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Array BioPharma Reports Financial Results For The First Quarter Of Fiscal 2014 And Announces ARRY-520 Development Strategy
Date:10/31/2013

ative to the previously-evaluated formulation. In addition, the study is evaluating safety and the preliminary efficacy of ARRY-614 based on Hematologic Improvement (increases in red blood cells, neutrophils and/or platelets), the reduction or independence from red blood cell and/or platelet transfusions, the durability of these responses, and OS.  Mature response data from this trial is expected early next year.  With these results, Array plans to discuss development plans with regulatory authorities.An abstract providing updated data on the current ARRY-614 study has been submitted for presentation at the 2013 ASH Annual Meeting.

Partnered Pipeline ProductsMEK162 (co-developing with Novartis) – Phase 3 trial initiated in BRAF-mutant melanoma
Novartis initiated a Phase 3 trial with MEK162 and the Novartis BRAF inhibitor, LGX818, in BRAF-mutant melanoma based on the safety and efficacy data reported in their trial presented at the 2013 American Society for Clinical Oncology (ASCO) Annual Meeting.  The trial, called COLUMBUS, is a 900-patient randomized, open label, multi-center, parallel group, three-arm study comparing the efficacy and safety of LGX818 plus MEK162 and LGX818 monotherapy, as compared to vemurafenib in patients with locally advanced unresectable or metastatic melanoma with BRAF mutation.

There are now three Phase 3 trials enrolling with MEK162 in advanced cancer patients:  NRAS-mutant melanoma, low-grade serous ovarian cancer and BRAF-mutant melanoma.  NRAS-mutant melanoma represents the first indication for MEK162, and the projected regulatory filing from the NRAS-mutant melanoma study is estimated to be in 2015.Selumetinib (partnered with AstraZeneca) – SELECT-1 Phase 3 trial initiated in non-small cell lung cancer (NSCLC)
AstraZeneca initiated a Phase 3 clinical trial of selumetinib as second-line therapy in patients with KRAS-mutant advanced or metastatic NSCLC based on the strength of Phas
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