Data on ArQule's Tivantinib

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ArQule (ARQL) 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 Roche’s (RHHBY) 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 survival. 

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, 2012.

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, Jazz Pharmaceuticals (JAZZ) and Cempra, Inc. (CEMP) look attractive. While Jazz Pharma carries a Zacks Rank #1 (Strong Buy), Cempra carries a Zacks Rank #2 (Buy).

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