--Companies end late-stage trial of lead drug candidate
tivantinib
--Independent committee concludes trial wouldn't meet goals
--ArQule shares down 56%
ArQule Inc. (ARQL) and Daiichi Sankyo Co. (DSNKY, 4568.TO) said
they would discontinue their late-stage study of a drug to treat
lung cancer because of futility, a severe setback for ArQule's lead
product candidate.
Shares of ArQule plunged 56% to $2.20.
ArQule made the decision after an independent committee
concluded the study wouldn't meet its primary goals of improved
overall survival.
The trial evaluated the use of tivantinib, ArQule's lead product
candidate, in combination with erlotinib to treat patients with
certain forms non-small-cell lung cancer.
In 2008, ArQule and Daiichi Sankyo agreed to co-develop
tivantinib in the U.S., Europe, South America and the rest of the
world, excluding Japan, China, South Korea and Taiwan.
"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,
global head of research and development at Daiichi Sankyo.
ArQule is enrolling patients for a late-stage study of
tivantinib in HCC liver-cancer patients, said Chief Executive Paolo
Pucci in a conference call with investors. The trial should begin
late this year or in early 2013.
In August, ArQule said partner Kyowa Hakko Kirin Co. (4151.TO)
temporarily suspended patient enrollment in a separate late-stage
study of tivantinib, causing ArQule's shares to drop sharply.
ArQule is studying tivantinib in several early- and mid-stage
trials, including in lung cancer with KRAS mutations and colorectal
cancer. Results from those trials are expected in mid-2013 and the
first quarter of next year, said George Zavoico, a senior analyst
at MLV & Co.
Write to Ben Fox Rubin at Ben.Rubin@dowjones.com and Joseph
Walker at Joseph.Walker@dowjones.com
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