Country for PR: United Kingdom
Contributor: PR Newswire Europe
Wednesday, May 25 2022 - 16:15
Pierre Fabre and EORTC open a large Phase III clinical study in the adjuvant setting of stage IIB-C melanoma
CASTRES, France and BRUSSELS, May 24, 2022 /PRNewswire-AsiaNet/ --

- First study conducted in the adjuvant setting with a combination of BRAF and 
MEK inhibitors in high-risk stage II BRAF V600E/K-mutant cutaneous melanoma
- A global partnership between EORTC and Pierre Fabre to advance research in 

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-mutant melanoma for the phase III study COLUMBUS-AD (NCT05270044; 

COLUMBUS-AD is a pioneering study to evaluate whether the combination of BRAF 
and MEK inhibitors encorafenib (Braftovi(R)) and binimetinib (Mektovi(R)) 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 

"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."

Approximately 815 patients will be enrolled in COLUMBUS-AD. More than 160 sites 
in up to 25 countries worldwide will participate in the study.

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.

"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 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 

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 

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.

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 

About Melanoma
Melanoma develops when unrepaired DNA damage to skin cells triggers mutations 
that may lead them to multiply and form malignant tumours.[1] 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] By 2025, the number of cases is expected to increase to 
over 340,000.[5]

About the EORTC 
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, 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.

For further information, please visit the EORTC website:
About encorafenib (Braftovi(R)) and binimetinib (Mektovi(R))

Encorafenib is an oral small-molecule BRAF kinase inhibitor and binimetinib is 
an oral small-molecule MEK inhibitor that targets key enzymes in the MAPK 
signalling pathway (RAS-RAF-MEK-ERK). Inappropriate activation of proteins in 
this pathway has been shown to occur in many cancers, including melanoma, 
colorectal cancer, non-small-cell lung cancer, thyroid and others.

Pierre Fabre has exclusive rights to develop and commercialise Braftovi(R) and 
Mektovi(R) worldwide, except in the US and Canada, where Pfizer (Array 
BioPharma) retains exclusive rights; Israel, where Medison has exclusive 
rights; Japan and South Korea, where Ono Pharmaceutical has exclusive rights to 
commercialise both products; and Latin America, Africa and Middle East where 
both products have been sub-licensed to Pfizer.

Pierre Fabre is the sponsor of the COLUMBUS-AD Phase III study. The overall 
development of Braftovi(R) and Mektovi(R) is driven in partnership with Pfizer 
in diverse indications.

About Pierre Fabre Oncology
The Pierre Fabre Group is the second largest private French healthcare group 
and the second largest dermo-cosmetics manufacturer in the world. In 2021, it 
generated €2.5 billion in revenues, 66% of which came from international sales. 
Pierre Fabre employs some 9500 people worldwide and manufactures over 95% of 
its products in France. Its portfolio includes several medical franchises and 
international brands, including Pierre Fabre Oncology, Pierre Fabre 
Dermatology, Eau Thermale Avene, Klorane, Ducray, Rene Furterer, A-Derma and 
Pierre Fabre Oral Care.

In oncology, Pierre Fabre enjoys over 35 years of experience in discovery, 
development, manufacturing and marketing, with a portfolio of therapies 
covering colorectal, breast, lung cancers, melanoma and pre-cancerous 
conditions such as actinic keratosis. Pierre Fabre's innovation and 
commercialization efforts in oncology are focused on targeted therapies, 
biotherapies and immuno-oncology.

The Pierre Fabre Group is 86%-owned by the Pierre Fabre Foundation, a 
public-interest foundation, and secondarily by its own employees through an 
international employee stock ownership plan.

Further information about Pierre Fabre can be found at, 

[1] Neoplasma. 2016;63(4):510-7. doi: 10.4149/neo_2016_403. 
[2] American Cancer Society. What Causes Melanoma Skin Cancer. Available at: 
Accessed May 2021.
[3] International Agency for Research on Cancer. Melanoma of skin. Available 
Accessed May 2021.
[4] Klein O, et al. Eur J Cancer 2013;49:1073–1079.
[5] Melanoma UK. 2020 Melanoma Skin Cancer Report. Available at: 2020 MELANOMA 
SKIN CANCER REPORT | Melanoma UK. Accessed May 2021. 

EORTC                            Pierre Fabre
Isabelle GAUTHEROT               Laure SGANDURRA
Photo -

Source : Pierre Fabre