$ARRY, Array BioPharma Reports Financial Result
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Posted On: 05/10/2017 8:24:07 AM
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$ARRY,
Array BioPharma Reports Financial Results For The Third Quarter Of Fiscal 2017
[PR Newswire]
PR NewswireMay 10, 2017
BOULDER, Colo., May 10, 2017 /PRNewswire/ --
COLUMBUS / BRAF-mutant melanoma Part 2 demonstrates positive results and New Drug Application (NDA) filing on track for June or July 2017
New Binimetinib / KEYTRUDA® collaboration initiated with Merck
BEACON CRC Phase 3 enrollment underway based on an attractive safety profile and with early encouraging activity from safety lead-in
Cash, Cash Equivalents and Marketable Securities as of March 31, 2017 were $207 million
Array BioPharma. (PRNewsFoto/Array BioPharma Inc.) (PRNewsFoto/)
Array BioPharma. (PRNewsFoto/Array BioPharma Inc.) (PRNewsFoto/)
Array BioPharma Inc. (ARRY), a biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule cancer therapies, today reported results for its third quarter of fiscal 2017 and provided an update on the progress of its key clinical development programs.
COLUMBUS PHASE 3 TRIAL: Positive Part 2 Results Announced
On May 9, 2017, Array announced top-line results from Part 2 of the Phase 3 COLUMBUS study evaluating binimetinib, a MEK inhibitor, and encorafenib, a BRAF inhibitor, in patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The primary analysis of Part 2 compared progression free survival (PFS) in patients treated with binimetinib 45mg twice daily plus encorafenib 300mg daily (COMBO300) to patients treated with encorafenib 300mg daily as a single agent. The median PFS (mPFS) for patients treated with COMBO300 was 12.9 months compared to 9.2 months for patients treated with single agent encorafenib, with a HR of 0.77 [95% CI 0.61-0.97, p=0.029]. COMBO300 was generally well-tolerated and reported dose intensity and adverse events were consistent with binimetinib (45mg twice daily) plus encorafenib 450mg daily (COMBO450) results from Part 1 of the COLUMBUS trial. Part 2 of COLUMBUS was designed specifically to assess the contribution of binimetinib to the combination of binimetinib and encorafenib by reducing the dose of encorafenib to 300mg in the combination arm to allow for a comparison of equal doses across arms. Further results from Part 2 will be presented at a medical meeting during the second half of 2017.
"The robust PFS benefit and tolerability observed with binimetinib plus encorafenib in COLUMBUS suggest the combination represents a potential important addition to the MEK/BRAF treatment landscape for patients with BRAF-mutant melanoma," said Ron Squarer, Chief Executive Officer, Array BioPharma.
Based on the strength of data from Part 1 and Part 2, Array is on track to file an NDA for COLUMBUS in June or July 2017. The primary endpoint for the COLUMBUS trial is a PFS comparison of COMBO450 versus vemurafenib in Part 1. Array's European partner, Pierre Fabre, remains on track to file the Marketing Authorization Application during the summer.
Melanoma is the fifth most common cancer among men and the sixth most common cancer among women in the United States, with more than 87,000 new cases and over 9,700 deaths from the disease expected in 2017. Novel therapies that target the RAS-RAF-MEK-ERK pathway have a strong scientific rationale for activity in this disease, as up to 50 percent of patients with metastatic melanoma have activating BRAF mutations, the most common gene mutation in this patient population. Currently marketed MEK/BRAF combination agents have a run rate approaching $1 billion in annual worldwide sales.
MERCK COLLABORATION: Binimetinib and KEYTRUDA combination trial announced in MSS colorectal cancer patients
Array entered into a clinical trial collaboration agreement with Merck to investigate the safety and efficacy of binimetinib with Merck's anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in metastatic colorectal cancer patients with microsatellite stable tumors (MSS CRC). The companies entered into this collaboration based on the growing body of preclinical and clinical evidence that the immune activity of an anti-PD-1 therapy, such as KEYTRUDA, can be enhanced when combined with a MEK inhibitor, such as binimetinib.
Array BioPharma Reports Financial Results For The Third Quarter Of Fiscal 2017
[PR Newswire]
PR NewswireMay 10, 2017
BOULDER, Colo., May 10, 2017 /PRNewswire/ --
COLUMBUS / BRAF-mutant melanoma Part 2 demonstrates positive results and New Drug Application (NDA) filing on track for June or July 2017
New Binimetinib / KEYTRUDA® collaboration initiated with Merck
BEACON CRC Phase 3 enrollment underway based on an attractive safety profile and with early encouraging activity from safety lead-in
Cash, Cash Equivalents and Marketable Securities as of March 31, 2017 were $207 million
Array BioPharma. (PRNewsFoto/Array BioPharma Inc.) (PRNewsFoto/)
Array BioPharma. (PRNewsFoto/Array BioPharma Inc.) (PRNewsFoto/)
Array BioPharma Inc. (ARRY), a biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule cancer therapies, today reported results for its third quarter of fiscal 2017 and provided an update on the progress of its key clinical development programs.
COLUMBUS PHASE 3 TRIAL: Positive Part 2 Results Announced
On May 9, 2017, Array announced top-line results from Part 2 of the Phase 3 COLUMBUS study evaluating binimetinib, a MEK inhibitor, and encorafenib, a BRAF inhibitor, in patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The primary analysis of Part 2 compared progression free survival (PFS) in patients treated with binimetinib 45mg twice daily plus encorafenib 300mg daily (COMBO300) to patients treated with encorafenib 300mg daily as a single agent. The median PFS (mPFS) for patients treated with COMBO300 was 12.9 months compared to 9.2 months for patients treated with single agent encorafenib, with a HR of 0.77 [95% CI 0.61-0.97, p=0.029]. COMBO300 was generally well-tolerated and reported dose intensity and adverse events were consistent with binimetinib (45mg twice daily) plus encorafenib 450mg daily (COMBO450) results from Part 1 of the COLUMBUS trial. Part 2 of COLUMBUS was designed specifically to assess the contribution of binimetinib to the combination of binimetinib and encorafenib by reducing the dose of encorafenib to 300mg in the combination arm to allow for a comparison of equal doses across arms. Further results from Part 2 will be presented at a medical meeting during the second half of 2017.
"The robust PFS benefit and tolerability observed with binimetinib plus encorafenib in COLUMBUS suggest the combination represents a potential important addition to the MEK/BRAF treatment landscape for patients with BRAF-mutant melanoma," said Ron Squarer, Chief Executive Officer, Array BioPharma.
Based on the strength of data from Part 1 and Part 2, Array is on track to file an NDA for COLUMBUS in June or July 2017. The primary endpoint for the COLUMBUS trial is a PFS comparison of COMBO450 versus vemurafenib in Part 1. Array's European partner, Pierre Fabre, remains on track to file the Marketing Authorization Application during the summer.
Melanoma is the fifth most common cancer among men and the sixth most common cancer among women in the United States, with more than 87,000 new cases and over 9,700 deaths from the disease expected in 2017. Novel therapies that target the RAS-RAF-MEK-ERK pathway have a strong scientific rationale for activity in this disease, as up to 50 percent of patients with metastatic melanoma have activating BRAF mutations, the most common gene mutation in this patient population. Currently marketed MEK/BRAF combination agents have a run rate approaching $1 billion in annual worldwide sales.
MERCK COLLABORATION: Binimetinib and KEYTRUDA combination trial announced in MSS colorectal cancer patients
Array entered into a clinical trial collaboration agreement with Merck to investigate the safety and efficacy of binimetinib with Merck's anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in metastatic colorectal cancer patients with microsatellite stable tumors (MSS CRC). The companies entered into this collaboration based on the growing body of preclinical and clinical evidence that the immune activity of an anti-PD-1 therapy, such as KEYTRUDA, can be enhanced when combined with a MEK inhibitor, such as binimetinib.
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I'm in it to win it!
NASDAQ DIP and RIP
Here is the best word that describes what i do here.
Intuitive;
means having the ability to understand or know something without any direct evidence or reasoning process.
I was born with it, I'm truly blessed!
Alway's searching for winners'
NASDAQ DIP and RIP
Here is the best word that describes what i do here.
Intuitive;
means having the ability to understand or know something without any direct evidence or reasoning process.
I was born with it, I'm truly blessed!
Alway's searching for winners'