ArQule, Inc. (NASDAQ: ARQL) today announced the presentation of Phase 1 results of a clinical trial among patients with metastatic colorectal cancer (CRC) treated with ARQ 197, a selective small molecule inhibitor of the c-MET receptor tyrosine kinase, in combination with irinotecan and cetuximab. ARQ 197 is under development by Daiichi Sankyo Co., Ltd. and ArQule.
“These results provide important support for the ongoing Phase 2 randomized study of this combination”
Data presented at the ASCO 2011 Gastrointestinal Cancers Symposium showed that this combination was well tolerated and demonstrated encouraging anti-tumor activity in patients with relapsed metastatic CRC. Among nine patients treated, one had a complete response, two had partial responses and five had stable disease. The systemic exposure of ARQ 197 with this combination regimen was consistent with previous observations, and no dose-limiting toxicities were observed.
"These results provide important support for the ongoing Phase 2 randomized study of this combination," said Dr. Brian Schwartz, chief medical officer of ArQule. "We believe they strengthen the rationale for this study, which includes the previous demonstration of anti-cancer activity by ARQ 197 in a human colorectal cancer xenograft model, as well as the link shown between an increase in c-MET signaling and the development of resistance to therapy with epidermal growth factor receptor (EGFR) inhibitors."
The ongoing Phase 2 study of ARQ 197 in CRC is enrolling patients with the wild-type form of the KRAS gene who have received front-line systemic therapy. The primary objective of the trial is progression-free survival. Secondary objectives include overall survival and objective response rate. Approximately 150 patients will be enrolled at clinical trial sites in the U.S. and Europe. The trial is being conducted by Daiichi Sankyo Pharma Development, the global development arm of Daiichi Sankyo, the co-developer with ArQule of ARQ 197 outside of certain countries in Asia.
Additional cancers currently being evaluated in randomized trials of ARQ 197 as a single agent or in combination therapy include non-small cell lung cancer (Phase 3) and hepatocellular carcinoma (Phase 2). Patients, physicians and other healthcare professionals seeking additional information regarding these and other trials involving ARQ 197 may call 1-800-373-7827.
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