This week, ArQule, a biotechnology company focused on developing "next-generation" small-molecule cancer drugs, announced that a drug trial for a lung cancer treatment it developed has been stopped early.
The independent Data Monitoring Committee (DMC) overseeing the Phase 3 trial recommended that the study be halted following an interim analysis that concluded the trial would not show improved overall survival for patients.
The study looked at around 1,000 patients from over 200 sites worldwide. It was a randomized, double-blind, controlled trial that investigated the drug tivantinib in conjunction with erlotinib. Tivantinib was co-developed by ArQule and the Japanese pharmaceutical company Daiichi Sankyo. The patients were all previously treated, and had locally advanced or metastatic, non-squamous, non-small cell lung cancer.
Though the interim analysis found improvement in patients' progression-free survival in the "intent-to-treat" population, similar results did not show up for overall survival. The interim analysis also found no safety concerns with regards to the treatment.
"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, CEO of ArQule.
Daiichi Sankyo's global head of R&D stated that the companies will "continue to investigate tivantinib in other tumor types."
The cancelled trial has been seen as a huge blow by ArQule investors, and the Wall Street Journal reports that the company's stock dropped 55% in light of the news, down to $2.15 at the close of Tuesday's trading.