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ArQule, Inc. (ARQL - Snapshot Report) 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 Sankyo.

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 patient population.

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 terminations.

We note that ArQule currently does not have any marketed product in its portfolio and tivantinib is its most advanced stage candidate.

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 trial. 

ArQule currently carries a Zacks Rank #3 (Hold). Right now, Jazz Pharmaceuticals (JAZZ - Analyst Report), Ironwood Pharmaceuticals (IRWD - Analyst Report), and Forest Laboratories Inc. look attractive with a Zacks Rank #2 (Buy).

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