Business Wire

Pierre Fabre to Present New Data from its Oncology Portfolio at the ESMO Annual Congress

Share

Pierre Fabre today announced that new research from its oncology portfolio will be presented at this year’s European Society for Medical Oncology (ESMO; 27 September–1 October, Barcelona, Spain) Annual Congress. Presentations will include study results for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) in BRAFV600E -mutant melanoma, and encorafenib + binimetinib plus Erbitux® (cetuximab) in BRAFV600E -mutant metastatic colorectal cancer (mCRC), which is being developed in collaboration with Pfizer.

“As a company committed to providing innovation through partnerships for patients who are underserved by current treatment options, we are pleased that key results from the Pierre Fabre oncology portfolio have been accepted for presentation at ESMO 2019 congress,” said Jean Luc Lowinski, Chief Executive Officer of the Pierre Fabre Pharmaceuticals Division. “These data follow one year after the first approval for encorafenib and binimetinib in metastatic melanoma, and build on our unique therapeutic approaches that target specific tumour biomarkers with the goal of prolonging the lives of patients.”

At ESMO, BRAFTOVI® + MEKTOVI® feature in two poster presentations that highlight results of the combination therapy in patients with BRAFV600E -mutant melanoma brain metastases, with evidence of intracranial activity from a case series investigation. Expanded results from the Phase 3 BEACON CRC trial of encorafenib + binimetinib + cetuximab for the treatment of BRAFV600E -mutant mCRC will be presented as a late-breaking oral presentation, adding to the growing body of evidence for this investigational therapy, which could potentially be the first chemotherapy-free, targeted regimen for patients.

Presentations

Title:

Encorafenib plus Cetuximab With or Without Binimetinib for BRAFV600E –Mutant Metastatic Colorectal Cancer: Expanded Results from a Randomized, 3-Arm, Phase III Study vs. the Choice of Either Irinotecan or FOLFIRI plus Cetuximab (BEACON CRC)*

Presenter:

Josep Tabernero

Abstract:

LBA32 (Late breaking oral presentation; abstract available on the ESMO website on 30 September)

Session:

Proffered Paper 2 – Gastrointestinal tumours, colorectal

Date/Time:

Monday, 30 September, 08:00–08:45 Central European Summer Time (CEST)

Location:

Barcelona Auditorium (Hall 2)

 

 

Title:

Intracranial Anti-Tumor Activity in Melanoma Brain Metastases with Encorafenib Plus Binimetinib: A Multicenter, Retrospective Analysis

Presenter:

Jose Lutzky

Abstract:

1360P

Session:

Poster Display Session

Date/Time:

Monday, 30 September, 12:00–13:00 CEST

Location:

Poster Area (Hall 4)

 

 

Title:

A Phase 2, Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600 -Mutant Melanoma Brain Metastasis (MBM) (POLARIS)

Presenter:

Michael A. Davies

Abstract:

1379TiP

Session:

Poster Display Session

Date/Time:

Monday, 30 September, 12:00–13:00 CEST

Location:

Poster Area (Hall 4)

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.1 Every year more than 450,000 people in Europe are diagnosed with colorectal cancer and approximately 230,000 will die of their disease.2 BRAF mutations are estimated to occur in up to 12% of patients with mCRC and represent a poor prognosis for these patients.3,4,5 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.6,2,7 Several irinotecan and cetuximab-containing regimens, similar to the BEACON CRC control arm, have established observed historical published benchmarks in patients with BRAFV600E -mutant mCRC, whose disease has progressed after one or two prior lines of therapy. These benchmarks include ORR of 4% to 8%, median PFS of 2 to 3 months and median OS of 4 to 6 months.8,9,10

About BRAF-mutant Metastatic Melanoma
Melanoma develops when unrepaired DNA damage to skin cells triggers mutations that may lead them to multiply and form malignant tumours. Metastatic melanoma is the most serious and life-threatening type of skin cancer and is associated with low survival rates.11,12 There are a variety of gene mutations that can lead to metastatic melanoma. The most common genetic mutation in metastatic melanoma is BRAF. There are more than 100,000 new cases of melanoma diagnosed in Europe each year,13 approximately half of which have BRAF mutations, a key target in the treatment of metastatic melanoma.14,15

About BEACON CRC
BEACON CRC is a randomised, open-label, global trial evaluating the efficacy and safety of encorafenib, binimetinib and cetuximab in patients with BRAF V600E-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/MEK combination targeted therapy in BRAF V600E-mutant mCRC. Thirty patients were treated in the safety lead-in and received the triplet combination (encorafenib 300 mg daily, binimetinib 45 mg twice daily and cetuximab per label). Of the 30 patients, 29 had a BRAF V600 mutation. Microsatellite instability high, resulting from defective DNA mismatch repair, was detected in only one patient. As previously announced, the triplet combination demonstrated good tolerability, supporting initiation of the randomised portion of the trial. The randomised portion of the BEACON CRC trial is designed to assess the efficacy of encorafenib in combination with cetuximab with or without binimetinib compared with cetuximab and irinotecan-based therapy. 665 patients were randomised 1:1:1 to receive triplet combination, doublet combination (encorafenib and cetuximab) or the control arm (irinotecan-based therapy and cetuximab). The study was amended to include an interim analysis of endpoints, including ORR. The primary overall survival endpoint is a comparison of the triplet combination with the control arm. Secondary endpoints address efficacy of the doublet combination compared with the control arm, and the triplet combination compared with the doublet therapy. Other secondary endpoints include PFS, duration of response, safety and tolerability. Health-related quality of life data will also be assessed. The trial is being conducted at over 200 investigational sites in North America, South America, Europe and the Asia-Pacific region. The BEACON CRC trial is being conducted with support from Pierre Fabre, Ono Pharmaceutical Co. Ltd., and Merck KGaA, Darmstadt, Germany (support is for sites outside of North America).

About encorafenib and binimetinib
Encorafenib is an oral small-molecule BRAF kinase inhibitor and binimetinib) is an oral small-molecule MEK inhibitor that target 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 and others.

On 20 September 2018, the EC granted marketing authorisation for the combination of BRAFTOVI® (encorafenib) and MEKTOVI® (binimetinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation, as detected by a validated test.16,17 The EC decision is applicable to all 28 European Union member states plus Iceland, Liechtenstein and Norway. Encorafenib and binimetinib have also received regulatory approval in the United States (U.S.), Australia and Japan. On 27 June 2018, the combination of encorafenib and binimetinib was approved by the FDA for the treatment of unresectable or metastatic melanoma with a BRAF V600E or BRAF V600K mutation, as detected by an FDA-approved test.18,19 Encorafenib is not indicated for treatment of patients with wild-type BRAF melanoma. The Swiss Medicines Agency (Swissmedic) is currently reviewing the Marketing Authorisation Applications for encorafenib and binimetinib submitted by Pierre Fabre.

Pfizer has exclusive rights to BRAFTOVI® and MEKTOVI® in the U.S. and Canada. Pfizer has granted Ono Pharmaceutical Co. Ltd., exclusive rights to commercialize both products in Japan and South Korea, Medison exclusive rights to commercialize both products in Israel and Pierre Fabre exclusive rights to commercialize both products in all other countries, including Europe, Latin American and Asia (excluding Japan and South Korea).

About Pierre Fabre
With a portfolio representing a continuum of activities spanning from prescription drugs and consumer healthcare products to dermo-cosmetics, Pierre Fabre is the 2nd largest dermo-cosmetics laboratory in the world, the 2nd 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 among which 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 2018, Pierre Fabre generated 2.3 billion euros in revenues, of which 64% came from its international business and 61% from its dermo-cosmetics division. Pierre Fabre, which has always been headquartered in the South-West of France, counts about 11,000 employees worldwide, owns subsidiaries and offices in 47 countries and enjoys distribution agreements in over 130 countries. In 2018, Pierre Fabre dedicated 187 million euros to R&D efforts, split between oncology, consumer healthcare, dermatology and dermo-cosmetics.

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] 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 September 2019.
[2] Colorectal Cancer in Europe: A Framework for Improving Outcomes for Patients. EuropaColon. Available at: https://webgate.ec.europa.eu/chafea_pdb/assets/files/pdb/20124301/20124301_d04-00_en_ps_ecwhitepaper.pdf. Accessed September 2019.
[3] Tveit KM, et al. J Clin Oncol. 2012;30(15):1755–62.
[4] Sorbye H, et al. PLoS One. 2015;10(6):e0131046.
[5] Vecchione L, et al. Cell. 2016;165(2):317–30.
[6] Sclafani F, et al. Crit Rev Oncol Hematol. 2013;87(1):55–68.
[7] Safaee Ardekani G, et al. PLoS One. 2012;7(10):e47054.
[8] Loupakis F, et al. Br J Cancer. 2009;101(4):715–21.
[9] De Roock W, et al. Lancet Oncol. 2010;11(8):753–62.
[10] Clinicaltrials.gov. US National Library of Medicine. S1406 phase II study of irinotecan and cetuximab with or without vemurafenib in BRAF mutant metastatic colorectal cancer.
[11] American Cancer Society. Melanoma Skin Cancer. Available at: https://www.cancer.org/cancer/melanoma-skin-cancer.html. Accessed September 2019.
[12] National Cancer Institute. Survival by Stage. Available at: https://seer.cancer.gov/statfacts/html/melan.html. Accessed September 2019.
[13] Melanoma Patient Network Europe. Melanoma – The Facts. Available at: http://www.melanomapatientnetworkeu.org/melanoma.html. Accessed September 2019.
[14] Klein O, et al. Eur J Cancer 2013;49:1073–1079.
[15] American Cancer Society. What Causes Melanoma Skin Cancer? 2016. Available at: https://www.cancer.org/cancer/melanoma-skin-cancer/causes-risks-prevention/what-causes.html. Accessed September 2019.
[16] European Medicines Agency. BRAFTOVI® (encorafenib) Summary of Product Characteristics. Available at: https://www.ema.europa.eu/documents/product-information/braftovi-epar-product-information_en.pdf. Accessed September 2019.
[17] 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 September 2019.
[18] Array BioPharma. BRAFTOVI® (encorafenib) US Prescribing Information 2018. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210496lbl.pdf. Accessed September 2019.
[19] Array BioPharma. MEKTOVI® (binimetinib) US Prescribing Information 2019. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210498s001lbl.pdf. Accessed September 2019.

Contact information

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

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

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

HighRes Biosolutions and Novo Nordisk partner to transform drug discovery in automated Lab of the Future24.1.2020 17:00:00 EETPress release

HighRes Biosolutions and Novo Nordisk A/S today announced that they will collaborate to design a state-of-the-art robotic platform for high-throughput biologics engineering and characterisation. The integration of a multi-system robotics platform with sophisticated software control architecture will enable a digital transformation and accelerated discovery for Novo Nordisk’s peptide and large molecule therapeutics research. “In order to maintain our leadership within biologics engineering we are investing in a fully automated and digital design platform. This investment is linked to our build-up in AI and advanced analytics and demonstrates Novo Nordisk’s commitment as a world leading biologics research company,” said Lars Fogh Iversen, senior vice president, Global Research Technologies, Novo Nordisk. The platform will comprise several highly automated and integrated cells for production, characterisation and functional analysis of thousands of biologic compounds every month. Its scop

Conquest Invests in 5 Greenfield Onshore Wind Parks Totalizing 43MW in the Flanders Region24.1.2020 15:37:00 EETPress release

Conquest, acting through the Conquest Sustainable Infrastructure fund, announced the transaction was closed after an exclusive agreement had been reached with ENGIE Electrabel. Conquest acquires 51% of a portfolio expected to provide 111 GWh per annum of renewable power representing the annual electricity consumption of about 32,000 Belgian homes from early 2021 onwards. The projects benefit from 15 to 20-year green certificates local remuneration schemes, and thus generate yearly secured revenues. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200124005221/en/ Credit: Electrabel While the energy and digital transitions continue to drive the infrastructure sector, Conquest keeps building its diversified sustainable real asset portfolio in Western European markets. The success lies in years of collaboration and long-lasting partnerships with fellow industry experts who can notably facilitate access to new growth opportunities

Fluence Expands EMEA Footprint with Horticulture Partners in Papenburg, Germany24.1.2020 14:00:00 EETPress release

Fluence by OSRAM (Fluence), a leading global provider of energy-efficient LED lighting solutions for commercial cannabis and agriculture production, announced today it is expanding its presence in the Emsland region of Germany through partnerships with growers and other horticulture specialists operating out of Papenburg. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200124005109/en/ Friedrich Schulz’s 5.5 hectare farm—which grows herbs year-round in addition to lettuce, peppers and chives—utilizing VYPR 2p fixtures. (Photo: Business Wire) Given Papenburg’s decades-long history of attracting horticulture experts, Fluence’s innovative lighting solutions for horticulture are a natural fit for the region’s tomato, cucumber, leafy greens and herb growers. Forging connections with Papenburg’s horticultural leaders Elektro Evers, an engineering firm specializing in greenhouse technology, is Fluence’s exclusive systems integrator

HCL Technologies Honors Global Goodwill Champions at the 2020 World Economic Forum in Davos24.1.2020 12:47:00 EETPress release

HCL Technologies (HCL), a leading global technology company, today presented its Wave Maker Awards 2020, commemorating global goodwill champions from around the world. The award ceremony, which was held at the HCL Pavilion in Davos, celebrated organizations and individuals passionately committed to such noble causes as diversity & inclusion, education & community upliftment, environment & sustainability, and technology for change. Special guest at the awards was Australian cricket legend Glenn McGrath, who is also founder of the McGrath Foundation, which provides support for Australian women diagnosed with breast cancer and their families. The award recipients were; Lois Auta, Founder and Executive Director of Cedar Seed Foundation, which supports persons with disabilities to participate in all aspects of life; Chido Govera, Founder and Director of The Future of Hope Foundation (TFoHF), which supports marginal and vulnerable members of society through entrepreneurial and self-developme

Ipsen’s palovarotene clinical program in fibrodysplasia ossificans progressiva reaches prespecified interim analysis futility criteria24.1.2020 09:00:00 EETPress release

Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) today announced the decision to pause dosing patients in the global Phase III (PVO-1A-301) study designed to evaluate the efficacy and safety of palovarotene in patients with fibrodysplasia ossificans progressiva (FOP), as well as the ongoing Phase II (PVO-1A-202/204) extension studies. In both the Phase III and Phase II extension studies, palovarotene is dosed both chronically (daily) and episodically (during flare-ups). The decision to pause dosing patients in the trial is based on results of a futility analysis reviewed by the Independent Data Monitoring Committee (IDMC) as part of the prespecified interim analysis. The results of a futility analysis indicated that the Phase III FOP trial was unlikely to meet its primary efficacy endpoint (annualized change in new HO volume as compared with Natural History Studyi) upon completion. Despite the results of the prespecified interim analysis, signals of encouraging therapeutic activity w

Amazentis Announces the Launch of Timeline™ Cellular Nutrition at the World Economic Forum in Davos23.1.2020 23:56:00 EETPress release

Amazentis announces the debut of Timeline, a next generation nutrition product designed to promote healthy aging, as part of the Swiss Food & Nutrition Valley in the House of Switzerland at the World Economic Forum in Davos, Switzerland. Given the increase in the aging population globally -- according to a 2019 Deutsche Bank study, there are more people on Earth older than sixty five than younger than five for the first time -- it is imperative for consumers to take proactive measures to maintain a high quality of life, for as long as they live. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200123005820/en/ (Photo: Business Wire) Timeline contains the proprietary nutrient Mitopure™, a highly pure form of Urolithin A. After a decade of rigorous research by leading scientists around the world, Mitopure has been shown to help counter age-associated cellular and muscular decline by revitalizing the mitochondria, the powerplants

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