ArQule and Daiichi Sankyo drop tivantinib trial in NSCLC

USA-based drug developer ArQule (Nasdaq: ARQL) saw its shares plunge 62% to $1.90 after, along with its partner Japan’s Daiichi Sankyo (TYO: 4568), announced they were halting a Phase III study in non-small cell lung cancer (NSCLC) of its  tivantinib after independent monitors concluded the drug would not meet its endpoint of prolonging overall patient survival.

The MARQUEE (Met inhibitor ARQ 197 plus Erlotinib vs Erlotinib plus placebo in NSCLC) trial, although showing a statistically significant improvement in progression-free survival (PFS) in the intent-to-treat (ITT) population, this benefit did not carry over to overall survival. There were no safety concerns identified by the DMC to Daiichi Sankyo or ArQule during this interim analysis.

MARQUEE is a randomized, double-blind, controlled pivotal trial to evaluate the investigational selective MET inhibitor, tivantinib (ARQ 197), in combination with erlotinib in previously treated patients with locally advanced or metastatic, non-squamous NSCLC.