CASTRES, France<\/span> and BRUSSELS<\/span>, May 24, 2022<\/span> \/PRNewswire\/ — Pierre Fabre and the European Organisation for Research and Treatment of Cancer (EORTC) today announced the screening of the first patient with a resected stage II BRAF<\/i>-mutant melanoma for the phase III study COLUMBUS-AD (NCT05270044; EORTC-2139-MG).<\/p>\n

COLUMBUS-AD is a pioneering study to evaluate whether the combination of BRAF and MEK inhibitors encorafenib (Braftovi^{®<\/sup>) and binimetinib (Mektovi^{®<\/sup>) 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 IIB-C BRAF V600E\/K-mutant cutaneous melanoma.<\/p>\n}}

"Pierre Fabre’s partnership with EORTC is now accelerating with the opening of COLUMBUS-AD", said Dr Deborah Szafir<\/span>, 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."<\/p>\n

Approximately 815 patients will be enrolled in COLUMBUS-AD. More than 160 sites in up to 25 countries worldwide will participate in the study.<\/p>\n

Despite the remarkable progress made in the treatment of advanced melanoma activating the BRAF mutation, unfortunately there remains a high unmet need in earlier stages of the disease. It is estimated that 18% of stage IIB and 25% of stage IIC patients die from melanoma within 10 years from diagnosis.<\/p>\n

"The screening of patients for COLUMBUS-AD focuses on patients with surgically resected high-risk IIB-C BRAF<\/i> V600E\/K-mutant cutaneous melanoma", said study coordinator assoc. prof. Dr. Alexander C.J. 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".<\/p>\n

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.<\/p>\n

Patients will receive encorafenib and binimetinib or placebo for up to 12 months. They will be followed-up monthly during the treatment period, then every 3 months up to year 3, and then at regular intervals. The participants will be followed-up for 10 years in total.<\/p>\n

Pierre Fabre has a long-standing commitment to the melanoma community and takes a unique holistic approach to skin health with expertise in oncology, dermatology and dermo-cosmetics. EORTC, a unique academic clinical research organisation uniting clinical cancer research experts across the globe, shares Pierre Fabre’s commitment to improving the standard of cancer treatment for patients.<\/p>\n

Melanoma develops when unrepaired DNA damage to skin cells triggers mutations that may lead them to multiply and form malignant tumours.^{1<\/sup> There are about 324,000 new cases of melanoma diagnosed worldwide each year, approximately half of which have BRAF mutations, a key target in the treatment of metastatic melanoma.^{2,3,4 <\/sup>By 2025, the number of cases is expected to increase to over 340,000.^{5<\/sup><\/p>\n}}}

The European Organisation for Research and Treatment of Cancer (EORTC) is a non-governmental, non-profit organisation, which unites clinical cancer research experts, throughout Europe<\/span>, to define better treatments for cancer patients to prolong survival and improve quality of life. Spanning from translational to large, prospective, multi-centre, phase III clinical trials that evaluate new therapies and treatment strategies as well as patient quality of life, its activities are coordinated from EORTC Headquarters, a unique international clinical research infrastructure, based in Brussels, Belgium<\/span>.<\/p>\n

\n\n\n\n\n\n
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EORTC <\/b> <\/span><\/p>\n<\/td>\n
\n
Pierre Fabre<\/b><\/span><\/p>\n<\/td>\n<\/tr>\n
\n
Isabelle GAUTHEROT <\/span><\/p>\n<\/td>\n
\n
Laure SGANDURRA<\/span><\/p>\n<\/td>\n<\/tr>\n
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communication@eortc.org <\/span><\/p>\n<\/td>\n
\n
laure.sgandurra@pierre-fabre.com<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n
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