First patient enrolled in melanoma study
pharmafile | May 24, 2022 | News story | Manufacturing and Production |
Pierre Fabre and the European Organisation for Research and Treatment of Cancer (EORTC) have announced the screening of the first patient with a resected stage II BRAF-mutant melanoma for the Phase III study COLUMBUS-AD.
The study is the first with targeted therapy conducted in the adjuvant setting, to evaluate whether the combination of encorafenib and binimetinib can decrease risk for recurrence (RFS), and improve distant metastasis-free survival (DMFS) and overall survival (OS), versus surveillance follow-up in participants with surgically resected high-risk IIB/C BRAF V600E/K-mutant cutaneous melanoma.
The study will enrol approximately 815 patients across over 160 sites and up to 25 countries worldwide.
“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.”
Patients included in the study must have undergone resection of a stage IIB-C melanoma with a BRAF V600E/K mutation, confirmed on resected tumour sample by a central laboratory, and a negative result on sentinel node biopsy. Patients must also have fully recovered from the surgery, have a good performance status (ECOG 0/1), and adequate hematologic, hepatic, cardiac, coagulation and renal functions.
“The screening of patients for COLUMBUS-AD focuses on patients with surgically resected high-risk IIB-C BRAF V600E/K-mutant cutaneous melanoma”, said study coordinator associate professor Dr Alexander CJ Van Akkooi, MD PhD, from the Melanoma Institute Australia (MIA) and past chairman of the EORTC Melanoma Group. “It is essential to test the tumour as early as possible for BRAF mutation, so that eligible patients can get a chance to participate into COLUMBUS-AD”.
