Merck Serono Initiates Phase II Study of Anti-PD-L1 Antibody MSB0010718C in Metastatic Merkel Cell Carcinoma

Darmstadt, Germany (ots/PRNewswire) -

- First patient begins treatment in an international Phase II study
investigating the efficacy and safety of MSB0010718C in patients with metastatic
Merkel cell carcinoma (mMCC)
- mMCC is a rare and aggressive skin cancer lacking effective treatments
- MSB0010718C is also currently being explored in a seven cohort Phase I
clinical trial for the treatment of solid tumors that aims to recruit 590 patients

Merck Serono, the biopharmaceutical division of Merck, today
announced the initiation of an international Phase II study designed
to assess the efficacy and safety of MSB0010718C, an investigational
fully human IgG1 monoclonal antibody that binds to programmed
death-ligand 1 (PD-L1). This multicenter, single-arm, open-label
study is being conducted in patients with metastatic Merkel cell
carcinoma (mMCC), a rare and aggressive type of skin tumor,[1],[2]
who have previously received one line of chemotherapy. It is expected
to recruit 84 patients across Asia Pacific, Australia, Europe and
North America. The primary endpoint of the study is overall response.

The PD-L1/PD-1 pathway is implicated as a major mechanism by which
tumors evade elimination by the immune system.[3] The PD-L1 molecule
is expressed in many cancer types, including mMCC.[3],[4]
MSB0010718C, which blocks the interaction of PD-L1 with its receptor
PD-1, may have the potential to restore effective anti-tumor T-cell
responses and thereby to inhibit tumor growth.

Immune mechanisms are implicated in the pathogenesis of MCC, with
an increased risk observed in immunosuppressed individuals.[5] MCC
also is associated with the presence of the Merkel cell polyomavirus,
which may have a role in tumor formation.[6] Globally, the incidence
of MCC is increasing, and outcomes for patients with this disease are
poor.[1],[2] Therefore, new treatment approaches are required to
improve the outcome of patients with this type of cancer.

"We believe that modulating the immune system by targeting PD-L1
represents a promising new approach in the treatment of this
aggressive cancer, especially considering that many of the
predisposing factors for mMCC seem to be related to functional
disruptions of the immune system," said Helen Sabzevari, Senior Vice
President of Immuno-Oncology at Merck Serono. "Our anti-PD-L1
compound may present a potential new approach for the treatment of
mMCC patients. The initiation of this Phase II study is an important
milestone, as we endeavor to help those suffering from mMCC, a
devastating disease with significant unmet need."

In addition to this new study in mMCC, MSB0010718C is currently
being explored in a Phase I clinical trial for the treatment of solid
tumors. The study aims to recruit 590 patients and has enrolled 422
patients to date. On June 1, 2014, Merck Serono presented initial
data from this dose escalation study in solid tumors at the annual
American Society of Clinical Oncology (ASCO) meeting in Chicago.[7]
This study is currently recruiting patients into expansion cohorts in
seven cancer types: castrate-resistant prostate cancer, colorectal
cancer, gastric/gastroesophageal cancer, melanoma, metastatic breast
cancer, non-small cell lung cancer and ovarian cancer.

References

1) Hughes MP, et al. Curr Dermatol Rep 2014;3:46-53.
2) Kaae J, et al. J Natl Cancer Inst 2010;102(11):793-801.
3) Lipson EJ, et al. Cancer Immunol Res 2013;1(1):54-63.
4) McDermott DF and Atkins MB. Cancer Med 2013; 2(5):662-73.
5) Bhatia S, et al. Curr Oncol Rep 2011;13(6):488-97.
6) Feng H, et al. Science 2008;319(5866):1096-100.
7) Heery CR, et al. J Clin Oncol 2014;32:5(Suppl.) Abstract No. 3064.

About MSB0010718C

MSB0010718C is an investigational fully human IgG1 monoclonal
antibody that binds to the PD-L1 (programmed death-ligand 1) protein,
which is present at high levels in many cancer types. By
competitively blocking the interaction with PD-1 receptors, it is
believed that MSB0010718C thereby restores anti-tumor T-cell
responses.

About Merkel cell carcinoma (MCC)

MCC is a rare and aggressive disease in which cancer cells form in
the top layer of the skin, close to nerve endings. MCC, which is also
known as neuroendocrine carcinoma of the skin or trabecular cancer,
often starts in those areas of skin that are most often exposed to
the sun, including the head and neck, arms, legs, and trunk. Risk
factors for MCC include sun exposure and having a weak immune system
(i.e., solid-organ transplant recipients, people with HIV/AIDS and
people with other cancers, such as chronic lymphocytic leukemia, are
at higher risk). Caucasian males over age 50 are at increased risk.

MCC tends to metastasize at an early stage, spreading initially to
nearby lymph nodes, and then potentially to more distant areas in the
body, including other lymph nodes or areas of skin, lungs, brain,
bones, or other organs.

Current treatment options for MCC include surgery, radiation and
chemotherapy. Treatment for metastatic or Stage IV MCC is generally
palliative.

About Merck Serono

Merck Serono is the biopharmaceutical division of Merck. With
headquarters in Darmstadt, Germany, Merck Serono offers leading
brands in 150 countries to help patients with cancer, multiple
sclerosis, infertility, endocrine and metabolic disorders as well as
cardiovascular diseases. In the United States and Canada, EMD Serono
operates as a separately incorporated subsidiary of Merck Serono.

Merck Serono discovers, develops, manufactures and markets
prescription medicines of both chemical and biological origin in
specialist indications. We have an enduring commitment to deliver
novel therapies in our core focus areas of neurology, oncology,
immuno-oncology and immunology.

For more information, please visit http://www.merckserono.com.

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