Business Wire

Pierre Fabre Receives European Approval for BRAFTOVI ® (encorafenib) in Combination With Cetuximab for the Treatment of Adult Patients With BRAF V600E -Mutant Metastatic Colorectal Cancer

Share

Intended for international media only/not intended for UK- and US-based media

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200603005490/en/

Pierre Fabre today announced that the European Commission (EC) has approved BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as Erbitux®) for the treatment of adult patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC) who have received prior systemic therapy.1 This approval is based on data from the Phase 3 BEACON CRC trial.1,2 The EC decision is applicable to all 27 EU member states plus Iceland, Liechtenstein, Norway and the United Kingdom.3

“This approval is truly great news and much needed for patients with BRAFV600E-mutant mCRC and for physicians treating this devastating cancer, as until now, there has been no EC-approved therapies specifically indicated for this high-medical-need population,” said Josep Tabernero, MD, PhD, BEACON CRC trial lead investigator and director of the Vall d’Hebron Institute of Oncology in Barcelona, Spain. “The new encorafenib and cetuximab combination regimen will now change the way we treat these patients, with the possibility of delaying disease progression and prolonging their lives.”

The EC decision, which follows the positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on 30 April 2020, is based on available results from the pivotal Phase 3 BEACON CRC trial,2 the first and only randomised Phase 3 trial designed to test a BRAF combination targeted therapy in BRAFV600E-mutant mCRC. The data showed that BRAFTOVI in combination with cetuximab significantly improved overall survival (OS) in patients with BRAFV600E-mutant mCRC (median 9.3 months vs 5.9 months; hazard ratio: 0.61; 95% confidence interval: 0.48–0.77; p<0.0001) and reduced the risk of death by 40%, compared with the cetuximab plus irinotecan-containing regimen (control) arm. Furthermore, the data also reported an improved objective response rate (ORR; 20% vs 2%; p<0.0001; per assessment by blinded independent central review [BICR]), compared with the control arm. BRAFTOVI plus cetuximab demonstrated a well-tolerated safety profile with no unexpected toxicities in the trial. The most common adverse drug reactions (>25%), observed in the BEACON CRC trial, were fatigue, nausea, diarrhoea, dermatitis acneiform, abdominal pain, arthralgia/musculoskeletal pain, decreased appetite, rash and vomiting.1

"We are extremely pleased that patients will now have access, for the very first time, to a targeted therapy specifically for BRAFV600E-mutant mCRC,” said Jean-Luc Lowinski, CEO of Pierre Fabre Medical Care Business Unit. “Today’s approval is a testament to our long-term commitment to advancing care for patients living with difficult-to-treat cancers and to delivering precision medicine. We will now work tirelessly to bring this new treatment option to patients in Europe, as quickly as possible.”

BRAF mutations are estimated to occur in approximately 8–12% of patients with mCRC, and V600E is the most common mutation.4–12 Patients with mCRC who have BRAFV600E-mutant tumours generally have a poor prognosis representing a high unmet medical need.13 Currently, there are no other approved targeted treatments in Europe specifically indicated for this patient population.14,15

Important safety information and recommendations for the use of BRAFTOVI in combination with cetuximab will be detailed in the Summary of Product Characteristics (SmPC), published in the European public assessment report (EPAR) and available in all official EU languages. The full SmPC will be found at: http://www.ema.europa.eu

On 8 April 2020, Pierre Fabre’s partner Pfizer, which has exclusive rights to BRAFTOVI in the USA and Canada, announced that BRAFTOVI, in combination with cetuximab, was approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with mCRC with a BRAFV600E mutation, as detected by an FDA-approved test, after prior therapy.16 Additional submissions of the BEACON data to health authorities around the world are planned.

About Colorectal Cancer
Worldwide, colorectal cancer (CRC) 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 CRC.17 Every year more than 450,000 people in Europe are diagnosed with CRC and approximately 230,000 will die of their disease.18BRAF mutations are estimated to occur in approximately 8–12% of patients with mCRC and represent a poor prognosis for these patients.4–12 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.18–20

About BEACON CRC
BEACON CRC is a randomised, open-label, global Phase 3 trial evaluating the efficacy and safety of BRAFTOVI (encorafenib) ± binimetinib in combination with cetuximab in patients with BRAFV600E-mutant mCRC whose disease has progressed after one or two prior regimens. BEACON CRC is the first and only 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:

  • BRAFTOVI 300 mg orally once daily in combination with cetuximab (BRAFTOVI/cetuximab arm)
  • BRAFTOVI 300 mg orally once daily in combination with cetuximab and binimetinib
  • 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. Secondary endpoints address the efficacy (OS) of BRAFTOVI in combination with cetuximab, compared with the control arm and compared with BRAFTOVI+binimetinib in combination with cetuximab. 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, Pfizer and Merck KGaA, Darmstadt, Germany (support is for sites outside of North America).

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.

On 20 September 2018, the EC granted marketing authorisations for BRAFTOVI and MEKTOVI to be used in combination for the treatment of adult patients with unresectable or metastatic melanoma with a BRAFV600 mutation.1,21 The EC decision is applicable to all 27 EU member states as well as Iceland, Liechtenstein, Norway and the United Kingdom. BRAFTOVI and MEKTOVI have also received regulatory approvals in the USA, Australia, Japan, Argentina and Switzerland. On 27 June 2018, the combination of BRAFTOVI and MEKTOVI was approved by the FDA for the treatment of unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, as detected by an FDA-approved test.22,23 BRAFTOVI and MEKTOVI are not indicated for treatment of patients with wild-type BRAF melanoma.

On 8 April 2020, the US FDA granted the approval for BRAFTOVI, in combination with cetuximab, for the treatment of adult patients with mCRC with a BRAFV600E mutation, as detected by an FDA-approved test, after prior therapy. BRAFTOVI is not indicated for treatment of patients with wild-type BRAF CRC.16

Pfizer has exclusive rights to BRAFTOVI in the USA and Canada. Pfizer has granted Ono Pharmaceutical Co. Ltd. exclusive rights to commercialise BRAFTOVI in Japan and South Korea; Medison exclusive rights to commercialise BRAFTOVI in Israel; and Pierre Fabre exclusive rights to commercialise BRAFTOVI in all other countries in Africa, Asia (excluding Japan and South Korea), Europe, and Latin America.

About Pierre Fabre
Pierre Fabre is the second largest dermo-cosmetics laboratory in the world, the second largest private French pharmaceutical group, and the market leader in France for products sold over the counter in pharmacies. Its portfolio includes several global brands and franchises, including Eau Thermale Avène, Klorane, Ducray, René Furterer, A-Derma, Galénic, Elancyl, Naturactive, Pierre Fabre Health Care, Pierre Fabre Oral Care, Pierre Fabre Dermatologie and Pierre Fabre Oncologie.

In 2019, Pierre Fabre generated 2.4 billion euros in revenues, of which two-thirds originated from its international business.

Pierre Fabre, which has always been headquartered in the South-West of France, employs approximately 10,500 people worldwide, owns subsidiaries and offices in 45 countries and enjoys distribution agreements in over 130 countries.

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

In 2019, Ecocert Environment assessed the Group’s corporate social and environmental responsibility approach according to the ISO 26000 standard on sustainable development and awarded it the ECOCERT 26000 “Excellence” level.

www.pierre-fabre.com
@PierreFabre

References
[1] European Medicines Agency. BRAFTOVI® (encorafenib) Summary of Product Characteristics. Available at: http://www.ema.europa.eu. Publication pending (June 2020).
[2] Kopetz S, et al. Encorafenib, binimetinib, and cetuximab in BRAF V600E–mutated colorectal cancer. N Engl J Med. 2019;381:1632–43.
[3] European Medicines Agency. Brexit: the United Kingdom’s Withdrawal from the European Union. Available at: https://www.ema.europa.eu/en/about-us/brexit-united-kingdoms-withdrawal-european-union#transition-period-section. Accessed May 2020.
[4] Maughan TS, et al. Lancet. 2011;377:2103–14.
[5] Souglakos J, et al. Br J Cancer. 2009;101:465–72.
[6] Richman SD, et al. J Clin Oncol. 2009;27:5931–7.
[7] Tran B, et al. Cancer. 2011;117:4623–32.
[8] Yokota T, et al. Br J Cancer. 2011;104:856–62.
[9] Tie J, et al. Int J Cancer. 2011;128:2075–84.
[10] Loupakis F, et al. Br J Cancer. 2009;101:715–21.
[11] Tviet KM, et al. J Clin Oncol. 2012;30:1755–62.
[12] Vecchione L, et al. Cell. 2016;165:317–30.
[13] Taieb J, et al. J Natl Cancer Inst. 2017;109:djw272.
[14] Ducreux M, et al. Ther Adv Med Oncol. 2019;11:1758835919856494.
[15] Prahallad A, et al. Nature. 2012;483:100–3.
[16] Pfizer. U.S. FDA Approves Braftovi® (encorafenib) in Combination with Cetuximab for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer (CRC) After Prior Therapy. Available at: https://investors.pfizer.com/investor-news/press-release-details/2020/US-FDA-Approves-BRAFTOVI-Encorafenib-in-Combination-with-Cetuximab-for-the-Treatment-of-BRAFV600E-Mutant-Metastatic-Colorectal-Cancer-CRC-After-Prior-Therapy/default.aspx. Accessed May 2020.
[17] The Global Cancer Observatory, 2018. International Agency for Research on Cancer, World Health Organization. Available at: https://gco.iarc.fr/today/online-analysis-multi-bars. Accessed May 2020.
[18] EuropaColon. Colorectal Cancer in Europe: A Framework for Improving Outcomes for Patients. Available at: https://webgate.ec.europa.eu/chafea_pdb/assets/files/pdb/20124301/20124301_d04-00_en_ps_ecwhitepaper.pdf. Accessed May 2020.
[19] Sclafani F, et al. Crit Rev Oncol Hematol. 2013;87:55–68.
[20] Safaee Ardekani G, et al. PLoS One. 2012;7:e47054.
[21] European Medicines Agency. MEKTOVI® (binimetinib) Summary of Product Characteristics. Available at: https://www.ema.europa.eu/documents/product-information/mektovi-epar-product-information_en.pdf. Accessed May 2020.
[22] Array BioPharma. BRAFTOVI® (encorafenib) US Prescribing Information 2018. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210496lbl.pdf. Accessed May 2020.
[23] Array BioPharma. MEKTOVI® (binimetinib) US Prescribing Information 2019. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210498s001lbl.pdf. Accessed May 2020.

Contact information

Pierre Fabre
Valérie Roucoules
(33) 1 49 10 83 84
valerie.roucoules@pierre-fabre.com

About Business Wire

Business Wire
Business Wire



Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Spirit of Wipro Run Brings Together Thousands of Participants Globally27.9.2020 08:52:00 CESTPress release

Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting and business process services company, today organized the 15th edition of the ‘Spirit of Wipro’ (SOW) Run globally with thousands of participants across 35 countries, running separately, yet together in spirit, at a time of their choosing. The theme for this year’s Run was “United. Unstoppable”, which celebrated camaraderie, resilience and a shared sense of community among several thousands of Wipro employees, their friends and families, alumni, customers, partners and suppliers. The SOW Run is an annual, global tradition at Wipro and has been held every year since its inception. This year too, the Run was organized on schedule despite the pandemic induced constraints. The runners strictly adhered to the local COVID-19 guidelines and safety protocols in various countries while participating in the event. Commenting on the Run, Thierry Delaporte, Chief Executive Officer and Managing

BCG Collaborates with Tencent Marketing Insight to Release 2020 BCG x Tencent Digital Luxury Report25.9.2020 12:21:00 CESTPress release

Since early 2020 when the COVID-19 pandemic broke out worldwide, the luxury market has been hit hard and is expected to decline 25% to 45% compared to the previous year. The Chinese luxury market, however, which has benefitted from successful domestic control of the pandemic and has taken the lead in recovery against a depressed global market environment, is forecast to grow from 20% to 30% in the whole year of 2020. Thanks to its stunning market performance, China has become the main battleground of each major luxury brand. In was in this environment that Boston Consulting Group (BCG) joined hands with Tencent Marketing Insight (TMI) to release the 2020 BCG x Tencent Digital Luxury Report, drawing on deep insights into post COVID-19 trends in the luxury market and consumers based on BCG and TMI’s quantitative consumer research and industry experience, as well as TMI’s marketing and big data capabilities. Crystal Hao, Managing Director & Partner of BCG said, “The luxury market in China

U.S. MRTP Authorization Pathway Explored in PMI’s Latest Scientific Update25.9.2020 12:15:00 CESTPress release

Philip Morris International (PMI) (NYSE: PM) has released the 11th edition of its Scientific Update, a regularly issued publication on its research efforts to develop and scientifically assess a range of smoke-free alternatives to cigarettes. The latest edition features an overview of the historic decision made by the U.S. Food and Drug Administration (FDA) to authorize the marketing of the IQOS Tobacco Heating System with reduced exposure information. The Scientific Update explains the various MRTP decisions under U.S. law; the steps, processes, and timeline PMI undertook; and the ongoing post-market surveillance and studies that will monitor the impact of the orders on consumer perceptions, behavior, and health. “The FDA undertook a scientific and regulatory evaluation of IQOS and determined that it is ‘appropriate for the promotion of public health’” said Dr. Gizelle Baker, director of Global Scientific Engagement at PMI. “In this edition of our Scientific Update, we describe how th

Palladio Completes $20 Million Series B Financing25.9.2020 12:09:00 CESTPress release

Palladio Biosciences, Inc. (Palladio), a privately-held, clinical stage biopharmaceutical company developing medicines for orphan diseases of the kidney, announced today the completion of a $20 million Series B investment. The financing was led by new investor, Samsara BioCapital, with participation from new investor, the Roche Venture Fund and existing investors, Medicxi and Osage University Partners. Proceeds from the financing will fund Palladio’s Phase 3 ALERT Study and advance operations. Srinivas Akkaraju M.D, Ph.D, Managing General Partner of Samsara BioCapital, stated, "We are very excited about our investment in Palladio to support the development of lixivaptan, a drug that has the potential to deliver a meaningful therapeutic advancement in the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). The ALERT Study is an important step in assessing the safety differential of lixivaptan.” “We are very pleased that Samsara and the Roche Venture Fund recognize the opp

Ant Group Launches “Trusple,” an AntChain-Powered Global Trade and Financial Services Platform for SMEs and Financial Institutions25.9.2020 09:54:00 CESTPress release

Ant Group, a leading provider in the development of open platforms for technology-driven inclusive financial services, and the parent company of China’s largest digital payment platform Alipay, today unveiled Trusple, an international trade and financial service platform powered by AntChain, the company’s blockchain-based technology solutions. Trusple aims to make it easier and less costly for all participants – especially Small-to-Medium Enterprises (SMEs) – to sell their products and services to customers around the world. It also reduces costs for financial institutions so they can better serve SMEs in need. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200925005110/en/ (Photo: Business Wire) Based on the concept of “Trust Made Simple,” Trusple works by generating a smart contract once a buyer and a seller upload a trading order on the platform. As the order is executed, the smart contract is automatically updated with k

Ipsen Appoints Philippe Lopes-Fernandes as Executive Vice President, Chief Business Officer25.9.2020 07:00:00 CESTPress release

Regulatory News: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200924005822/en/ Philippe Lopes-Fernandes, Executive Vice President, Chief Business Officer, Ipsen (Photo: Business Wire) Ipsen (Euronext: IPN; ADR: IPSEY) today announced the appointment of Philippe Lopes-Fernandes as Executive Vice President, Chief Business Officer, effective 1 October 2020. Based in Cambridge, Massachusetts, USA, he will be responsible for business development and alliance management, reporting directly to David Loew, CEO, Ipsen. Philippe will serve on the Executive Leadership Team. “As Chief Business Officer, Philippe will play a crucial role in our external innovation strategy. The ELT and I are delighted to welcome Philippe to Ipsen and look forward to working closely with him. His extensive and impressive track record in international business development, his outstanding reputation and his ability to work closely with the scientific comm

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom