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Daiichi and ArQule pull late-stage study of lung cancer drug

Fails to reach primary endpoint of overall survival

Daiichi-Sankyo and ArQule have pulled a phase III trial investigating tivantinib (ARQ 197) in the treatment of non-small cell lung cancer (NSCLC).

An independent data monitoring committee recommended the companies halt development following an interim analysis of the trial, which concluded the drug would not reach its primary endpoint of improved overall survival in patients.

The decision saw ArQule's shares drop as much as 60 per cent, with the company's lead product now seemingly without a future in its main intended indication.

Paolo Pucci, chief executive officer of ArQule, said he was “disappointed” the trial did not meet its main goal, despite demonstrating a statistically significant improvement in progression-free survival in the intent-to-treat population.

Following its original discover by Arqule, the drug was the subject of a 2008 agreement with Daiichi to co-develop and co-commercialise the product in all countries excluding Japan, China, South Korea and Taiwan.

It had initially shown promise as a c-Met inhibitor, and the phase III MARQUEE trial was investigating its use alongside Roche's Tarceva (erlotinib) in patients with previously treated, unresectable, locally advanced or metastatic, non-squamous NSCLC.

There is a further ongoing trial called ATTENTION that is investigating tivantinib 460 patients with previously treated, locally advanced or metastatic, non-squamous NSCLC with wild-type EGFR mutation. Again, the primary endpoint of this study is overall survival.

Dr Glenn Gormley, global head, R&D and senior executive officer, Daiichi, also said there was still a possible future for the treatment.

“Fighting cancer is a complex process in that therapies work differently in different tumour settings, so we will continue to investigate tivantinib in other tumour types.”

3rd October 2012

From: PME

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