) recently suffered a setback when it received a letter from the
Data Monitoring Committee (DMC) recommending a lower dose in the
ongoing phase III trial (METIV-HCC) on pipeline candidate
tivantinib (ARQ 197).
ArQule is evaluating tivantinib for the treatment of
hepatocellular cancer (HCC). We note that ArQule is developing
tivantinib in collaboration with Japanese company Daiichi
Initiated in early 2013, the METIV-HCC trial is evaluating
previously treated patients with MET-high inoperable HCC (liver
cancer) who will receive tivantinib as a single agent or placebo.
The primary endpoint of the study is overall survival while the
secondary endpoint is progression free survival.
The letter from the DMC 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 phase II study was also conducted on the same
Moreover, DMC also recommended the institution of better
patient monitoring procedures for confirming the safety profile
of the 120 mg dosage of the candidate.
Both ArQule and Daiichi Sankyo have accepted the DMC's
recommendation for a lower dose and will file a protocol
amendment with the regulatory authorities and related parties.
The companies believe that the reduced dose will lower the
incidence of neutropenia observed in the METIV-HCC trial, thereby
resulting in better patient safety and fewer early patient
We note that ArQule currently does not have any marketed
product in its portfolio and tivantinib is its most advanced
Hence, a setback in the ongoing phase III trial on tivantinib
and a subsequent expected delay in recruitment due to the
amendment is a major disappointment for ArQule.
The news impacted ArQule's shares negatively. We expect
investor focus to remain on further updates from the
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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