Polaris Group announced today that positive results from a randomized Phase 2 trial of ADI-PEG 20, arginine deiminase formulated with polyethylene glycol, for the treatment of malignant pleural mesothelioma were presented at the World Conference on Lung Cancer in Sydney, Australia. There were 68 subjects randomized, 44 to ADI-PEG 20 plus best supportive care and 24 to best supportive care only. The target endpoint, enhanced progression free survival in those treated with ADI-PEG 20, was met with a hazard ratio of 0.53. In addition, partial responses, as determined by PET scanning, were observed in 46% of subjects treated with ADI-PEG 20. The drug was also well tolerated. The study was led by Dr. Peter Szlosarek of Barts Cancer Center, Queen Mary University of London, and involved multiple sites in the United Kingdom. Polaris Group is conducting clinical trials on ADI-PEG 20 for the treatment of several other indications, including hepatocellular carcinoma. The latter indication is already in a global Phase 3 study.
“We are pleased with the results of this randomized study of ADI-PEG 20. We plan to further investigate these results by performing a study of ADI-PEG 20 plus combination chemotherapy in mesothelioma,” said John Bomalaski, M.D., Executive Vice President of Medical Affairs at Polaris Group. “ADI-PEG 20 is currently being evaluated in combination with cisplatin in melanoma and in combination with docetaxel in prostate cancer and non-small cell lung carcinoma. ADI-PEG 20 has a unique mechanism of action that we believe can complement the mechanisms of action of other agents in multiple studies to date. We are excited for such new studies to begin.”