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Array BioPharma Inc.
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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