Merck Serono Initiates Phase II Study of Anti-PD-L1 Antibody MSB0010718C in Metastatic Merkel Cell Carcinoma
Merck Serono Initiates Phase II Study of Anti-PD-L1 Antibody MSB0010718C in Metastatic Merkel Cell Carcinoma
PR57467
DARMSTADT, Germany, Jul 29, 2014 /PRN=KYODO JBN/ --
- 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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SOURCE: Merck Serono
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