Pierre Fabre and the European Organisation for Research and Treatment of Cancer (EORTC) have screened the first subject in the Phase III COLUMBUS-AD clinical trial of encorafenib (Braftovi) and binimetinib (Mektovi) in resected stage II BRAF-mutant melanoma patients.
An oral small-molecule inhibitor of MEK, binimetinib acts on key enzymes in the MAPK signalling pathway (RAS-RAF-MEK-ERK). Encorafenib is an oral small-molecule inhibitor of BRAF kinase.
Pierre Fabre holds exclusive rights for the development and marketing of Braftovi and Mektovi globally, excluding some markets.
Sponsored by Pierre Fabre, the trial will analyse if the encorafenib and binimetinib combination treatment can extend recurrence-free survival (RFS) and enhance distant metastasis-free survival (DMFS) and overall survival (OS) versus placebo.
The trial will enrol nearly 815 subjects with surgically resected stage IIB-C BRAF V600E/K-mutant cutaneous melanoma.
Over 160 sites in up to 25 countries across the globe will take part in the trial.
In the trial, subjects will be given encorafenib plus binimetinib or a placebo for up to 12 months.
Furthermore, these participants will be followed up every three months for up to three years and subsequently at particular intervals following the treatment.
In total, the company intends to follow up on the trial subjects for ten years.
Pierre Fabre Medical and Patient Consumer Division head, executive vice-president Dr Deborah Szafir said: “Pierre Fabre’s partnership with EORTC is now accelerating with the opening of COLUMBUS-AD.
“Building on the clinical benefits that our medicines have demonstrated in advanced disease, we are eager for patients with a BRAF-mutated tumour to explore the adjuvant setting in an earlier stage of the disease as the unmet medical need remains high.”