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Array BioPharma Reports Financial Results For The Second Quarter Of Fiscal 2013
Date:2/4/2013

noma.  This study was recently posted on ClinicalTrials.gov and has a scheduled start date of April 2013.  Please click here to view. Novartis has also recently accelerated its goal of regulatory submissions for MEK162 to 2015.  In addition, Novartis announced plans to pursue additional clinical development in combination with a Raf inhibitor in BRAF mutant melanoma.

Selumetinib – AstraZeneca may initiate Phase 3 trial in 2013AstraZeneca recently announced with their quarterly financial results that they expect to initiate a Phase 3 selumetinib trial in 2013 in patients with NSCLC.  Selumetinib is advancing in 65 trials, 39 of which are in Phase 2.  AstraZeneca initiated a 225-patient Phase 2 randomized trial with selumetinib in combination with docetaxel in 2nd line unselected NSCLC.  The trial will evaluate two different doses of docetaxel with selumetinib versus docetaxel alone.  We believe this will help optimize the product's profile, validate biomarker diagnostics and generate preliminary efficacy in selective subsets of NSCLC patients. Additionally, AstraZeneca will specifically assess efficacy within KRAS subgroups in terms of progression free survival, overall survival, overall response rate and change in tumor size at week 6.

In addition to NSCLC, positive results were presented last year with selumetinib in thyroid and ovarian cancers.  In a Phase 2 trial in recurrent low-grade serous ovarian or peritoneal cancer, patients taking selumetinib showed a disease control rate of 81%, defined as either complete or partial response or progression-free survival or progression-free survival of greater than 6 months.  Eight patients had complete (1) or partial (7) responses.  The median survival rate without cancer progression was 11 months.  And in patients with thyroid cancer, selemetinib showed a 71%
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