The first Australian participant has now been enrolled in VIGOR, the international phase III trial evaluating vorasidenib in IDH-mutant astrocytoma.
COGNO is pleased to announce the enrolment of the first Australian participant in VIGOR (Vorasidenib Maintenance for IDH-mutant Astrocytoma; EORTC-2427-BTG; NCT06809322), an international phase III trial investigating maintenance vorasidenib. This is a significant milestone for the trial in Australia.
The trial is testing whether vorasidenib, an oral brain-penetrant inhibitor of mutant IDH1/2 enzymes, can delay disease progression compared with placebo in adults with newly diagnosed IDH-mutant WHO grade 2 or 3 astrocytoma who have completed surgery and first-line chemoradiotherapy. It will also assess overall survival, time to the next intervention, safety, quality of life, and neurological and cognitive outcomes.
Why VIGOR matters
VIGOR builds on promising results from the INDIGO trial which showed that vorasidenib delayed disease progression in people with IDH-mutant gliomas who had received surgery alone.
The recent PBS listing of vorasidenib is an important advance for eligible Australians with IDH-mutant grade 2 glioma who have undergone surgery and do not require immediate radiotherapy or chemotherapy.
However, an important evidence gap remains for people who have higher-risk disease requiring upfront chemoradiotherapy, including those with grade 2 or grade 3 astrocytoma.
VIGOR will address this evidence gap by testing the effect of vorasidenib after post-operative chemoradiotherapy, to help inform future treatment for people with grade 2 or 3 astrocytoma.
Australian contribution to the international trial
VIGOR is globally sponsored and coordinated by the European Organisation for Research and Treatment of Cancer (EORTC).
In Australia, COGNO is delivering the trial in partnership with the Olivia Newton-John Cancer Research Institute (ONJCRI), with Professor Eng-Siew Koh as the Australian Coordinating Investigator.
This international study aims to enrol 468 participants across 12 countries. Australia plans to enrol 70 participants across 10 COGNO sites.
We thank the participants and their families, investigators, and the trial teams whose contributions make this research possible.
Refer a patient to VIGOR
Australian sites are opening progressively. If you are a clinician caring for a potentially eligible patient, please contact the VIGOR team to discuss eligibility, site availability and referral pathways.
