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

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Array BioPharma Inc.
ARRY
today announced that interim results from an ongoing ARRY-520 clinical trial in multiple myeloma (MM) were presented at the 2013 Congress of the European Hematology Association in Stockholm, Sweden. Also at the meeting, Array presented updated information on a potential patient selection marker for ARRY-520.  ARRY-520 is a highly selective, targeted inhibitor of KSP with a mechanism of action distinct from other drugs used to treat MM that continues 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 Patients with 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 refractory or intolerant to Velcade® (bortezomib) were reported.  The combination has demonstrated early signals of activity with a disease control rate (complete response, partial response, minimal response or stable disease) of 82% and a clinical benefit rate (≥minimal response) of 53%, including one complete response.  In addition, the combination has been well tolerated with no unexpected hematologic toxicity and a manageable side effect profile.  More than half of the patients enrolled remain on study, with patients in the current cohort receiving full doses of both drugs without reaching a maximum tolerated 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 to be additive relative to the observed events for either drug alone," said Jatin J. Shah, M.D., Assistant Professor, Lymphoma/Myeloma, Division of Cancer Medicine, The University of Texas, MD Anderson Cancer Center. "While this is an ongoing study, and we await mature data, there have been promising signs of activity in a heavily pretreated population, which includes several patients previously exposed to ARRY-520 or carfilzomib." Alpha 1-Acid Glycoprotein (AAG) is a Potential Patient Selection Marker for Clinical 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 multiple studies of ARRY-520 in patients with relapsed and refractory multiple myeloma.  To date all responses have occurred in patients with low levels of alpha-1-acid glycoprotein (AAG) and these patients had longer event free survival (time to next treatment or death).  In a single-agent Phase 2 ARRY-520 clinical study, the median overall survival was reported to be markedly 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 of patient populations who will benefit from ARRY-520. 
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