(Reuters) - ArQule Inc and Japan's Daiichi Sankyo Co Ltd said a mid-stage trial of their colorectal cancer drug failed to meet the main study goal of improving patient survival without the cancer getting worse, sending ArQule's shares tumbling before the bell.
ArQule shares were down 23 percent at $2.25 before the bell. They closed at $2.92 on Thursday on the Nasdaq.
The trial, which enrolled 122 patients with refractory or relapsed colorectal cancer, also failed to meet the secondary goal of showing improved response to the drug.
Patients were either given the drug, tivantinib, twice daily, in combination with older cancer drugs irinotecan and cetuximab, or placebo plus irinotecan and cetuximab.
The drug improved patients' progression-free survival (PFS), or survival without the cancer growing, but the improvement was not statistically significant.
PFS was 8.3 months for patients treated with the drug, compared with 7.3 months for those receiving a placebo.
ArQule tied up with Daiichi Sankyo in December 2008 to co-develop tivantinib in the United States, Europe, South America and other regions.
The companies plan to continue discussions with colorectal cancer experts to determine how to proceed with further development of the drug for this cancer, Daiichi said.
(Reporting by Esha Dey in Bangalore; Editing by Supriya Kurane)