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Daiichi, ArQule cancer drug tivantinib flunks another trial

Fails to meet endpoint in colorectal cancer study

A candidate drug for colorectal cancer in development at Daiichi Sankyo and ArQule has failed to meet its primary endpoint in a phase II trial.

The drug, called tivantinib (ARQ 197), was unable to meet the target of prolonging progression-free survival (PFS) in patients during the course of the study, which involved individuals with refractory or relapsed colorectal cancer.

Tivantinib is a first in-class inhibitor of MET, a receptor tyrosine kinase thought to play a role in the development of a number of human cancers. It is one of the first to emerge from a cancer collaboration between Daiichi and ArQule, which started in 2008.

The phase II study looked at tivantinib or placebo given on top of treatment with irinotecan and Bristol-Myers Squibb/Eli Lilly/Merck KGaA's Erbitux (cetuximab) in 122 patients with unresectable colorectal cancer whose tumours expressed the wild-type form of the KRAS gene.

PFS was 8.3 months in patients treated with tivantinib, compared with 7.3 months in those in the placebo group, which was not a statistically significant difference.

The data also showed that the addition of tivantinib to irinotecan and Erbitux did not significantly improve the objective response rate versus placebo – a secondary goal of the trial – although the company said for both endpoints there was a trend towards improvement with its drug.

Shares in ArQule closed down more than 11 per cent on Friday on the announcement, as investors digested the news that tivantinib had failed in a second study.

Last October, the company reported that the phase III MARQUEE trial of tivantinib in non-small cell lung cancer (NSCLC) had been stop prematurely after an interim analysis made it clear it would not meet its objective of showing an improvement in overall survival, although it said at the time the data had revealed a "strong PFS signal".

The drug fared rather better in a phase II trial in hepatocellular carcinoma (HCC), where it showed an improvement in time to progression, progression free survival and overall survival in the MET-positive HCC patients.

Daiichi's vice president of oncology clinical development, Reinhard von Roemeling, said the two companies will "continue discussions with key opinion leaders in the field of CRC to determine how best to proceed with further clinical development of tivantinib in this tumour type ".

14th January 2013

From: Research

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