Array BioPharma Announces Oral Presentation from the Pivotal Phase 3 COLUMBUS trial of the Combination of Encorafenib and Binimetinib in Patients with BRAF-mutant Melanoma at 2018 ASCO Annual Meeting

May 16, 2018 | By forimmediaterelease.net - | Filed in: Press Releases.

Array BioPharma Announces Oral Presentation from the Pivotal Phase 3 COLUMBUS trial of the Combination of Encorafenib and Binimetinib in Patients with BRAF-mutant Melanoma at 2018 ASCO Annual Meeting

The link to the original content can be found at the end of our message below.

In the past Forimmediaterelease circulated releases distributed through the Cision and PR Newswire system on a complimentary basis and as a service to our readers.

PR Newswire now claims copyright on press releases distributed through the Cision and PR Newswire system.

Their pitch: “Share your brand’s story around the world,” but that’s where it ends. When eTN, as a media outlet for travel and tourism news, tried to publish a release distributed to journalists by PR Newswire, they were told the release must be removed immediately. In addition, PR Newswire threatened eTurboNews with their legal counsel claiming copyright of releases from PR Newswire or Cision circulates on behalf of clients.

Here is the letter received by eTurboNews from a PR Newswire/Cision director:

“Subject: removal request

Please immediately remove the following posting from your site: [website name removed]

PR Newswire distributed this release on behalf of our client [client name removed]

[company name removed] is understandably upset that the release is posted on your site, tagged with Travel & Tourism Industry release: at the start of the text.

As you can see below in the release that we distributed that we did not include any coding or tagging on our end to indicate that the release is relevant to the Travel & Tourism industry: [website link removed]

Please completely remove the posting from your site as soon as possible, and confirm when complete.

Additionally, I am unable to find a licensing agreement between PR Newswire and eTN, or any other associated websites. If you do have a licensing agreement in which PR Newswire has licensed your sites to publish our content, please send a copy to me as soon as possible.

If you do not have a licensing agreement, we request that you remove all PR Newswire content from all of your sites. If I should have our Counsel send an official request, please let me know to whom it should be resent.

Many thanks,

[name removed]

Director CISION PR Newswire”

It appears PR Newswire is not only charging a steep amount of money from companies wanting their releases circulated through their system to journalists but also is now trying to license this content as their copyrighted material. eTN receives more than 2,000 story ideas on a daily basis, we don’t rely on PR Newswire for content, and for sure we won’t pay them a licensing fee for a ‘privilege’ to publish such content.

We urge everyone using PR Newswire services to take a look at this article explaining their modus of operation and misleading reports: http://buzz.travel/prn/ .

PR Newswire is now directly competing with publications. This will result in a drastic drop in pick-ups. They are obviously upset with the attention we received for stoties and the visibility we were able to record way ahead of PR Newswire when it comes to our industry segment.

Journalists of any publication should be warned to consider taking content from PR Newswire or Cision.

Therefore, in the future, if you would like us to consider your press releases for publication, you will need to send it to us directly: For more information, visit: www.buzz.travel .

As a courtesy to our readers, you can find the original release content  at:

{{original_post_url}

 

BOULDER, Colo., May 16, 2018 /PRNewswire/ — Array BioPharma Inc. (Nasdaq: ARRY) announced that it will present data from the Phase 3 COLUMBUS trial of encorafenib and binimetinib in advanced BRAF-mutant melanoma in an oral presentation on June 4, 2018, at the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois. 

“Binimetinib and encorafenib is the first targeted therapy to demonstrate over 30 months median overall survival in a Phase 3 trial and we look forward to presenting the results from the COLUMBUS trial at ASCO,” said Ron Squarer, Chief Executive Officer. “With nearly 15 months median progression-free survival and an attractive tolerability profile, these data underscore the potential of this combination to become an important new treatment option for patients with BRAF-mutant advanced, unresectable or metastatic melanoma.”

As previously announced, the most common Grade 3/4 adverse events (AEs) seen in more than 5% of patients were increased gamma-glutamyltransferase (GGT) (9%), increased creatine phosphokinase (7%), and hypertension (6%) in the encorafenib plus binimetinib group. 

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: 

Monday, June 4, 2018

Time: 

9:12 a.m. – 9:24 a.m. Central Time (10:12 a.m. – 10:24 a.m. Eastern Time)

Location: 

Arie Crown Theater

The abstract can be accessed through the ASCO website, http://abstract.asco.org/, beginning May 16, 2018, at 5:00 p.m. Eastern Time. Following the presentation on June 4, the slides will be available as a PDF on Array’s website at www.arraybiopharma.com.

Array will host an encore webcast presentation of the COLUMBUS trial data.

Encore Webcast:

Date: 

Monday, June 4, 2018

Time: 

11:15 a.m. Central Time (12:15 p.m. Eastern Time)

Toll-Free: 

(844) 464-3927

Toll: 

(765) 507-2598

Pass Code: 

9615719

Webcast, including replay and conference call slides: https://edge.media-server.com/m6/p/8juh6tcn

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 BRAFV600 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 the combination of encorafenib 450 mg daily and binimetinib 45 mg twice daily (COMBO450), encorafenib, 300 mg daily (ENCO 300), or vemurafenib, 960 mg 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 an 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 published in The Lancet Oncology May 2018, 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<0.0001)]. 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.

Array BioPharma has exclusive rights to encorafenib and binimetinib in the U.S. and Canada. 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. Encorafenib and binimetinib are investigational medicines and are not currently approved in any country.

About Array BioPharma
Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule drugs to treat patients afflicted with cancer and other conditions. Ten registration studies are currently advancing related to eight Array-owned or partnered drugs: encorafenib (LGX818), binimetinib (MEK162), ARRY-797, selumetinib (partnered with AstraZeneca), danoprevir (partnered with Roche), ipatasertib (partnered with Genentech), larotrectinib (partnered with Loxo Oncology) and tucatinib (partnered with Seattle Genetics). For more information on Array, please go to www.arraybiopharma.com.

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

CONTACTS: 
Investor Relations
Array BioPharma 
Andrea N. Flynn, Ph.D.
Senior Director, Investor Relations & Corporate Communications
(303) 381-6600
ir@arraybiopharma.com

Media
Y&R PR
Erika Hackmann, Media Relations
(917) 538-3375 
erika.hackmann@yr.com 

Cision View original content with multimedia:http://www.prnewswire.com/news-releases/array-biopharma-announces-oral-presentation-from-the-pivotal-phase-3-columbus-trial-of-the-combination-of-encorafenib-and-binimetinib-in-patients-with-braf-mutant-melanoma-at-2018-asco-annual-meeting-300649914.html

SOURCE Array BioPharma Inc.

 

 

 


To post and circulate your own press release on FIR and the eTN Network  please click here 

 


Comments are closed here.