ArQule announces ARQ 197 Phase 2 clinical trial results at ESMO annual meeting

ArQule, Inc. (NASDAQ: ARQL) today announced the presentation of final results from a Phase 2 clinical trial in non-small cell lung cancer (NSCLC) of ARQ 197, a selective small molecule inhibitor of the c-MET receptor tyrosine kinase, at the annual meeting of the European Society for Medical Oncology (ESMO).

“We believe these findings are of clinical significance and reflect the biological involvement of c-MET in cancer cell metastasis and resistance to treatment with EGFR inhibitors such as erlotinib.”

The presentation included new exploratory data analyses related to the anti-metastatic effect of ARQ 197 observed in this trial. Patients treated with ARQ 197 plus erlotinib had a median time to develop new metastases of 7.3 months, compared to 3.6 months for patients treated with erlotinib plus placebo. This effect was more pronounced among patients with non-squamous cell histology, among whom the median time to develop new metastases was 11.0 months for patients treated with ARQ 197 plus erlotinib, compared with 3.6 months for those treated with erlotinib plus placebo.

"The metastases-delaying data from this trial further strengthen our mechanistic understanding of the anti-cancer effect of ARQ 197," said Brian Schwartz, M.D., chief medical officer of ArQule. "We believe these findings are of clinical significance and reflect the biological involvement of c-MET in cancer cell metastasis and resistance to treatment with EGFR inhibitors such as erlotinib."

As previously announced, data from this trial showed promising overall survival and progression-free survival among patients with advanced, refractory NSCLC treated with ARQ 197 in combination with erlotinib.

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