CTNI-58. 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

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.

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Journal
Neuro-Oncology
Published
2025-11-01
DOI
https://doi.org/10.1093/neuonc/noaf201.0554
Primary Topic
Glioma Diagnosis and Treatment
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article
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article

CTNI-58. 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

Annick Desjardins, Carlos Kamiya-Matsuoka, Patrick Yung Wen, Roy E. Strowd et al.
Neuro-Oncology
Glioma Diagnosis and Treatment
article

CTNI-58. 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

Annick Desjardins, Carlos Kamiya-Matsuoka, Patrick Yung Wen, Roy E. Strowd, Tobias Walbert, Sani H. Kizilbash, Marshall Pitz, Peter Hau, Peter Forsyth, Howard Colman, Eric T. Wong, Jörg Dietrich, Liam Welsh, Erik J. Uhlmann, Andrew B. Lassman, Marica Eoli, Giuseppe Lombardi, David Piccioni, David M. Peereboom, Burt Nabors, Alessia Pellerino, Enrico C. Lallana, Riccardo Soffietti, Nicholas Butowski, Priya Kumthekar, Warren Mason, Mohamed A. Hamza, Victor A. Levin
article en

Abstract

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.

Neuro-OncologyVol. 27(Supplement_5)
Northwestern University (US), OhioHealth (US), Beth Israel Deaconess Medical Center (US), Cleveland Clinic (US), Mayo Clinic (US), The University of Texas MD Anderson Cancer Center (US), University of California, San Francisco (US), University of Utah (US), Columbia University Irving Medical Center (US), Hadassah Medical Center (IL), Huntsman Cancer Institute (US), Ohio Department of Health (US), Toronto General Hospital (CA), Henry Ford Hospital (US), Moffitt Cancer Center (US), University Hospital Regensburg (DE), University of Alabama at Birmingham (US), University of California San Diego (US), Massachusetts General Hospital (US), Northwestern University (PH), Istituto Oncologico Veneto (IT), Dana-Farber Cancer Institute (US), Royal Marsden Hospital (GB), Kaiser Permanente Sacramento Medical Center (US), Duke Medical Center (US), Orbus Therapeutics (United States) (US), Mayo Clinic in Florida (US), Lifespan (US), Fondazione IRCCS Istituto Neurologico Carlo Besta (IT), University of Manitoba (CA), Wake Forest University (US), University of Turin (IT)
Openalex Percentile: Top 52%
Glioma Diagnosis and Treatment
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