Shares of ArQule, Inc, (ARQL) were up 37.71% on data from two phase III trials – METIV-HCC and ATTENTION.
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 Roche’s (RHHBY) 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 survival.
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 indications.
ArQule currently carries a Zacks Rank #3 (Hold). Right now, Questcor Pharmaceuticals (QCOR) and Forest Laboratories Inc. (FRX) look attractive with a Zacks Rank #2 (Buy).
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