Daiichi's lung cancer drug progresses to phase III

Daiichi Sankyo and biotech firm Arqule are to move their lung cancer treatment ARQ 197 into phase III trials.

The oral treatment is an inhibitor of receptor tyrosine kinase which acts on the epidermal growth factor receptor (EGFR).

Roche’s Tarceva (erlotinib) has become a new front line treatment of NSCLC, and also blocks EGFR.

ARQ 197 offers something new because it blocks c-Met receptor, a protein thought to be closely involved in the growth and spread of cancer cells.

The phase III trials will test ARQ 197 plus Tarceva against placebo plus Tarceva.

Global head of R&D unit for Daiichi Sankyo, Dr Kazunori Hirokawa said: “The efficacy observed among patients with NSCLC who received ARQ 197 provides us with encouraging evidence that ARQ 197 may be beneficial to this patient population.”

The companies have now filed a request to conduct the trial with the FDA using a Special Protocol Assessment (SPA).

He added: “Based on these results, we are developing plans to support a phase III clinical programme and bring new hope to patients with this disease.”

Paolo Pucci, Arqule’s chief executive added: “The decision to advance ARQ 197 into Phase III clinical testing underscores the success of our partnership with Daiichi Sankyo.

“ArQule and Daiichi Sankyo signed the ARQ 197 partnership 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.”

Brett Wells