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
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.
|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|
|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.
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]
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.
 Melanoma Skin Cancer. American Cancer Society. Available at: https://www.cancer.org/cancer/melanoma-skin-cancer.html. Accessed May 2018.
 A Snapshot of Melanoma. National Cancer Institute. Available at: https://seer.cancer.gov/statfacts/html/melan.html. Accessed May 2018.
 Globocan 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012. http://globocan.iarc.fr/Pages/fact_sheets_population.aspx. Accessed May 2018.
 Klein O, et al. Eur J Cancer, 2013.
Valérie Roucoules, (33) 1 49 10 83 84
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
IFF-LMR Naturals Leads Industry with 90 Certified Vegan Natural Extracts16.11.2018 00:15 | Tiedote
Regulatory News: IFF-LMR, a subsidiary of International Flavors & Fragrances Inc (NYSE:IFF) (Euronext Paris: IFF) (TASE: IFF) announced their industry-leading position of 90 natural extracts in their portfolio certified vegan by the EVE (Expertise Vegan Europe) VEGAN standards. The certified extracts include Rose EssentialTM, Rose UltimateTM, Blackcurrant Buds Absolute, Ylang Oil Complete, Vetiver Oil Haiti, Patchouli Oil Indonesia, and Geranium Heart Oil, among many others. Bertrand de Preville, General Manager, IFF-LMR said, “Our people are passionate about creating the finest ingredients and together, we are committed to delivering premium, 100% pure and natural extracts. We believe in transparency, environmental management and sustainable development.” Mr. de Preville continued, “This certification of 90 extracts is in line with IFF-LMR’s continuous dedication to our planet, people, plants and animals.” The EVE VEGAN label was selected because it is considered one of the most rigor
Rimini Street Expands Investment and Operations in Asia-Pacific15.11.2018 23:00 | Tiedote
Rimini Street, Inc. (Nasdaq: RMNI), a global provider of enterprise software products and services, and the leading third-party support provider for Oracle and SAP software products, today announced that it has expanded its operations in the Asia-Pacific region with the launch of its new subsidiary, Rimini Street New Zealand Limited, and the opening of its new office in Auckland to address the growing demand for Rimini Street’s premium, ultra-responsive support services in New Zealand. Rimini Street’s expansion was announced at a gala event held at The Northern Club in Auckland, where clients, local IT leaders and the special guest of honor, Ambassador Scott P. Brown, the U.S. Ambassador to New Zealand, were hosted by Rimini Street’s general manager for Asia-Pacific, Andrew Powell, and Rimini Street corporate senior executives. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181115005037/en/ Rimini Street launches subsidiary
Sartorius Stedim Biotech and Lonza Modify Relationship for Supply of Cell Culture Media15.11.2018 21:15 | Tiedote
Sartorius Stedim Biotech (SSB) (Paris:DIM), a leading international supplier of the biopharmaceutical industry, and Lonza announced today that they have modified their current agreement for supply of cell culture media by mutual accord. The agreement, signed in 2012, gave SSB exclusive sales and marketing rights for certain cell culture media and buffers developed and manufactured by Lonza for use in biopharmaceutical manufacturing processes. Lonza retained sales for research-based products, among others. Under agreements signed today, SSB will continue to offer current and future Lonza media and buffers on a non-exclusive basis as part of its extensive portfolio of products for cell-based development and manufacturing. Lonza Pharma & Biotech resumes sales and marketing of all its media products for both manufacturing and research. Customers of both companies will continue to be able to source media products for their specific needs. “We have a long-standing and productive partnership
Intertops Poker Launches its 20 Event Strong SOFT Series for its Recreational Player Base15.11.2018 20:46 | Tiedote
Intertops Poker has launched a new tournament series aimed and created for its recreational and casual player base, with impressive prizes up for grabs. The Intertops Poker SOFT Series is spread across 20 events and offers a combined prize pool of $24,850, including a $4,100 World Series of Poker Caribbean prize package. The series starts on 19th November and will conclude on 25th November. It is available to players from all countries and markets wanting to test their skills and have fun at the tables. There are a wide range of buy-ins to suit all budgets, and the tournament kicks-off with two $500 freerolls before the series gets underway proper on 20th November. Each SOFT Series event winner will receive an Intertops Poker Soft Series Champion hoodie and a seat at the table for the Champions Tournament. The highlight of the series, the Champions Tournament takes place on 25th November at 6:30pm ET and has a guaranteed World Series of Poker Caribbean prize worth $4,100. The World Ser
Telstra: Capital Planning & Delivery Named PMO of the Year15.11.2018 20:21 | Tiedote
Today, Project Management Institute (PMI), the world’s leading association for the project, program and portfolio management profession, announced that Telstra: Capital Planning & Delivery (Melbourne, Australia) has been awarded the 2018 PMO of the Year Award. In 2012, Telstra created the Capital Planning and Delivery (CP&D) function as a dedicated capability within the Finance and Strategy organization. Their purpose was clear – support the annual capital investment allocation, prioritization, and planning processes to better support investment programs and projects. Since that time, it has created a single enterprise wide investment gating model, created a sponsorship engagement model going from 0% of sponsors engaged at the start to 77% today, and enabled a culture of never stopping projects to one that stops non-viable efforts. With many other accomplishments, the core was a cultural transformation. Engagement of sponsors, enabling project management development opportunities and c
Acuris Risk Intelligence and FinScan® Announce Global Strategic Partnership15.11.2018 19:12 | Tiedote
Acuris Risk Intelligence, an independent provider of data intelligence for Anti-Money Laundering (AML), Anti-Corruption and Cyber Security; and FinScan, a global leader in AML compliance solutions, have joined forces to deliver an integrated platform for seamless and efficient watch list screening and customer due diligence. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181115005681/en/ FinScan provides advanced sanctions, Politically Exposed Persons (PEP) and adverse media screening solutions for organisations worldwide. Its intelligent matching technology drastically reduces false positives and the risk of missing true hits. By combining FinScan’s accuracy and scalability with Acuris Risk Intelligence’s specialised knowledge, the partnership enables clients to screen customers and vendors against any high-risk or sanction lists using the deployment method of their choice. Joel Lange, managing director at Acuris Risk Intel
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme