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Array BioPharma Reports Financial Results for the Third Quarter of Fiscal 2013
Date:5/6/2013

rnational Myeloma Workshop in April, Array presented interim results from an ongoing ARRY-520 plus Velcade combination trial, as well as results from a Phase 2 ARRY-520 single agent trial.  For patients in the combination trial, the treatment was generally well-tolerated.  Neutropenia was the most common adverse event, but was transient, non-cumulative, predominantly asymptomatic and well managed with use of growth factor support.  Incidence of non-hematologic grade 3/4 toxicity was infrequent.  Initial signs of activity, including responses and prolonged stable disease, were observed in this heavily pretreated population, the majority (72%) of whom were refractory to prior Velcade treatment.  This study will further investigate the addition of low-dose dexamethasone and an alternative dosing schedule of ARRY-520.

Final results from the Phase 2 single agent trial demonstrated clinical activity in heavily pre-treated patients.  ARRY-520 demonstrated single agent activity in heavily pretreated patients, with 19 months median Overall Survival and a 16% Overall Response Rate.  These results are similar to those for recently approved products Kyprolis® (carfilzomib) and Pomalyst® (pomalidomide) as single agents in a similar patient population.  ARRY-520 was generally well tolerated, with the most-common adverse events being transient and non-cumulative neutropenia and thrombocytopenia that were readily managed with growth factors and supportive care. In addition, there were infrequent reports of serious adverse events such as febrile neutropenia or sepsis.  Consistent with other reported ARRY-520 study results, there was a low incidence of non-hematologic adverse events with no treatment-related neuropathy observed.  Further data on a potential patient selection marker was also presented.  Patients with normal levels of alpha-1-acid glycoprotein (AAG) had a longer median overall survival (20.2 months
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