Daiichi Sankyo and ArQule Announce Phase 2 Trial with Tivantinib in Colorectal Cancer Did Not Meet Primary Endpoint

Daiichi Sankyo Company, Limited (TSE 4568) and ArQule, Inc.

today announced the top-line results of a randomized Phase 2 signal generation trial of tivantinib (ARQ 197) used in combination with irinotecan and cetuximab in patients with refractory or relapsed colorectal cancer (CRC). Although the trial did not meet its primary endpoint of Progression-Free Survival (PFS), the analysis of the patients enrolled (n=122) showed that median PFS was 8.3 months in the experimental arm (patients treated with irinotecan and cetuximab plus tivantinib), compared with 7.3 months in the control arm (patients treated with irinotecan and cetuximab plus placebo) (hazard ratio = 0.85, 95% CI: 0.55, 1.33). Objective Response Rate (ORR), a secondary endpoint, was 45 percent in the experimental arm versus 33 percent in