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ArQule, Daiichi Sankyo: Tivanitinib didn't meet primary Phase 2 trial endpoint

Daiichi Sankyo and ArQule announced the top-line results of a randomized Phase 2 signal generation trial of tivantinib used in combination with irinotecan and cetuximab in patients with refractory or relapsed colorectal cancer. Although the trial did not meet its primary endpoint of Progression-Free Survival, the analysis of the patients enrolled showed that median PFS was 8.3 months in the experimental arm, compared with 7.3 months in the control arm. Objective Response Rate 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.”