2025/12/08
Polaris Group (TWSE:6550) is pleased to report the encouraging Phase 1 clinical trial results of its lead drug pegargiminase (ADI-PEG 20) in patients with acute myeloid leukemia (AML) that were presented at the annual meeting of the American Society of Hematology.
Pegargiminase was combined with standard of care venetoclax and azacitidine chemotherapy in newly diagnosed patients who were older or unfit for intensive chemotherapy. Of the 25 patients enrolled, 16 (64%) had high risk mutations, and 9 others (36%) had secondary type mutations. Of the 23 patients evaluable, 16 (69.6%) had a complete response, and the total composite objective response rate was 21/23 (91.3%) with durable responses. Median overall survival was 19.1 months, and 14/23 (60.9%) were censored for overall survival (still alive). These results compare favorably with results for the chemotherapy alone. The safety profile was consistent with the expected profile of the chemotherapy. Pegargiminase was well tolerated with no dose limiting toxicity.
Steve Hsu, Chairman of Polaris Group, stated: “The high rate of responses durability of these responses, and overall survival was better than expected in this very-high risk AML population. We are encouraged by these results and are considering next steps.”