoint of the study, response rate,
was not met. TNBC is aggressive, difficult to treat, and associated with high rates of metastasis
and relapse.
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In June, Merck resumed the Stimuvax ® (BLP25 liposome vaccine) clinical program in patients
with non-small cell lung cancer (NSCLC), which includes the Phase III studies START and INSPIRE.
The treatment and enrollment of patients has restarted after approval by the local regulatory
authorities and ethics committees. This was made possible by a decision by the U.S. Food and
Drug Administration (FDA) to partially lift the clinical hold and allow the START trial to resume.
The Phase III STRIDE trial in advanced breast cancer was the study that remained on clinical hold
by the FDA. Merck Serono decided to close this study.
New data on Erbitux ® for
first-line treatment of metastatic
colorectal cancer
Merck Annual Report 2010 58