REVOLUMAB: A phase II trial of Nivolumab in recurrent IDH mutant high-grade gliomas - Institut Pierre Louis d'Epidémiologie et de Santé Publique Accéder directement au contenu
Article Dans Une Revue European Journal of Cancer Année : 2024

REVOLUMAB: A phase II trial of Nivolumab in recurrent IDH mutant high-grade gliomas

Résumé

Background: Novel effective treatments are needed for recurrent IDH mutant high-grade gliomas (IDHm HGGs). The aim of the multicentric, single-arm, phase II REVOLUMAB trial (NCT03925246) was to assess the efficacy and safety of the anti-PD1 Nivolumab in patients with recurrent IDHm HGGs. Patients and methods: Adult patients with IDHm WHO grade 3-4 gliomas recurring after radiotherapy and ≥ 1 line of alkylating chemotherapy were treated with intravenous Nivolumab until end of treatment (12 months), progression, unacceptable toxicity, or death. The primary endpoint was the 24-week progression-free survival rate (24w-PFS) according to RANO criteria. Results: From July 2019 to June 2020, 39 patients with recurrent IDHm HGGs (twenty-one grade 3, thirteen grade 4, five grade 2 with radiological evidence of anaplastic transformation; 39% 1p/19q codeleted) were enrolled. Median time since diagnosis was 5.7 years, and the median number of previous systemic treatments was two. The 24w-PFS was 28.2% (11/39, CI95% 15-44.9%). Median PFS and OS were 1.84 (CI95% 1.81-5.89) and 14.7 months (CI95% 9.18-NR), respectively. Four patients (10.3%) achieved partial response according to RANO criteria. There were no significant differences in clinical or histomolecular features between responders and non-responders. The safety profile of Nivolumab was consistent with prior studies. Conclusions: We report the results of the first trial of immune checkpoint inhibitors in IDHm gliomas. Nivolumab failed to achieve its primary endpoint. However, treatment was well tolerated, and long-lasting responses were observed in a subset of patients, supporting further evaluation in combination with other agents (e.g. IDH inhibitors).
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hal-04625395 , version 1 (26-06-2024)

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Picca Alberto, Touat Mehdi, Belin Lisa, Gourmelon Carole, Harlay Vincent, et al.. REVOLUMAB: A phase II trial of Nivolumab in recurrent IDH mutant high-grade gliomas. European Journal of Cancer, 2024, 202, pp.114034. ⟨10.1016/j.ejca.2024.114034⟩. ⟨hal-04625395⟩
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