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Daiichi Sankyo Co Ltd and ArQule, Inc. Announces Top-Line Results Of Phase 2 Trial With Tivantinib in Colorectal Cancer

Friday, 11 Jan 2013 07:30am EST 

Daiichi Sankyo Co Ltd and ArQule, Inc. announced 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 trial did not meet primary endpoint of Progression-Free Survival (PFS), analysis of 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 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% in the experimental arm versus 33% in control arm but was not statistically significant. The PFS results obtained in both control arm and the experimental arm were longer than expected compared to previously published historical norms. The 122 patients enrolled in this trial (US n=67;Russia n=39; Western Europe n=16) had unresectable CRC, progressed following first-line treatment and had tumors expressing wild-type form of the KRAS gene. The primary objective of trial was to assess contribution of tivantinib to irinotecan and cetuximab treatment regimen. The primary endpoint of study was PFS, and secondary objectives included OS and ORR. Patients were randomized to receive tivantinib, 360 milligrams twice daily, plus irinotecan and cetuximab, or placebo plus irinotecan and cetuximab. 

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