Business Wire

Pierre Fabre and its partner Pfizer present interim analysis results from Phase 3 BEACON CRC trial of encorafenib, binimetinib and cetuximab for the treatment of BRAFV600E-mutant metastatic colorectal cancer

Share

Pierre Fabre today announced detailed results from the interim analysis of the Phase 3 BEACON CRC trial evaluating the combination of encorafenib, binimetinib, and cetuximab, in patients with advanced BRAFV600E -mutant metastatic colorectal cancer (mCRC), following one or two lines of therapy. The results show statistically significant improvements in overall survival (OS) and objective response rates (ORR) for encorafenib+binimetinib+cetuximab and encorafenib+cetuximab, compared with cetuximab plus irinotecan-containing regimens (Control), and provide analysis of the efficacy and safety of encorafenib+binimetinib+cetuximab compared with encorafenib+cetuximab. These data will be presented today during a late-breaking oral session at the 2019 European Society for Medical Oncology (ESMO) Congress in Barcelona, Spain, and simultaneously published online in The New England Journal of Medicine (NEJM). The use of encorafenib, binimetinib and cetuximab for the treatment of patients with BRAFV600E -mutant mCRC is investigational and not approved by the European Medicines Agency.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190929005042/en/

To view this piece of content from mms.businesswire.com, please give your consent at the top of this page.

(Photo: Business Wire)

As previously announced at ESMO 21st World Congress on Gastrointestinal Cancer (ESMO GI), encorafenib+binimetinib+cetuximab showed a median OS of 9.0 months for patients treated with this combination, compared with 5.4 months for the Control arm (hazard ratio (HR): 0.52; 95% confidence interval (CI): 0.39-0.70; p<0.0001). The encorafenib+binimetinib+cetuximab combination also demonstrated a statistically significantly improved ORR of 26% (95% CI: 18%, 35%) compared with 2% (95% CI: 0%, 7%) for the Control arm (p<0.0001).

“These interim findings from the BEACON trial presented at ESMO and published in NEJM, demonstrate the potential efficacy and tolerability that encorafenib and binimetinib in combination with cetuximab may offer to patients with mCRC with a BRAFV600E mutation,” said Josep Tabernero, MD, PhD, the BEACON CRC trial lead investigator and director of the Vall d’Hebron Institute of Oncology in Barcelona, Spain. “We look forward to reviewing the results in detail, as patients with this mutation currently have a challenging prognosis and limited treatment options.”

The study also showed improvements in secondary efficacy endpoints. As previously announced, the encorafenib+cetuximab combination demonstrated a statistically significant improvement in OS (median 8.4 months vs. 5.4 months; HR: 0.60; 95% CI: 0.45-0.79; p=0.0003), compared with the Control arm. Additional analysis showed depth of responses in favour of encorafenib+binimetinib+cetuximab.

“The interim data from the BEACON CRC trial are encouraging, as they illustrate the impact of encorafenib and binimetinib in combination with cetuximab as potentially the first chemotherapy-free, targeted regimen for patients with BRAFV600E -mutant mCRC,” said Jean-Luc Lowinski, CEO of the Pierre Fabre Pharmaceuticals Division. “BRAF-mutant mCRC is a devastating cancer, reinforcing the need for effective treatments. These data demonstrate our committment to advance care for patients living with challenging cancers.”

Further, the data provides additional details on the primary and secondary endpoints, including observations of response rates by number of lines of prior therapy, as well as a descriptive analysis of OS comparing the encorafenib+binimetinib+cetuximab arm with encorafenib+cetuximab arm.

The BEACON CRC study was not powered to compare the two experimental arms directly and such a comparison is further limited by the interim nature of the analysis. In the data being presented at ESMO, results of the descriptive analysis of survival comparing encorafenib+binimetinib+cetuximab with encorafenib+binimetinib favoured the encorafenib+binimetinib+cetuximab study arm.

As previously reported at ESMO GI, the encorafenib+binimetinib+cetuximab and the encorafenib+cetuximab study arms showed no unexpected toxicities. Grade 3 or higher adverse events (AEs) were seen in 58%, 50% and 61% of patients in the encorafenib+binimetinib+cetuximab, encorafenib+cetuximab and Control arms, respectively. Discontinuation of therapy due to adverse events was seen in 7%, 8% and 11% of patients in the encorafenib+binimetinib+cetuximab, encorafenib+cetuximab and Control arms, respectively. The most common Grade 3 or higher AEs seen in patients treated with encorafenib+binimetinib+cetuximab were diarrhoea (10% vs 2% in the encorafenib+cetuximab arm and 10% in the Control arm), abdominal pain (6% vs 2% in the encorafenib+cetuximab arm and 5% in the Control arm) and nausea (5% vs <1% in the encorafenib+cetuximab arm and 1% in the Control arm).

Details for the late-breaking oral presentation are below:

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

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)

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 approximately 8-15% of patients with mCRC and represent a poor prognosis for these patients.3-12 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.2,13,14

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 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/MEK combination targeted therapy in BRAFV600E -mutant mCRC. Thirty patients were treated in the safety lead-in and received the combination encorafenib+binimetinib+cetuximab (encorafenib 300 mg daily, binimetinib 45 mg twice daily and cetuximab per label). Of the 30 patients, 29 had a BRAFV600 mutation. Microsatellite instability high, resulting from defective DNA mismatch repair, was detected in only one patient. As previously announced, encorafenib+binimetinib+cetuximab showed an acceptable safety profile that supported 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 the encorafenib+binimetinib+cetuximab, encorafenib+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 encorafenib+binimetinib+cetuximab combination with the control arm. Secondary endpoints address efficacy of encorafenib+cetuximab compared with the control arm, and the encorafenib+binimetinib+cetuximab arm compared with the encorafenib+cetuximab arm. Other secondary endpoints include progression-free survival, 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. The combination of encorafenib and binimetinib is currently only approved for use in metastatic melanoma with a BRAFV600 mutation. The use of encorafenib, binimetinib and cetuximab for the treatment of patients with BRAFV600E -mutant mCRC is investigational and not approved by the European Commission

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 BRAFV600 mutation, as detected by a validated test.18,19 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, Pierre Fabre’s partner Array BioPharma, which has exclusive rights for these medicines in the U.S., announced that the combination of encorafenib and binimetinib 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.20,21 Encorafenib is not indicated for treatment of patients with wild-type BRAF melanoma. In Japan, the combination is approved for unresectable melanoma with a BRAF mutation. encorafenib and binimetinib have received regulatory approval in Australia and the Swiss Medicines Agency (Swissmedic) is currently reviewing the Marketing Authorization Applications for BRAFTOVI and MEKTOVI 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 America 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 over 40 countries and enjoys distribution agreements in over 130 countries. In 2018, Pierre Fabre dedicated 187 million euros to R&D efforts, split between oncology, dermatology, consumer healthcare 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] Maughan TS, et al. Lancet. 2011;377:2103–14.
[7] Souglakos J, et al. Br J Cancer. 2009;101:465–72.
[8] Richman SD, et al. J Clin Oncol. 2009;27:5931–7.
[9] Tran B, et al. Cancer. 2011;117:4623–32.
[10] Yokota T, et al. Br J Cancer. 2011;104:856–62.
[11] Tie J, et al. Int J Cancer. 2011;128:2075–84.
[12] Loupakis F, et al. Br J Cancer. 2009;101:715.
[13] Sclafani F, et al. Crit Rev Oncol Hematol. 2013;87(1):55–68.
[14] Safaee Ardekani G, et al. PLoS One. 2012;7(10):e47054.
[15] Loupakis F, et al. Br J Cancer. 2009;101(4):715–21.
[16] De Roock W, et al. Lancet Oncol. 2010;11(8):753–62.
[17] 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.
[18] 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.
[19] 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.
[20] Array BioPharma. BRAFTOVI® (encorafenib) US Prescribing Information 2018. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210496lbl.pdf. Accessed September 2019.
[21] Array BioPharma. MEKTOVI® (binimetinib) US Prescribing Information 2019. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210498s001lbl.pdf. Accessed September 2019.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

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

Global Tourism Surging Ahead of Economic Growth, With Visits to Hit 30 Billion by 20344.7.2025 02:00:00 EEST | Press release

The World Economic Forum has today published a new report forecasting that the travel and tourism industry is projected to serve 30 billion tourist trips by 2034. Travel and Tourism at a Turning Point: Principles for Transformative Growth, produced in collaboration with Kearney and the Ministry of Tourism Saudi Arabia, reveals a projected $16 trillion contribution to global GDP by the same year—representing more than 11% of the total world economy, according to World Travel & Tourism Council estimates. The report also found that the sector is expanding 1.5 times faster than the global economy, generating significant commercial opportunities as long as the mounting challenges of climate change, labour shortages and infrastructure gaps are addressed. Inbound and outbound trips increasing fast Asia is on track to become the world’s fastest-growing tourism economy, with the direct travel and tourism GDP contribution expected to exceed 7% across the region by 2034. Notably, India and China

The 2025-2026 World Branding Awards Animalis Edition Honouring Leading Pet and Animal Brands Globally3.7.2025 22:00:00 EEST | Press release

The 2025-2026 World Branding Awards Animalis Edition marked its fifth instalment, bringing together leading pet and animal brands from all around the world. These brands were celebrated for their outstanding achievements, earning recognition as National, Regional, and Global Winners. The awards ceremony, held at Vienna's prestigious Hofburg Palace, welcomed winners across diverse categories, including pet food, retail, wellness, pet exhibitions, and aquatic products. Mounia Berrada-Gouzi expertly hosted the evening, which culminated in a grand celebration of brand excellence. “The Animalis Edition of the World Branding Awards recognises brands that have achieved the highest distinction—genuine recognition in the hearts and minds of consumers. Tonight, we honour those whose names resonate globally, whose values inspire loyalty, and whose presence defines excellence in the pet and animal industry,” said Richard Rowles, Chairman of the World Branding Forum. Out of over 950 brands nominate

Venture Global Announces 20-Year Sales and Purchase Agreement with PETRONAS3.7.2025 15:59:00 EEST | Press release

Today, Venture Global, Inc. (NYSE: VG) announced the execution of a new 20-year Sales and Purchase Agreement (SPA) with PETRONAS LNG Ltd. (PLL), a subsidiary of the Malaysian state-owned oil and gas company, PETRONAS. Under the terms of the SPA, PETRONAS will purchase 1 million tonnes per annum (MTPA) of liquefied natural gas (LNG) from Venture Global’s third facility, CP2 LNG, for 20 years. This builds upon Venture Global’s existing agreement with PETRONAS for 1 MTPA of LNG supply from Plaquemines LNG. PETRONAS, a world-class partner in the LNG industry, joins other CP2 LNG customers in Europe, Asia and the rest of the world in a strategically important project to global energy supply and security. To date, approximately 10.75 MTPA of the 14.4 MTPA nameplate capacity for CP2 Phase One has been sold. About Venture Global Venture Global is a long-term, low-cost provider of U.S. LNG sourced from resource rich North American natural gas basins. Venture Global’s business includes assets ac

Frost & Sullivan Recognizes Novotech as 2025 Global Biotech CRO Company of the Year3.7.2025 15:05:00 EEST | Press release

In recognition of its innovation, client-focused delivery, and global impact, Novotech has been awarded the 2025 Global Biotechnology Contract Research Organization (CRO) Company of the Year by Frost & Sullivan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250703950144/en/ Novotech Wins Global CRO Award Novotech is a globally recognized full-service clinical CRO and scientific advisory firm, trusted by biotech and small- to mid-sized pharmaceutical companies to advance their drug development programs at every phase. With a global footprint spanning Asia-Pacific, North America, and Europe, Novotech supports over 5,000 clinical trial sites and a distributed team of experts delivering seamless, end-to-end solutions across geographies. “Novotech is redefining biotech-focused clinical research through AI-driven innovation, global expansion, and a client-embedded partnership model. With a clear vision to be the CRO of choice for

Tinnitus Research: Novel Compound AC102 Makes Constant Ear Noise Disappear in Preclinical Model3.7.2025 13:02:00 EEST | Press release

The novel compound AC102 almost completely reversed tinnitus in a preclinical model after a single dose. At the same time, the damaged connections between the auditory nerve and inner ear sensory cells were restored. These findings were recently published in the prestigious International Journal of Molecular Sciences in a joint study conducted by Erlangen University Hospital and Berlin-based drug developer AudioCure. As there is currently no causal treatment for tinnitus, there is a high medical need. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702168211/en/ In 10-20% of tinnitus cases, the noise in the ear is so severe that it significantly impairs the quality of life of those affected. (Source: AI-generated) In the current study, AC102 was administered to the middle ear of one experimental group after acoustic trauma, while a second group received a placebo. Although both groups initially showed signs of tinnitus, th

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye