On August 30, 2017 Array BioPharma Inc. (Nasdaq: ARRY), a biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule cancer therapies, reported that results from the Phase 3 BEACON CRC safety lead-in study in BRAF-mutant colorectal cancer and the Phase 3 COLUMBUS Part 2 study in BRAF-mutant melanoma will be presented at the 2017 European Society for Medical Oncology Congress in Madrid, Spain on September 9 (Press release, Array BioPharma, AUG 30, 2017, View Source [SID1234520334]). In addition, Array will host an investor reception and webcast on September 9.

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BEACON CRC SAFETY LEAD-IN DATA

A presentation of data from the safety lead-in will take place on Saturday, September 9 from 1:15 – 2:15 pm CEST (7:15 – 8:15 am EDT). The presentation will include details on the safety and tolerability profile of the triplet therapy, encorafenib + binimetinib + cetuximab, as well as preliminary measures of efficacy including overall response rate and available durability results.

Abstract #517P: BEACON CRC: Safety Lead-In (SLI) for the Combination of Binimetinib (BINI), Encorafenib (ENCO), and Cetuximab (CTX) in Patients (Pts) with BRAFV600E Metastatic Colorectal Cancer (mCRC)
COLUMBUS PART 2 TRIAL DATA

Data from Part 2 of the Phase 3 study will be featured as an oral presentation on Saturday, September 9 at 2:45 pm Central European Summer Time (CEST) (8:45 am EDT). The presentation will include progression free survival, objective response rate, dose intensity, safety and tolerability.

Abstract #1215O: Results of COLUMBUS Part 2: A Phase 3 Trial of Encorafenib (ENCO) Plus Binimetinib (BINI) Versus ENCO in BRAF-Mutant Melanoma
ARRAY INVESTOR RECEPTION AND WEBCAST: Array will host an investor reception during ESMO (Free ESMO Whitepaper) 2017 where key opinion leaders in the colorectal cancer field, including Dr. Scott Kopetz, M.D. Anderson and Dr. Axel Grothey, Mayo Clinic will give presentations covering the BRAF-mutant colorectal cancer landscape and data from the BEACON CRC safety lead-in. The presentations will be webcast (live and replay), for those who wish to participate remotely.

Date:
Saturday, September 9, 2017
Time:
4:00-6:00 PM CEST (10:00 am – 12-noon EDT)
Location:
Neuvo Boston Hotel, Madrid, Spain
RSVP:
View Source

Listen Only Dials
Toll-Free:
(844) 464-3927
Toll:
(765) 507-2598
Spain, Madrid
914142503
UK, London
08000288438
Pass Code:
72381291
Webcast:
View Source
Additional data from Array BioPharma and partner compounds will also be presented at ESMO (Free ESMO Whitepaper).

All abstracts can be accessed on August 30, 2017 at 6:05 pm EDT through the ESMO (Free ESMO Whitepaper) website, View Source After the presentation and poster are public, they will be available as PDFs on Array’s website at www.arraybiopharma.com.

About Binimetinib and Encorafenib
MEK and BRAF 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, such as melanoma, colorectal and thyroid cancers. Binimetinib is a late-stage small molecule MEK inhibitor and encorafenib is a late-stage small molecule BRAF inhibitor, both of which target key enzymes in this pathway. Binimetinib and encorafenib are being studied in clinical trials in advanced cancer patients, including the Phase 3 BEACON CRC trial with encorafenib in combination with cetuximab with or without binimetinib in patients with BRAF V600E-mutant colorectal cancer. On July 5, 2017, Array announced that it submitted two NDAs to the Food and Drug Administration (FDA) to support use of the combination of binimetinib 45 mg twice daily and encorafenib 450 mg once daily (COMBO450) for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The submissions are supported by data from the pivotal Phase 3 COLUMBUS study. In addition, Array’s European partner, Pierre Fabre, announced on August 28, 2017, that the European Medicines Agency (EMA) has validated the review of the Marketing Authorization Applications (MAAs) for binimetininb and encorafenib.

Binimetinib and encorafenib are investigational medicines and are not currently approved in any country.

Array BioPharma retains exclusive rights to binimetinib and encorafenib in key markets including the U.S., Canada and Israel. Array has granted Ono Pharmaceutical exclusive rights to commercialize both products in Japan and South Korea and Pierre Fabre exclusive rights to commercialize both products in all other countries, including Europe, Asia and Latin America.