Daiichi Sankyo Company, Limited (TSE 4568) and ArQule, Inc. (Nasdaq: 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 the control arm but was not statistically significant. The PFS results obtained in both the control arm and the experimental arm were longer than expected compared to previously published historical norms. Additional data and analyses from this trial are planned for presentation at a future medical meeting and will include mature OS data as well as analyses of patient sub-groups, biomarker status and regional variability, including pre- and post study treatments. “We are encouraged by these findings that expand the body of data for tivantinib in CRC and offer the potential for further exploration,” said Reinhard von Roemeling, M.S., Vice President, Clinical Development-Oncology, Daiichi Sankyo. “We plan to continue discussions with key opinion leaders in the field of CRC to determine how best to proceed with further clinical development of tivantinib in this tumor type.” Adverse events were reported at similar rates in the experimental and control arms, except for increased neutropenia observed in the experimental arm, with no discontinuations of treatment for this reason. No treatment-emergent adverse events leading to death were assessed as related to study treatment. Tivantinib was generally well tolerated in combination with the doses of cetuximab and irinotecan studied in this trial.