The European Organisation for Research and Treatment of Cancer (EORTC) and health and beauty care company, Pierre Fabre, have begun a phase 3 study to assess a combination therapy for patients with stage 2 BRAF-mutant melanoma.
Melanoma develops through unrepaired DNA damage to skin cells, which triggers mutations that can multiply and form malignant tumours.
It is estimated that around 324,000 new cases of melanoma are diagnosed globally each year, with approximately half being BRAF mutations, a key target in the treatment of metastatic melanoma.
Although considerable progress has been made in treating advanced melanoma activating the BRAF mutation, there still remains a high unmet need in earlier stages of the disease. It is estimated that around 18% of stage 2B and 25% of stage 2C patients die from melanoma within ten years of diagnosis.
The study – COLUMBUS-AD – will assess whether the combination of BRAF and MEK inhibitors Braftovi (encorafenib) and Mektovi (binimetinib) can prolong recurrence-free survival (RFS) and improve distant metastasis-free survival (DMFS) and overall survival (OS) as compared to placebo in participants with surgically resected stage 2B-C BRAF V600E/K-mutant cutaneous melanoma.
The COLUMBUS-AD study will enrol over 800 patients, beginning in April 2022, with 160 sites in up to 25 countries internationally taking part. Patients involved in the study will have had surgery for a stage 2B-C melanoma with a BRAF V600E/K mutation and must have made a full recovery from the surgery.
Patients will receive Braftovi and Mektovi or placebo for up to 12 months and will have a monthly follow-up during the treatment period, and then every three months up to year three. Further follow-ups will then happen regular intervals, with patient follow-ups continuing for ten years.
“Pierre Fabre’s partnership with EORTC is now accelerating with the opening of COLUMBUS-AD”, said Dr Deborah Szafir, executive vice president, head of medical and patient consumer division at Pierre Fabre.
“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.”
Results for the primary endpoint (Recurrence Free Survival) are expected by 2027 and Overall Survival results should be released by 2035.