Why ArQule Inc. Shares Surged in After-Hours Trading

Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.

What: Shares of ArQule (NASDAQ: ARQL  ) , a clinical-stage biopharmaceutical company developing cancer therapies, surged 26% in after-hours trading as of this writing after providing an update on clinical trials for hepatocellular carcinoma and non-squamous non-small cell lung cancer utilizing tivantinib.

So what: With regard to its phase 3 METIV-HCC trial, which is being conducted with partner Daiichi Sankyo, the data monitoring committee has recommended it continue the trial at the lower 120 mg dose. Analysis conducted by the DMC noted a reduction in neutropenia at the lower dose, yet similar plasma exposure, meaning little effect on effectiveness, in theory. For the phase 3 ATTENTION trial of metastatic non-squamous NSCLC in Japan, the 307 patient trial results showed a median overall survival of 12.9 months when tivantinib was administered with erlotinib compared to 11.2 months in the erlotinib arm by itself. However, this difference was not considered to be statistically significant. To add, enrollment in this trial was initially stopped in October 2012 after a trial safety committee review noted an increased number of interstitial lung disease cases (ILD). No ILD imbalances have been noted in the MARQUEE trial underway in the Western countries.

Now what: It's certainly a mixed bag of data in the after hours with tivantinib providing some leanings of a clinical benefit in non-squamous NSCLC, but not to the point of statistical significance. The big point that investors seem to be grasping is new data that would allude to tivantinib being more tolerable than previously thought. A lower dose in the liver cancer trial with similar effect would certainly give the drug a more favorable safety profile, while trial results lacking ILD cases in other Western countries might produce better overall survival and/or progression-free survival results. I'm personally not sold on tivantinib's efficacy just yet, but we're getting close to the point where we'll have the data to make that determination.

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