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Olutasidenib in recurrent/relapsed locally advanced or metastatic IDH1-mutated chondrosarcoma: phase 1b/2 trial
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Olutasidenib in recurrent/relapsed locally advanced or metastatic IDH1-mutated chondrosarcoma: phase 1b/2 trial
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Olutasidenib in recurrent/relapsed locally advanced or metastatic IDH1-mutated chondrosarcoma: phase 1b/2 trial
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Journal Article
Olutasidenib in recurrent/relapsed locally advanced or metastatic IDH1-mutated chondrosarcoma: phase 1b/2 trial
2026
Overview
Chondrosarcomas are rare cartilaginous neoplasms with limited treatment options. Isocitrate dehydrogenase 1/2 (m
IDH1/2
) mutations occur in 65% of chondrosarcomas. Here we report safety and efficacy of olutasidenib, an mIDH1 inhibitor, evaluated in patients with locally advanced or metastatic m
IDH1
chondrosarcoma (Clinicaltrials.gov identifier: NCT03684811). The primary endpoint was objective response rate by tumor evaluation; secondary endpoints included adverse events, progression-free and overall survival. Patients received olutasidenib 150 mg twice daily. Twenty-three patients were enrolled; 16 were diagnosed with conventional chondrosarcoma (cCS). Median age was 57 (range, 30-71) years. In 21 response-evaluable patients, 11 (52%) had stable disease, 8 (38%) had progressive disease, and 2 (10%) were not evaluable. Median progression-free survival (mPFS) was 2.0 months (95% confidence interval [95%CI]: 1.7, 4.7); median overall survival was 16.0 months (95%CI: 7.7, not reached). Among patients with cCS, 10 (63%) had stable disease; 6 (38%) had progressive disease; mPFS was 3.5 months (95%CI: 1.7, 5.1). Median overall survival in cCS patients was 19.0 months (95% CI: 7.7, not reached). No dose-limiting toxicities were reported during the study. Olutasidenib was well tolerated and conferred disease control in cCS. Study limitations include open-label design and low patient sample due to rarity of cCS.
Chondrosarcomas are rare cartilaginous neoplasms with limited treatment options. Here this trial evaluates the safety and efficacy of olutasidenib (mIDH1 inhibitor) on 23 patients with locally advanced or metastatic mIDH1 chondrosarcoma.
Publisher
Nature Publishing Group UK,Nature Publishing Group
Subject
/ Adult
/ Aged
/ Antineoplastic Agents - adverse effects
/ Antineoplastic Agents - therapeutic use
/ Bone Neoplasms - drug therapy
/ Chondrosarcoma - drug therapy
/ Female
/ Humanities and Social Sciences
/ Humans
/ Isocitrate Dehydrogenase - genetics
/ Male
/ Mutation
/ Neoplasm Recurrence, Local - drug therapy
/ Neoplasm Recurrence, Local - genetics
/ Patients
/ Pyridines - administration & dosage
/ Pyrimidines - adverse effects
/ Pyrimidines - therapeutic use
/ Science
/ Survival
