EMD Serono begins MSB0010718C Phase II study in patients MMCC

EMD Serono begins MSB0010718C Phase II study in patients MMCC -

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, today announced the opening of an international Phase II study to evaluate the efficacy and safety of MSB0010718C, a monoclonal antibody fully human IgG1 experimental that binds to the programmed death ligand-1 (PD-L1). This multicenter, single-arm, open-label study was conducted in patients with metastatic carcinoma Merkel cell (MMCC), a rare and aggressive type of tumor of the skin, which have already received chemotherapy line . It is planned to recruit 84 patients across Asia Pacific, Australia, Europe and North America. The primary endpoint of the study is the overall response.

The PD-L1 / PD-1 pathway is involved as the main mechanism by which tumors escape elimination by the immune system. PD-L1 molecule is expressed in many types of cancer, including MMCC. MSB0010718C, which blocks the PD-L1 interaction with the PD-1 receptor, may have the potential to restore effective antitumor T cell responses and therefore inhibit tumor growth.

The immune mechanisms involved in the pathogenesis of MCC, with an increased risk observed in immunocompromised individuals. CMC is also associated with the presence of Merkel cell polyomavirus, which may have a role in tumor formation. Globally, the incidence of MCC is increasing, and outcomes for patients with this disease are poor. Therefore, new treatment approaches are needed to improve outcomes for patients with this type of cancer.

"We believe that the modulation of the immune system by targeting PD-L1 represents a promising new approach in the treatment of this aggressive cancer, especially since many of the predisposing factors for MMCC seem to be related to functional disturbances of the immune system, "said Helen Sabzevari, Senior Vice President of Immuno-oncology at the biopharmaceutical division of Merck KGaA, Darmstadt, Germany." Our anti-PD-L1 compound may present a potential new approach for treating MMCC patients. The initiation of this Phase II study is an important step, as we strive to help those who suffer 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 50 patients and 422 patients recruited to date. On 1 June 2014, EMD Serono presented initial data from this dose escalation study in solid tumors at the annual American Society of Clinical Oncology meeting (ASCO) in Chicago. This study is currently enrolling patients in the expansion cohort in seven types of cancer. Castrate resistant prostate cancer, colorectal cancer, gastric / gastroesophogeal cancer, melanoma, breast cancer metastatic cancer non-small cell lung and ovarian cancer