About the results of eflornithine tablets in the treatment of grade 3 anaplastic astrocytoma

ABOUT STELLAR Results from a phase 3 trial (NCT02796261) investigating the use of eflornithine tablets in patients with recurrentIDH-mutant grade 3 anaplastic astrocytoma > (eflornithine) plus lomustine(Lomustine) when treated alone with lomustine.

The intention-to-treat (ITT) population of the STELLAR study enrolled patients in 3 different subpopulations: IDH-mutant, CDKN2-intact tumors; IDH-mutant tumors with CDKN2 deletion; and IDH wild-type tumors. Of note, the World Health Organization's definition of anaplastic astrocytoma evolved as the study progressed, leading trial investigators to evaluate findings in the ITT population and in patients who met the World Health Organization's 2021 molecular definition of anaplastic astrocytoma diagnostic criteria.

The final analysis of the ITT population showed modest improvements in progression-free survival (PFS) and overall survival (OS) in patients treated with eflornithine (n=172) compared with lomustine alone (n=171); however, these findings were not statistically significant, Coleman said. Median OS was 23.4 months in the eflornithine group compared with 20.3 months in the control group (HR, 0.94).

Notably, data from prespecified subgroup analyzes showed statistically significant and clinically meaningful benefits on PFS and OS with eflornithine versus lomustine alone in the 2021 World Health Organization-defined subgroup of patients with IDH mutations in grade 3 astrocytoma (n=194). In this population, the median OS with eflornithine was 34.9 months, compared with 23.5 months with lomustine alone (HR, 0.64; log-rank P = 0.016). Median PFS for these groups was 15.8 months and 7.2 months, respectively (HR, 0.58; log-rank P = 0.015).

Reference materials:https://www.drugs.com/mtm/eflornithine.html