Met inhibitor ARQ 197 plus Erlotinib vs Erlotinib plus placebo in NSCLC or MARQUEE, which had successfully entered its Phase 3 trial, has been put to an end by ArQule Inc. and Daiichi Sankyo Co., a report has unveiled recently.
The termination, as per the findings, is being seen after an announcement by the Data Monitoring Committee, an independent body. The group had carried out a provisional review into the trial process and has been claiming that the study would eventually fail to improve survival rates.
The drug had been developed with an aim to fight the deadly lung cancer. The agreement to develop the drug tivantinib for Europe, South America and the US had been signed by the two companies in the month of December 2008. Some countries excluded were Japan, China, Taiwan and South Korea.
Though, the investigating group has discovered no safety concerns in relation to the drug. It is being said that the shares of ArQule would slip by almost 60% if the trial proceeds.
"We are disappointed that the MARQUEE trial did not provide statistically significant results for overall survival in a disease and treatment setting which remains a major unmet medical need”, said Paolo Pucci, ArQule chief executive officer.
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