ArQule ($ARQL) and its partner Daiichi Sankyo revealed some depressing news about their late-stage program for the closely watched cMET inhibitor called tivantinib or ARQ 197 in patients with non-small cell lung cancer. The partners have stopped a major Phase III study early after a data monitoring committee saw no hope for the study to meet its primary goal for improving overall survival.
Woburn, MA-based ArQule's shares tanked in premarket trading, down more than 65% as of 8 a.m. ET.
ArQule is feeling the hurt of seeing a key study for its lead product candidate go down in flames. The late-stage "Marquee" study recruited about 1,000 patients with aggressive NSCLC and tested a combination of its ARQ 197 and Roche's ($RHHBY) approved Tarceva (erlotinib) against Tarceva and placebo. While interim data showed the new drug helped patients live longer without their cancer worsening, the success wasn't seen in the key OS category.
"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 Dr. Glenn Gormley, global head of R&D and senior executive officer at Daiichi Sankyo.
This is the latest bump in the road for tivantinib. Kyowa Hakko, which has rights to the drug in Japan and other parts of Asia, gave ArQule's investors a scare in late August when it temporarily hit the brakes on enrollment in its Phase III study of the drug for treating NSCLC patients over toxicity concerns, prompting its U.S. partner's share price to fall. This latest setback in the partnership with Daiichi--ArQule's partner for the rest of the world--leaves ArQule CEO Paolo Pucci with the challenge of selling investors on the promise of his company's pipeline.
- here's the release