ArQule Announces Interim Phase 2 Study Results For Tivantinib - Quick Facts

(RTTNews) - ArQule Inc. (ARQL) announced interim data from an ongoing investigator-initiated Phase 2 clinical trial with tivantinib in combination with cetuximab in patients with MET-High, KRAS wild-type metastatic colorectal cancer or CRC NCT01892527 who recently progressed on anti-EGFR antibodies.

The primary endpoint of the trial is ORR in the biomarker defined population. Secondary study endpoints are progression-free survival or PFS, overall survival or OS and safety. The ESMO World GI presentation included data from 21 patients enrolled in Stage 1 of this trial. One patient, still on therapy, experienced a complete response or CR and 2 patients experienced durable confirmed partial responses or PRs.

Stable disease was observed in 8 patients, including 2 short duration PRs, for an overall Disease Control Rate (CR + PR + SD) of 52.4%. Having met the Stage 1 endpoint (=2 confirmed responses), the trial continued to Stage 2 and has recently completed enrollment.

Adverse events were in line with those historically reported, including skin toxicity attributed to cetuximab, and neutropenia attributed to tivantinib. Neutropenia was addressed timely with growth factors and dose adjustments.

The trial is a 2-stage, investigator-initiated study testing tivantinib plus cetuximab after recent progression on anti-EGFR antibodies. The trial is coordinated by the Humanitas Cancer Center in Milan, Italy. Stage 1 enrolled 21 patients, and Stage 2 recently completed enrollment of 20 additional patients. Final results from the 41 patients enrolled are expected by the end of 2015.