(Reuters) - Biotechnology company ArQule Inc and Japan's Daiichi Sankyo Co Ltd said they will discontinue a late-stage trial of their experimental lung cancer drug after an interim analysis showed it would not meet the main goal of improving overall survival.
"This is their single-most important asset. The drug may be dead, which may leave the company trading down to cash," said Chad Messer, an analyst with Needham & Company.
ArQule's shares were down 61 percent at $1.94 before the bell on Tuesday. They closed at $4.99 on Monday on the Nasdaq.
In August, Arqule's partner Kyowa Hakko Kirin Co, which holds development rights to tivantinib in parts of Asia, suspended patient enrollment in a late-stage trial for non small-cell lung cancer, sending Arqule's shares down 28 percent.
"Fighting cancer is a complex process in that therapies work differently in different tumor settings, so we will continue to investigate tivantinib in other tumor types," said Glenn Gormley, senior executive officer of Daiichi Sankyo.
While the interim analysis showed a statistically significant improvement in progression-free survival of patients on the drug tivantinib, the benefit did not carry to overall survival, the companies said in a statement.
Progression-free survival indicates a drug's effect on tumor growth, while overall survival is a more direct measure of a patient's chances of survival.
There were no safety concerns reported, according to the interim analysis.
The trial, named MARQUEE, tested tivantinib in combination with Roche Holding AG's FDA-approved drug Tarceva on 1,000 patients previously treated for non-small cell lung cancer, the most common type of lung cancer.
Tivantinib has not been approved for any indication in any country.
In December 2008, ArQule and Daiichi Sankyo signed an agreement to co-develop tivantinib in the U.S., Europe, South America and other countries.
(Reporting by Adithya Venkatesan in Bangalore; Editing by Sreejiraj Eluvangal and Roshni Menon)
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