Daiichi Sankyo and ArQule have announced that a Phase II study of tivantinib (ARQ 197) used in combination with irinotecan and cetuximab in patients with refractory or relapsed colorectal cancer (CRC) did not meet the primary endpoint of progression-free survival (PFS).

According to the top-line results, Tivantinib, in combination with irinotecan and cetuximab, demonstrated a trend of prolonged PFS and improved objective response rate (ORR) in the signal generation trial.

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Daiichi Sankyo clinical development-oncology vice president Reinhard von Roemeling said the findings expand the body of data for tivantinib in CRC and offer the potential for further exploration.

"According to the top-line results, Tivantinib, in combination with irinotecan and cetuximab, demonstrated a trend of prolonged PFS and improved objective response rate (ORR) in the signal generation trial."

"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," Reinhard von Roemeling said.

The analysis of the patients enrolled 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).

ORR, a secondary endpoint, was 45% in the experimental arm against 33% in the control arm, which was not statistically significant.

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The PFS results obtained in both the arms were longer than expected compared to previously published historical norms.

The adverse events profile in the study, in which Tivantinib combination therapy was generally well tolerated, 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.