) were up 37.71% on data from two phase III trials - METIV-HCC
ArQule is evaluating tivantinib (ARQ 197) for the treatment of
hepatocellular carcinoma (liver cancer) in the METIV-HCC trial in
collaboration with Daiichi Sankyo Co., Ltd. The primary endpoint
of the study is overall survival while the secondary endpoint is
progression free survival.
We remind investors that in Sep 2013, the Data Monitoring
Committee (DMC), of the METIV-HCC trial recommended that the
study dosage should be brought down from 240 mg twice daily to
120 mg twice daily after a higher incidence of neutropenia was
observed in the patient population in the phase III trial
compared to the phase II trial.
The recent analysis from the study showed that the incidence
of neutropenia was reduced in patients treated with 120 mg
tivantinib tablets, administered twice daily.
Meanwhile, ArQule is also conducting an amended phase III
trial, ATTENTION, evaluating the combination of tivantinib and
) Tarceva in patients with advanced or metastatic non-squamous
non-small cell lung cancer (NSCLC) with wild-type EGFR (epidermal
growth factor receptor) in Asia (Japan, Korea and Taiwan).
We remind investors that ArQule suffered a setback when the
MARQUEE trial was stopped in Oct 2012 after a planned interim
analysis. The trial was evaluating 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).
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
Hence, the trial was amended. The data from the trial showed
that overall survival (OS) favored the treatment arm of
tivantinib plus Tarceva as compared to Tarceva only control arm,
but it was not statistically significant.
We note that 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
ArQule currently carries a Zacks Rank #3 (Hold). Right now,
Forest Laboratories Inc
) look attractive with a Zacks Rank #2 (Buy).
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