Array BioPharma Reports Interim Results from Combo Trial of ARRY-520 with Kyprolis

Array BioPharma Inc. (NASDAQ: ARRY) today announced that interim results from an ongoing ARRY-520 clinicaltrial in multiple myeloma (MM) were presented at the 2013 Congress of theEuropean Hematology Association in Stockholm, Sweden. Also at the meeting,Array presented updated information on a potential patient selection markerfor ARRY-520.  ARRY-520 is a highly selective, targeted inhibitor of KSP witha mechanism of action distinct from other drugs used to treat MM thatcontinues to advance in clinical trials.(Logo: http://photos.prnewswire.com/prnh/20121029/LA02195LOGO)Phase 1 Study of the Novel KSP Inhibitor ARRY-520 + Carfilzomib in Patientswith Relapsed and/or Refractory Multiple Myeloma (RRMM) (Protocol #ARRAY-520-112)Interim data from an ongoing combination trial of ARRY-520 with Kyprolis®(carfilozomib) in patients with relapsed or refractory MM who are refractoryor intolerant to Velcade® (bortezomib) were reported.  The combination hasdemonstrated early signals of activity with a disease control rate (completeresponse, partial response, minimal response or stable disease) of 82% and aclinical benefit rate (≥minimal response) of 53%, including one completeresponse.  In addition, the combination has been well tolerated with nounexpected hematologic toxicity and a manageable side effect profile.  Morethan half of the patients enrolled remain on study, with patients in thecurrent cohort receiving full doses of both drugs without reaching a maximumtolerated dose (MTD)."To date, the combination of ARRY-520 with Kyprolis has been well tolerated. Reversible neutropenia is the most common adverse event and does not appear tobe additive relative to the observed events for either drug alone," said JatinJ. Shah, M.D., Assistant Professor, Lymphoma/Myeloma, Division of CancerMedicine, The University of Texas, MD Anderson Cancer Center. "While this isan ongoing study, and we await mature data, there have been promising signs ofactivity in a heavily pretreated population, which includes several patientspreviously exposed to ARRY-520 or carfilzomib."Alpha 1-Acid Glycoprotein (AAG) is a Potential Patient Selection Marker forClinical Activity of ARRY-520 in Relapsed and Refractory Multiple Myeloma (MM)(Protocol # ARRAY-520-212)Data on a potential patient selection marker was also presented from multiplestudies of ARRY-520 in patients with relapsed and refractory multiplemyeloma.  To date all responses have occurred in patients with low levels ofalpha-1-acid glycoprotein (AAG) and these patients had longer event freesurvival (time to next treatment or death).  In a single-agent Phase 2ARRY-520 clinical study, the median overall survival was reported to bemarkedly longer in patients with low AAG as compared to patients with high AAG(20.2 vs. 4.5 months). These results may enable more precise targeting ofpatient populations who will benefit from ARRY-520.