ArQule initiates Phase I/II trial for lung cancer drug

The non-small cell lung cancer (NSCLC) program consists of two trials. The first is a Phase I trial in which investigators will determine the safety, tolerability and a recommended Phase II dose of ARQ 197 when administered in combination with erlotinib in this patient population. Secondarily, investigators will evaluate the pharmacokinetic profile and assess the preliminary anti-tumor activity of this combination therapy.

Pending the completion of Phase I, the company plans to initiate a Phase II trial, designed as a multi-center, placebo controlled, randomized trial comparing ARQ 197 plus Tarceva against placebo plus Tarceva.

Peter Lawrence, COO of ArQule, said: “The high level of interest in this particular indication within the oncology community has been generated by scientific data showing that the development of resistance in NSCLC tumors to therapy with EGFR (epidermal growth factor receptor) inhibitors may be linked to an increase in c-Met signaling. Overcoming such resistance has been a challenge, and we believe the inhibition of c-Met may offer a new strategy in treating these tumors and extending the lives of patients.”