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

rf IDEAS ® Adds HID ® Mobile Access to Its WAVE ID ® Mobile Offering6.7.2020 22:57:00 CESTPress release

rf IDEAS, a leading manufacturer of credential readers for logical access and authentication, continues to advance the future of secure mobile access. Developed in partnership with HID Global, the newest addition to the rf IDEAS WAVE ID Mobile reader line supports the HID Mobile Access credential on Bluetooth® Low Energy enabled mobile devices. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200706005578/en/ WAVE ID® Mobile for HID® Mobile Access (Graphic: Business Wire) The WAVE ID Mobile for HID Mobile Access provides smartphone users with contactless logical access to workstations, networks, applications, secure printers and more via the HID credential. This new reader also provides support for nearly any physical proximity or contactless smart card in use worldwide. The HID Mobile Access credential can be obtained from HID Global through rf IDEAS. It is based on the highly secure SEOS® platform and delivered through an ea

New UC Berkeley Global Program for Freshmen Offers an Online “Study-Abroad” Option6.7.2020 19:40:00 CESTPress release

UC Berkeley Global is proud to announce its Global Program for Freshmen (GPF), launching Fall 2020. This unique “online study-abroad” program is designed for incoming first-year university students seeking a close-knit, collaborative learning community within a digital-learning environment. Students will have access to Berkeley instructors and mentors while working closely with their peers in small cohorts using online tools. GPF offers courses in Letters & Science (L&S) that cover key prerequisites for majors across various disciplines. Elective courses allow students to complete a total of 15 credits per semester, while additional programming will focus on important issues for first-year students, including preparing for college life, selecting a major and career development. Upon completion, students earn credits that they can transfer to their home institution. This makes GPF an ideal opportunity for universities seeking a high-quality online option for their incoming students, or

Research Enhances Understanding of the Nutritional and Economic Differences in Soybean Meal from Different Origins6.7.2020 16:17:00 CESTPress release

A new meta-analytical study reinforces U.S. Soy’s reputation for being a global leader in quality and nutrient-density. The study, entitled, “Chemical composition, protein quality and nutritive value of commercial soybean meals produced from beans from different countries,” demonstrates that not all soybean meals are created equal and that meal from different countries of origin should be treated individually when formulating swine and poultry diets. The data from this study were then processed by the Nutrient Value Calculator (NVC), a software tool constructed by Genesis Feed Technologies, a company built to bring visibility into feed costs. This cost analysis supported the economic benefits of U.S. soybean meal relative to meal from other origins as a key ingredient in poultry rations. Dr. Gonzalo Mateos, Professor of Animal Science at the University of Madrid in Spain and study co-author, first presented findings from the meta-analysis at the U.S. Soybean Export Council’s (USSEC) As

Echosens Announces NICE, UK Health Technology Assessment Organization, Issues MedTech Innovation Briefing on FibroScan Liver Exam in Primary Care6.7.2020 15:00:00 CESTPress release

Echosens, a high-technology company offering the FibroScan family of products, announces today that the National Institute for Health and Care Excellence (NICE), the United Kingdom’s health technology assessment body providing national guidance and advice to improve health and social care, issued a MedTech Innovation Briefing (MIB) dedicated to utilization of FibroScan non-invasive technology in the primary care setting. The NICE experts concurred that this approach could provide a cost-effective way for the National Health System (NHS) to assess liver fibrosis and cirrhosis in primary care--reducing the need for treatment, referrals and biopsies, and improving accuracy and speed. “Using FibroScan as an interventional therapy helps primary care physicians and nurse specialists engage patients by demonstrating the results and outcomes as a value change that patients can visualize on a regular basis and give them confidence that their efforts have an impact,” says Louise Campbell, patien

WEP Clinical Partners With Nabriva Therapeutics for the Named Patient Supply of XENLETA ® (lefamulin)6.7.2020 13:00:00 CESTPress release

WEP Clinical (WEP), a specialist pharmaceutical services company, has signed an exclusive agreement with Nabriva Therapeutics (Nabriva) to supply XENLETA® (lefamulin) on a named patient or expanded access basis. The Named Patient Program (NPP) is designed to ensure that physicians, contingent on meeting the necessary eligibility criteria and receiving approval, can request IV or oral XENLETA on behalf of patients who live in certain countries where it is not yet available. XENLETA was discovered and developed by Nabriva (NASDAQ: NBRV), a commercial-stage biopharmaceutical company focused on commercialization and development of anti-infective agents. It is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms. XENLETA is the first and only oral and IV pleuromutilin empiric antibiotic that acts against the pathogens that commonly cause CABP. Nabriva announced on May 29th

Pudu Robotics Raised over $15M Series B Financing with Meituan as the Exclusive Investor6.7.2020 11:11:00 CESTPress release

On July 1, 2020, Pudu Robotics, an indoor delivery robot provider, officially announced the completion of B round financing of more than $15M with Meituan as the exclusive investor. Zhang Tao, CEO of Pudu Robotics, said the fund would be mainly used to develop products, expand sales, explore new usage scenarios and expand overseas market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200706005180/en/ (Photo: Business Wire) Pudu Robotics is a top-notch intelligent indoor delivery robot provider in China. The company focuses on the R&D, design and production of robots and offers a number of popular delivery robots, including PuduBot (food delivery robot), BellaBot (food delivery robot), HoloBot (building delivery robot), HolaBot (dish-return robot), and GazeBot (multi-scene delivery robot). Its first mass-produced robot PuduBot has been widely used in extensive scenarios, including restaurants, hotels, office buildings, hospi

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