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news.Daiichi Sankyo Company and ArQule have reported top-line results of Phase 2 signal generation trial of tivantinib used in combination with irinotecan and cetuximab conducted in refractory or relapsed colorectal cancer (CRC) patients.
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The randomized trial did not meet its primary endpoint of progression-free survival (PFS).
According to the analysis of patients enrolled, median PFS was 8.3 months in the experimental arm compared to 7.3 months in the control arm.
A secondary endpoint, objective response rate (ORR) was 45% in the experimental arm against 33% in the control arm but was not statistically significant.
Daiichi Sankyo clinical development-oncology vice president Reinhard von Roemeling said, "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."
PFS results obtained in both the arms were longer than expected compared to previously published historical norms, according to the company.
Study reported similar adverse event profile in the experimental and control arms, except for increased neutropenia observed in the experimental arm.