ArQule ($ARQL) suffered another failure with its top anti-cancer contender tivantinib. This time the experimental kinase inhibitor fell short in a midstage study in patients with aggressive cases of colorectal cancer, a fresh setback in a program already injured from efficacy concerns.
Shares of ArQule sank more than 20% in pre-market trading after the news hit the wires. The price was $2.32 as of 8:42 a.m. ET.
The Boston-area drug developer's shares have lost more than half their value in the past half year as the company and partner Daiichi Sankyo have turned in disappointing results from their out ambitious tivantinib program. In October the pair disappointed investors with a Phase III failure in patients with non-small cell lung cancer, falling short on improvement in overall survival while boosting progression-free survival (PFS).
In the 122-patient Phase II study in colorectal cancers, the partners saw patients on tivantinib as well as irinotecan and cetuximab survive without their cancer worsening (or PFS) for 8.3 months compared with 7.3 months in patients on the latter two meds alone. One more month didn't cut it. Nor did the 45% objective response rate in the experimental arm versus the 33% in the control arm.
Daiichi Sankyo's Reinhard von Roemeling stated in a release that his company "encouraged" by results of the study. The company's plan to present overall survival data in the future. For now, ArQule is off to rough start in 2013 with its lead program weakened with more disappointing data.
- here's the release
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ArQule disappoints with failed Phase II colon cancer study. Given the approach, was this one destined to fail?
With input from @RyanMFierce