Phase 1 Results of ARQ 197 c-MET Inhibitor in Colorectal Cancer Presented at ASCO 2011 Gastrointestinal Cancers Symposium
WOBURN, Mass.--(BUSINESS WIRE)-- 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.
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
I thought these early results looked good and the stock would react positively today.
"To date, two pts have discontinued (1 disease progression and 1 withdrew consent after achieving complete response) and 7 pts remain on study. The reported grade 3/4 adverse events were: neutropenia (3/4: 1/1), and one case each of grade 3 fatigue, leucopenia, acneiform rash, vomiting, anemia and syncope. Preliminary efficacy data in 9 evaluable pts include 1 CR (after 4 cycles), 2 PR (after 2 cycles), 5 SD, and 1 PD as best response."
8 out of 9 have stable progression or better. Can anyone provide additional insight?
The irinotecan and cetuximab (erbitux) is a nasty combo with many side-effects but it improves OS and shrinks tumors in good many patients.
The irinotecan and erbitux combo treatment in 2-line mCRC is poorly understood. But Erbitux has close to $2B worldwide sale. Erbitux is approved in - mCRC in all lines with different chemo - H&N with RT and chemo - Lung cancer in EU only
The bottom line for ARQ 197 in mCRC - Promise is there - a PhII with a control arm (IRA+Erbitux) is required to make any conclusions - Erbitux now belongs to LLY but all clinical trials are done by Merck KGaA from Germany.