Merck
Serono, the biopharmaceutical division of Merck, 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,1,2who 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.
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.
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.
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