Real-world clinical data on combination therapy with binimetinib and encorafenib for malignant melanoma

Malignant melanoma, also known as black skin cancer, is a particularly dangerous form of skin cancer because it can grow rapidly and spread throughout the body. In the early stages, survival rates for patients are very good, and the tumor is completely removed surgically. However, the cancer is usually no longer operable if it has already spread to other organs or lymph nodes (metastasized), is too large, or is located in a difficult-to-reach area. In these cases, survival rates are significantly lower.

Thanks to new medications and detailed analyses of the cancer cells, however, prognoses have already improved significantly in recent years. For example, about half of all advanced melanomas have what is known as a BRAF mutation. This is a change in the cancer cells that accelerates their growth. At the same time, however, it is also a target for drugs known as BRAF inhibitors, such as encorafenib. MEK inhibitors, such as the drug binimetinib, also block proteins in this signaling pathway that are responsible for the uncontrolled growth of cancer cells. These two classes of drugs are combined because they are more effective together, help prevent resistance, and often result in fewer side effects than when a single drug is used alone. For this reason, this combination therapy is the standard of care for inoperable or metastatic melanoma with a BRAF mutation. In the current guidelines, in addition to the study drugs, other BRAF/MEK inhibitor combinations, as well as checkpoint inhibitors such as pembrolizumab, are approved and intended for treatment. The specific selection of drugs depends on many different factors. In most cases, these treatment approaches are not curative but focus on controlling symptoms and preventing disease progression.

The goal of the BERING study is to collect additional real-world data on the already approved drug combination of encorafenib (BRAF inhibitor) and binimetinib (MEK inhibitor). This is a purely observational study, and the decision to have patients receive this treatment regimen must have been made independently of this study. Data on disease progression, patients’ quality of life, and medication administration will be collected over a period of 12 to 90 months as part of the study. No new therapy is being tested in this study; all medications used are already approved.

Women and men aged 18 and older with inoperable or metastatic melanoma in which a BRAF mutation has been detected are eligible to participate in the study. A decision must have been made independently of this study that they should receive the treatment regimen being investigated here (encorafenib + binimetinib). The disease may have been treated with no more than one prior line of therapy, but not with chemotherapy or a BRAF/MEK inhibitor combination therapy, unless the combination therapy was discontinued more than 6 months before the start of the study medication.