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