Daiichi Sankyo and partner ArQule have announced plans to put an investigational lung cancer into late-stage trials.

The firms are hoping to start a Phase III clinical trial of ARQ 197, a small molecule inhibitor of the c-Met receptor tyrosine kinase, in patients with non-small cell lung cancer. Specifically the Japanese drugmaker will file a special protocol assessment (SPA) with the US Food and Drug Administration for a study comparing the compound plus Roches Tarceva (erlotinib) with the Swiss major’s drug plus placebo.

This decision follows “the completion of a comprehensive review of clinical and pre-clinical data, including discussions with key opinion leaders and a meeting with the FDA following the recently completed Phase II trial,” ArQule noted. In the latter, treatment with ARQ 197 in combination with erlotinib showed promising overall survival and progression-free survival among patients with advanced, refractory NSCLC.

Kazunori Hirokawa, global head of R&D at Daiichi Sankyo, said the trial “provides us with encouraging evidence that ARQ 197 may be beneficial to this patient population”. ArQule chief executive Paolo Pucci said the move into Phase III “underscores the success of our partnership with Daiichi Sankyo,” as the firm only teamed up in December 2008 and “in less than two years, we are requesting an SPA for a Phase III trial with this potential first-in-class molecule”.

An SPA is an agreement with the FDA establishing the design, endpoints and statistical analysis of a clinical trial intended to provide the necessary data to support a New Drug Application (NDA). Following FDA review of the SPA, the two companies will implement the protocol for the Phase 3 trial and commence patient enrollment. Details regarding the trial design will be communicated at that time.