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ESMO 2025 | Evaluating olaparib, radiotherapy and temozolomide in unresectable gliomas

Dinu Stefan, MD, François Baclese Cancer Center, Caen, France, discusses the Phase IIa OLA-TMZ-RTE-01 trial (NCT03212742) of intermittent olaparib combined with radiotherapy and temozolomide in patients with unresectable high-grade gliomas. The study explored safety, tolerability, and preliminary efficacy as a first-line treatment following surgery. Interim results suggest encouraging overall survival compared with historical outcomes for standard radiochemotherapy, with manageable hematologic toxicities. This interview took place at the European Society for Medical Oncology (ESMO) 2025 Congress in Berlin, Germany.

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Transcript

Indeed, this year at ESMO, we present the preliminary results of phase 2 of the OLA TMZ RTE-01 trial, investigating the association between olaparib, irradiation, and temozolomide in first-line treatment of unresectable high-grade glioma. This is an academic study funded by the French National Cancer Institute and supported by AstraZeneca. The first outcomes of FAS1 were presented at a meeting in 2023 and published this year...

Indeed, this year at ESMO, we present the preliminary results of phase 2 of the OLA TMZ RTE-01 trial, investigating the association between olaparib, irradiation, and temozolomide in first-line treatment of unresectable high-grade glioma. This is an academic study funded by the French National Cancer Institute and supported by AstraZeneca. The first outcomes of FAS1 were presented at a meeting in 2023 and published this year. Now we present the results of phase two. Indeed, we included in this study 68 patients with unresectable high-grade glioma and 40% of patients had only a biopsy. At the follow-up of 12.5 months, we observed a median overall survival of 17.2 months, which is quite encouraging. So even if we included in this study only patients with a poor prognosis, we observed an improvement in survival in these patients while the tolerance remains acceptable. So this strategy seems to be promising and I think it is worth being compared to the standard of treatment in phase three controlled trials. The presentation tomorrow will be an opportunity to speak with my colleagues at the European level in order to decide the best design and feasibility of such a study.

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