UPDATED RESULTS OF PHASE 3 STELLAR TRIAL: EFLORNITHINE IMPROVES OVERALL SURVIVAL AND BLINDED INDEPENDENT CENTRAL REVIEW DETERMINED PROGRESSION FREE SURVIVAL IN PATIENTS WITH RECURRENT WHO 2021 GRADE 3 IDH-MUTANT ASTROCYTOMA
Recommended Citation
Colman H, Lombardi G, Wong E, Walbert T, Eoli M, Lassman A, Peereboom D, Kizilbash S, Kamiya-Matsuoka C, Pitz M, Strowd R, Desjardins A, Kumthekar P, Mason W, Pellerino A, Soffietti R, Butowski N, Forsyth P, Hamza M, Hau P, Lallana E, Nabors B, Piccioni D, Uhlmann E, Welsh L, Wen P, Dietrich J, Levin V. UPDATED RESULTS OF PHASE 3 STELLAR TRIAL: EFLORNITHINE IMPROVES OVERALL SURVIVAL AND BLINDED INDEPENDENT CENTRAL REVIEW DETERMINED PROGRESSION FREE SURVIVAL IN PATIENTS WITH RECURRENT WHO 2021 GRADE 3 IDH-MUTANT ASTROCYTOMA. Neuro Oncol 2025; 27(Supplement 5):v139-v140.
Document Type
Conference Proceeding
Publication Date
11-11-2025
Publication Title
Neuro Oncol
Keywords
Oncology, Neurosciences & Neurology
Abstract
BACKGROUND: STELLAR was a phase III randomized, open-label trial of eflornithine (ornithine decarboxylase inhibitor) with lomustine versus lomustine alone in patients with recurrent anaplastic astrocytoma (AA). We previously reported an overall survival (OS) and progression free survival (PFS) of the combination in the patients with grade 3 IDH-mutant astrocytoma. Here we report updated OS and PFS outcomes based on additional molecular classification and blinded independent central review (BICR). METHOD: Eligibility included: age ≥ 18 years, AA (2016 WHO criteria) with first recurrence ≥ 6 months after radiation, KPS ≥ 70, and no imaging findings consistent with grade 4 glioblastoma. Patients received eflornithine (2.8 g/m2 TID Q 2/3 weeks) with lomustine (90 mg/m2 Q 6 weeks) (Arm A) or lomustine alone (110 mg/m2 Q 6 weeks) (Arm B). Primary endpoint was OS. RESULTS: Updated molecular data resulted in re-classification of the 343 AA patients enrolled into 3 WHO 2021 defined tumor subtypes, 196 tumors were IDHmut, CDKN2A/B intact, consistent with diagnosis of astrocytoma, IDHmut, WHO grade 3, 33 tumors had CDKN2A/B loss consistent with astrocytoma, IDHmut, WHO grade 4, 106 tumors were IDHwt consistent with diagnosis of glioblastoma, IDHwt, WHO grade 4. Updated results strengthen initial conclusion that eflornithine plus lomustine resulted in significant survival benefit in the astrocytoma, IDHmut, WHO grade 3 group (mOS 34.9 vs, 23.5 months, HR = 0.64, stratified log rank p =0.0136). PFS with eflornithine was also improved (15.8 vs, 7.2 months, HR = 0.57, stratified log rank p =0.0113). BICR demonstrated a high correlation between investigator and centrally determined PFS (p=0.0305), and high correlation between OS and PFS (p=.0001). CONCLUSION: The clinically meaningful OS and PFS benefits observed with eflornithine in the molecularly defined 2021 WHO CNS grade 3 astrocytomas is further confirmed and expanded based on additional molecular classification and BICR of PFS.
Volume
27
Issue
Supplement 5
First Page
v139
Last Page
v140
