WOBURN, Mass. (
(ARQL - Get Report)
shut down a late-stage lung cancer study of tivantinib after independent monitors concluded the drug would not prolong patient survival.
Arqule shares plunged $3.09, or 62%, to $1.90 in Tuesday's pre-market session.
At its current burn rate, Arqule has approximately $1.75 per share in cash.
The phase III "MARQUEE" study enrolled 1,000 patients with newly diagnosed non-small cell lung cancer and randomized them to receive either tivantinib plus Tarceva or Tarceva alone. Tarceva is a currently approved treatment for lung cancer marketed by
After a planned interim analysis, independent monitors concluded that tivantinib would fail to improve overall survival compared to Tarceva -- the primary endpoint of the study.
On that basis, Arqule and its partner Daiichi Sankyo decided to discontinue the study.
"We are disappointed that the MARQUEE trial did not provide statistically significant results for overall survival in a disease and treatment setting which remains a major unmet medical need," said Paolo Pucci, Arqule CEO, in a statement.
Arqule said nothing Tuesday about the status of a separate phase III study of tivantinib being conducted in Asia. That study, known as "ATTENTION"
stopped enrolling patients
in August due to reports of suspected cases if interstitial lung disease that appeared to be more prevalent in patients treated with tivantinib.
-- Reported by Adam Feuerstein in Boston.