EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, has announced the beginning of an international Phase II multi-center, international, single-arm, open-label clinical trial, designed to evaluate the efficacy and safety of its experimental drug MSB0010718C in subjects with metastatic Merkel cell carcinoma (MCC) who must have received one line of chemotherapy for the treatment of metastatic MCC.
MCC, or neuroendocrine carcinoma, is a rare and aggressive disease that tends to metastasize at an early stage. It is characterized by the accumulation of cancer cells in the top layer of the skin, especially in areas commonly exposed to the sun, such as head, neck, arms and legs. In addition to the sun, other risk factors include a compromised immune system, for example patients who have received organ transplants, suffering from HIV/AIDS or from other types of cancers, the presence of the Merkel cell polyomavirus, which can participate in tumor formation.
The incidence of MCC has been increasing over the years, and satisfactory outcomes for patients are very poor.
Currently, treatment for MCC includes surgery, radiation, and chemotherapy; however, the need for new treatment approaches has led to the development of clinical trials exploring the potential of immune checkpoint inhibitors, such as those targeting CTLA-4 or PD-1. As such, MSB0010718C is a human IgG1 monoclonal antibody that binds to the programmed death-ligand 1 (PD-L1), a protein expressed at high levels at the surface of several types of cancer that plays a major role in suppressing the immune system. MSB0010718C can block the interaction of PD-L1 with its receptors, this way restoring anti-tumor T-cell responses.
This study is expected to recruit patients across Asia Pacific, Australia, Europe, and North America, and has set its primary endpoint as best overall response, and secondary outcomes as duration of response, progression-free survival and overall survival up to 3 years, in addition to treatment adverse side events.
“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 the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, in a EMD Serono press release. “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 a complementary study, MSB0010718C is also being tested in a Phase I clinical trial for the treatment of solid tumors, and is currently recruiting patients that suffer from castrate-resistant prostate cancer, colorectal cancer, gastric/gastroesophogeal cancer, melanoma, metastatic breast cancer, non-small cell lung cancer and ovarian cancer.