The STELLAR trial found that the addition of eflornithine to lomustine significantly improved overall and progression-free survival in patients with IDH-mut grade 3 astrocytoma but not in those with grade 4 disease. Eflornithine showed a cytostatic mechanism, doubling median PFS and improving OS in a subset of patients, though no new safety signals were observed.
Study
|
Phase III, randomized, open-label study [STELLAR] |
| Anaplastic astrocytoma progressed after temozolomide and radiotherapy |
| Eflornithine+Lomustine (n=172) vs Lomustine monotherapy (n=171)
|
Efficacy
|
ORR: 12.0% vs 8.8% |
| Median OS: 23.4 mos vs 20.3 mos (HR 0.94) |
| Median OS (IDH-mut grade 3): 34.9 mos vs 23.5 mos (HR 0.64) |
| Median PFS (IDH-mut grade 3): 15.8 mos vs 7.2 mos (HR 0.57)
|
Safety
|
Grade >=3 AEs: myelosuppression (42% vs 29%), hearing impairment (24% vs 0%) |
| Serious AEs: seizures (4% vs <1%), pulmonary embolism (4% vs 0%)
|
J Clin Oncol 2025;44:641-652
http://doi.org/10.1200/JCO-25-01204
Reviewed by Ulas D. Bayraktar, MD on Mar 12, 2026
