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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

with IMiDs and proteasome inhibitors, the vast majority of patients progress on these therapies leaving an unmet need for novel agents which provide benefit in combination with, and after these therapies have failed.  ARRY-520 has demonstrated activity as a monotherapy in heavily pre-treated patients as well as in combination with both Kyprolis® (carfilzomib) and Velcade® (bortezomib).  Across multiple studies, ARRY-520 has been well tolerated with no peripheral neuropathy and limited non-hematologic toxicity.  Adverse events are generally limited to transient, non-cumulative and predominantly asymptomatic hematologic effects.Based on the strength of data from ongoing or completed clinical trials, and recent positive discussions with the Food and Drug Administration (FDA), Array expects to initiate a global Phase 3 study of ARRY-520 in patients with relapsed and refractory multiple myeloma (RRMM), of which there are more than 70,000 patients in developed countries.   The trial will evaluate ARRY-520 in several hundred patients with RRMM, comparing Kyprolis plus ARRY-520 to Kyprolis alone, with Progression Free Survival (PFS) as the primary endpoint.  Key secondary endpoints include Overall Survival (OS) and safety and efficacy differences between patients with low- and high-levels of alpha-1-acid glycoprotein (AAG), a potential patient selection marker.  The trial design may include an interim analysis of Objective Response Rate (ORR), which if positive, could support an accelerated regulatory filing.Array plans to conduct two clinical studies in addition to the Phase 3 trial.  The first is a randomized Phase 2 trial comparing Kyprolis plus ARRY-520 versus Kyprolis alone in 75 RRMM patients with PFS as the primary endpoint.  This trial, which is expected to begin next month, is designed to provide near-term confirmation of the combinability observed in the ongoing MD Anderson ARRY-520 plus Kyprolis trial.  Posit
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