) continues to focus its efforts on developing lead candidate
tivantinib (ARQ 197) after having suffered a few setbacks earlier
in the year.
We note that ArQule is developing tivantinib in collaboration
with Japanese company Daiichi Sankyo. ArQule currently does not
have any marketed product in its portfolio and tivantinib is its
most advanced stage candidate, which is being developed for a
variety of indications.
ArQule presented encouraging data from a randomized,
double-blind, placebo-controlled phase III trial, MARQUEE, at the
European Cancer Congress.
The data showed the clinical benefits of treatment with the
combination of tivantinib and
) Tarceva (erlotinib) in patients suffering from non-squamous,
non-small cell lung cancer (NSCLC) whose tumors expressed high
levels of MET protein.
The final analysis of data from the MARQUEE trial showed
tivantinib was significantly effective in treating MET High NSCLC
patients and showed improvements in both overall survival (OS)
and progression free survival (PFS).
However, patients with MET Low NSCLC did not experience
significantly improved OS despite their increased PFS.
We remind investors that ArQule suffered a setback when the
MARQUEE trial was stopped in Oct 2012 after a planned interim
analysis. The independent Data Monitoring Committee (DMC) had
recommended that the study should be discontinued as it was not
likely to meet its primary endpoint of improved overall
Subsequently, the trial was allowed to be continued in
patients, whose disease had not yet progressed after the interim
analysis. The data cut-off for full study analysis was Dec 15,
Although the trial has been stopped, ArQule and Daiichi Sankyo
will consider the full analysis of data from the MARQUEE trial
and other studies and thereafter decide on the further
development of tivantinib for the NSCLC indication or in certain
biomarker-defined sub-groups within the diseased population.
Meanwhile, ArQule is also evaluating tivantinib for the
treatment of hepatocellular cancer.
We expect investor focus to remain on further updates on
tivantinib from the different trials being conducted.
ArQule currently carries a Zacks Rank #3 (Hold). Right now,
) look attractive. While Jazz Pharma carries a Zacks Rank #1
(Strong Buy), Cempra carries a Zacks Rank #2 (Buy).
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