Daiichi Sankyo and ArQule’s small molecule inhibitor Tivantinib has failed a phase 3 liver cancer trial, adding to the drug’s growing list of failures. 

Tivantinib had already failed in both lung and colorectal cancer in the past few years, and new data from its most recent application as a second-line treatment for hepatocellular carcinoma (HCC) indicate it has failed in liver cancer too.

The phase 3 trial failed to reach its primary endpoint of increased overall survival in a population of 340 patients with MET-overexpressing, inoperable HCC, or patients previously treated with systemic therapy.

MET is a molecule present in abnormally high levels in certain cancers and is responsible for an increase in tumour growth, metastasis and the formation of new blood vessels.

Data regarding whether the drug met its secondary endpoints of progression-free survival and safety were not disclosed.

“HCC is a disease with high unmet need, especially in the second-line setting, so these results are disappointing for the patients as well as the investigators and the companies,” said Paolo Pucci, CEO of ArQule.

“Despite the negative outcome of this study, we remain committed to applying rigorous science to unmet needs for patients with cancer,” added Antoine Yver,  global head of oncology R&D at Daiichi Sankyo.

Despite the drug’s disappointing results, it did post positive results in a phase 2 trial investigating its use in metastatic prostate cancer in 2014, succeeding in meeting its primary endpoint of progression-free survival compared to a placebo.

Unfortunately, an overwhelmingly negative portfolio for Tivantinib has done little for both ArQule and Daiichi. Yesterday, ArQule’s shares were down 4% prior to the news, whilst Daiichi’s dropped 0.5% upon release of the new data.

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