A Treatment Option for Metastatic Colorectal Cancer Patients with BRAFV600E Mutation in Singapore

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About colorectal cancer

Worldwide, colorectal cancer is the third most common type of cancer in men and the second most common in women, with approximately 1.8 million new diagnoses in 2018. Globally in 2018, approximately 881,000 deaths were attributed to colorectal cancer.¹⁶ Every year more than 450,000 people in Europe are diagnosed with colorectal cancer and approximately 230,000 will die of their disease. ¹⁷ BRAF mutations are estimated to occur in approximately 8-12% of patients with mCRC and represent a poor prognosis for these patients.^3-11 The V600E mutation is the most common BRAF mutation and the risk of mortality in CRC patients with the BRAFV600E mutation is more than two times higher than for those with wild-type BRAF.^17-19

About BRAFTOVI^® (encorafenib)

BRAFTOVI (encorafenib) is an oral small-molecule BRAF kinase inhibitor that targets a key enzyme 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 and others.

About BEACON CRC

BEACON CRC is a randomised, open-label, global Phase 3 trial evaluating the efficacy and safety of BRAFTOVI® (encorafenib) +/- MEKTOVI® (binimetinib) in combination with cetuximab in patients with BRAFV600E-mutant mCRC whose disease has progressed after one or two prior regimens. BEACON CRC is a Phase 3 trial designed to test a BRAF combination targeted therapy in BRAFV600E-mutant mCRC. A total of 665 patients were randomised 1:1:1 to one of the following treatment arms:

1. BRAFTOVI 300 mg orally once daily in combination with cetuximab (BRAFTOVI/cetuximab arm)
2. BRAFTOVI 300 mg orally once daily in combination with cetuximab and binimetinib
3. Irinotecan with cetuximab or FOLFIRI with cetuximab (control arm)

The study was amended to include an interim analysis of endpoints, including ORR. The primary OS endpoint is a comparison of BRAFTOVI + binimetinib in combination with cetuximab with the control arm. Key secondary endpoints assess the efficacy (OS) of BRAFTOVI in combination with cetuximab and BRAFTOVI + binimetinib in combination with cetuximab, in comparison with the control arm respectively. Other secondary endpoints include progression-free survival, duration of response, safety and tolerability.

The trial was conducted at over 200 investigational sites in North America, South America, Europe and the Asia Pacific region. The BEACON CRC trial was conducted with support from Ono Pharmaceutical Co. Ltd., Pierre Fabre Laboratories, Pfizer and Merck KGaA, Darmstadt, Germany (support is for sites outside of North America).

About Pierre Fabre Laboratories

Pierre Fabre Laboratories is a French medical and beauty care company with four decades of experience in innovation, development, manufacturing, and commercialisation in oncology. The company dedicated about 80% of its R&D spendings to oncology in 2022 and has recently declared targeted therapies as its main R&D priority. Its current commercial portfolio in oncology covers colorectal, breast and lung cancers, melanoma, haematology, and pre-cancerous skin conditions like actinic keratosis.

In 2022, Pierre Fabre Laboratories posted 2.7 billion euros in revenues, 69% of which came from international sales in 120 countries. Established in the South-West of France since its creation in 1962, the Group manufactures over 90% of its products in France and employs some 9,600 people worldwide. The company is 86%-owned by the Pierre Fabre Foundation, a government-recognized public-interest foundation, and secondarily by its own employees through an international employee stock ownership plan. Pierre Fabre Laboratories' sustainability policy has been assessed by the independent AFNOR Certification body at the "Exemplary" level of its CSR label (ISO 26 000 standard for sustainable development).

Further information about Pierre Fabre Laboratories can be found at www.pierre-fabre.com, @PierreFabre.