Business Wire

Pierre Fabre and Array BioPharma Announce COLUMBUS Phase 3 Study Overall Survival Results in BRAF-Mutant Melanoma Will Be Presented at 2018 ASCO Annual Meeting

Del

Pierre Fabre with its partner Array BioPharma Inc. will present overall survival (OS) data from its late-stage candidates encorafenib, a BRAF inhibitor, and binimetinib, a MEK inhibitor, at the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO), being held June 1-5, 2018 in Chicago, Illinois.

Survival data from the Phase 3 COLUMBUS trial of encorafenib and binimetinib in BRAF-mutant unresectable advanced melanoma will be highlighted in an oral presentation on June 4, 2018.

“We are delighted by the continued promising results of the encorafenib and binimetinib combination observed in the COLUMBUS trial,” said Frédéric Duchesne, Chief Executive Officer of the Pierre Fabre Pharmaceuticals Division. “As treatment options for patients with -mutant melanoma are limited, there remains a need for new options that can demonstrate efficacy and tolerability. We look forward to sharing additional information about our exciting combination targeted therapy with the medical community at this year’s ASCO.

Oral Presentation:

Title:     Overall Survival in COLUMBUS: A Phase 3 Trial of Encorafenib (ENCO) Plus Binimetinib (BINI) vs Vemurafenib (VEM) or ENCO in BRAF-Mutant Melanoma
 
Presenter: Reinhard Dummer, M.D.
 
Abstract: Abstract #223875/Publication #9504
 
Session: Melanoma/Skin Cancers
 
Date/Time: Monday, June 4, 9:12 a.m. - 9:24 a.m. Central Time (Oral Presentation)
 
Location: Arie Crown Theater

The abstract is available on the ASCO website.

About Melanoma
Metastatic melanoma is the most serious and life-threatening type of skin cancer and is associated with low survival rates. [1, 2] There are about 200,000 new cases of melanoma diagnosed worldwide each year, approximately half of which have BRAF mutations, a key target in the treatment of metastatic melanoma. [1, 3, 4]

About COLUMBUS
The COLUMBUS trial, (NCT01909453), is a two-part, international, randomized, open-label Phase 3 trial evaluating the efficacy and safety of the combination of encorafenib and binimetinib compared to vemurafenib and encorafenib monotherapy in 921 patients with locally advanced, unresectable or metastatic melanoma with BRAF V600 mutation. Prior immunotherapy treatment was allowed. Over 200 sites across North America, Europe, South America, Africa, Asia and Australia participated in the trial. Patients were randomized into two parts:

  • In Part 1, 577 patients were randomized 1:1:1 to receive encorafenib 450 mg daily + binimetinib 45 mg twice daily (COMBO450), encorafenib, 300 mg daily (ENCO 300), or vemurafenib, 960 mg alone twice daily alone. The dose of encorafenib in the combination arm is 50% higher than the single-agent maximum tolerated dose of 300 mg. A higher dose of encorafenib was possible due to improved tolerability when combined with binimetinib. The primary endpoint for the COLUMBUS trial was a median progression-free survival (mPFS) comparison of the COMBO450 arm versus vemurafenib. mPFS is determined based on tumor assessment (RECIST version 1.1 criteria) by a Blinded Independent Central Review (BICR). Secondary endpoints include a comparison of the mPFS of COMBO450 arm to that of ENCO300 and a comparison of overall survival (OS) in patients treated in the COMBO450 arm to that of vemurafenib alone. Results from Part 1 of the COLUMBUS trial previously presented at the 2016 Society for Melanoma Research Annual Congress showed that COMBO450 more than doubled mPFS in patients with advanced BRAF-mutant melanoma, with a mPFS of 14.9 months compared with 7.3 months observed with vemurafenib (HR 0.54 [95% CI 0.41-0.71], p<0.001). In the secondary mPFS comparison of COMBO450 to ENCO300, ENCO300 demonstrated a mPFS of 9.6 months (HR 0.75 [95% CI 0.56-1.00), p=0.051).
  • In Part 2, 344 patients were randomized 3:1 to receive encorafenib 300 mg daily plus binimetinib 45 mg twice daily (COMBO300) or ENCO300. Part 2 was designed to provide additional data to help evaluate the contribution of binimetinib to the combination of encorafenib and binimetinib.

As the secondary endpoint comparison of mPFS between the COMBO450 arm and ENCO300 arm in Part 1 did not achieve statistical significance, the protocol-specified analysis of OS is descriptive.

About Encorafenib and Binimetinib
BRAF and MEK are key protein kinases in the MAPK signaling pathway (RAS-RAF-MEK-ERK). Research has shown this pathway regulates several key cellular activities, including proliferation, differentiation, survival and angiogenesis. Inappropriate activation of proteins in this pathway has been shown to occur in many cancers, including melanoma and colorectal cancer. Encorafenib is a late-stage small molecule BRAF inhibitor and binimetinib is a late-stage small molecule MEK inhibitor, both of which target key enzymes in this pathway. Encorafenib and binimetinib are being studied in clinical trials in advanced cancer patients, including the Phase 3 COLUMBUS trial and the Phase 3 BEACON CRC trial.

Pierre Fabre has exclusive rights to commercialize encorafenib and binimetinib in Europe, Asia, Latin America and Australia. Pierre Fabre’s development partner, Array BioPharma, has exclusive rights in the U.S. and Canada, and has granted Ono Pharmaceutical exclusive rights to commercialize both products in Japan and South Korea. Encorafenib and binimetinib are investigational medicines and are not currently approved in any country.

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 2017, Pierre Fabre generated 2,318 million euros in revenues, of which 62% 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 13,500 employees worldwide, owns subsidiaries and offices in 47 countries and enjoys distribution agreements in over 130 countries. In 2017, Pierre Fabre dedicated ca. 175 million euros to R&D efforts, split between oncology, central nervous system, consumer healthcare, dermatology and dermo-cosmetics.

Pierre Fabre 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.

The independent French certification group AFNOR audited Pierre Fabre for its corporate social responsibility policy at the “exemplary” level, according to the ISO 26000 standard for CSR.

To find out more about Pierre Fabre, please go to www.pierre-fabre.com.

References
[1] Melanoma Skin Cancer. American Cancer Society. Available at: https://www.cancer.org/cancer/melanoma-skin-cancer.html. Accessed May 2018.
[2] A Snapshot of Melanoma. National Cancer Institute. Available at: https://seer.cancer.gov/statfacts/html/melan.html. Accessed May 2018.
[3] Globocan 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012. http://globocan.iarc.fr/Pages/fact_sheets_population.aspx. Accessed May 2018.
[4] Klein O, et al. Eur J Cancer, 2013.

Contact information

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

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

myPOS Presented with Best POS Innovation Award by the Merchant Payment Ecosystem21.2.2019 14:57:00Pressemelding

myPOS, one of the fastest growing European payment providers was handed the Best POS Innovation/POS Software Payment Applications award for 2019 by the Merchant Payment Ecosystem (MPE) at a Gala Dinner ceremony in Berlin last night. Being known for offering instant settlement and no-monthly-fees model to SMEs across Europe, myPOS provides a range of innovative features on its payment devices, some of which include Tipping, Payment Request, Top-up and GiftCards. In addition, myPOS merchants are entitled to a whole range of subscription-free, value-added services such as Virtual MO/TO, PayLinks and PayButtons, Checkout module with the most popular shopping carts and more. myPOS clients are also given the opportunity to manage their funds with a free online account and a unique banking platform. The company got nominated in two categories: Best POS Innovation and Best Acquirer of the year, but ultimately won the Best POS Innovation award. "We accept this award with gratitude and appreciat

New Release Crea Records: "ABBA We Love You Forever"21.2.2019 14:44:00Pressemelding

Not many people on this earth can say that they have never heard of ABBA. In addition to the wonderful voices of Agnetha Fältskog and Anni-Fried Lyngstad, the musicians, Björn Ulvaeus and Benny Andersson have written the most wonderful songs, not only composed with charm and elegance, but also so breathtakingly beautiful and unforgettable that they will always resonate. For the Danish singer, BILLBOARD Hot 100 artist, composer and lyricist, Lecia Jonsson, ABBA has been much more than an inspiration. Lecia shared the same melodic universe as ABBA, making her mark with many records as part of duo LECIA & LUCIENNE. Later, as part of another duo, LABAN, Lecia entered BILLBOARD HOT 100 in the United States, had releases in 48 countries worldwide, and sold more than 1.5 million albums. Lecia’s identity is formed by her pure voice and her great sense for writing unique songs filled with a great melodic substance. If anyone should write a song to honour ABBA’s music, Lecia is definitely the pe

Ultivue Expands Global Presence with Opening of European Subsidiary, Ultivue EMEA Srl21.2.2019 14:30:00Pressemelding

Ultivue, a developer of tissue biomarker identification and quantification assays for pathology and translational research labs, today announced that it has expanded its commercial footprint with a wholly-owned European subsidiary and appointed Luigi Pirovano as General Manager. Mr. Pirovano is an international executive with significant experience managing European Diagnostics and Life Science operations and will be responsible for managing the new subsidiary, Ultivue EMEA Srl, located in Milan, Italy. “The establishment of a European subsidiary provides an excellent structure to support Ultivue’s expanded commercial activities across Europe and engage deeply and efficiently with the biomedical community,” said Philippe Mourere, Ultivue’s Senior Vice President of Commercial Operations. “Ultivue will capitalize on Luigi’s demonstrated success leading both Life Science and Diagnostics activities to continue driving strong execution of its business plan.” Luigi Pirovano has more than 30

Seoul Semiconductor Made Global Distributor Stop Selling Everlight Product in Japan21.2.2019 14:00:00Pressemelding

Seoul Semiconductor Co., Ltd. (KOSDAQ 046890) (“Seoul”), a leading global innovator of LED products and technology, announced that it has concluded a patent infringement lawsuit seeking an injunction on the sales of certain LED product sold by Mouser Electronics (“Mouser”). The accused LED product was manufactured by Everlight Electronics Co., Ltd. (“Everlight”). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190221005040/en/ Seoul Semiconductor's Headquarters in Korea (Photo: Business Wire) In February 2018, Seoul filed a patent infringement lawsuit with the Tokyo District Court, accusing the LED product manufactured by Everlight and sold by Mouser of infringing an LED patent of Seoul’s affiliate. Mouser agreed not to export the accused Everlight LED product in Japan, and Seoul therefore agreed to withdraw the lawsuit. The patented technology involved in this litigation serves to efficiently extract light emitted from the i

NTT DATA Launches Advanced 3D Digital Map Package for 5G Network Planning21.2.2019 14:00:00Pressemelding

NTT DATA (TOKYO:9613), a leading IT services provider, announced today its launch of “AW3D Telecom for 5G,” an advanced 3D digital map package that leverages high-quality satellite imagery for the planning of fifth-generation (5G) wireless networks, effective immediately. AW3D for 5G is expected to be used by telecom carriers, network vendors and IoT companies engaged in businesses involving 5G networks. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190221005320/en/ Images of AW3D Telecom for 5G (Graphic: Business Wire) Commercial 5G services via fixed wireless access networks launched in the USA in 2018 and will begin operating in Japan, South Korea, the UK and Australia in 2019. Accurate 3D models are crucial for designing 5G networks, which use millimeter-spectrum waves that are highly sensitive to interference from natural and manmade objects. Buildings, trees, bridges, flyover roads, etc. need to be expressed precisely

Universal Laser Systems Maximizes Material Compatibility in New ULTRA 9 Platform21.2.2019 13:05:00Pressemelding

With the increasing use of advanced materials in industrial applications from aerospace to medical devices comes a growing need for innovation in material conversion technology. Developments in laser processing aim to overcome the limitations of existing technology and push the boundaries of how materials can be used. To this end, Universal Laser Systems has released a platform with unprecedented material processing capabilities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190221005340/en/ ULTRA 9 laser platform (Photo: Business Wire) The new ULTRA 9 Platform is designed to perform laser cutting, laser ablation, and laser surface modification. When configured with patented MultiWave Hybrid™ technology, it can combine the laser energy of up to three wavelengths – 9.3 µm (CO2), 10.6 µm (CO2), and 1.06 µm (fiber) – by independently controlling each spectral component of the beam. The user is able to select the ideal waveleng