Results from the pivotal phase III INDIGO trial show that vorasidenib was associated with a significant delay in time to disease progression when compared with placebo
The investigational drug vorasidenib from Servier is awaiting approval for use in gliomas bearing mutations in isocitrate dehydrogenase 1 and 2 (IDH1, IDH2).
Results from the pivotal phase III INDIGO trial show that the drug was associated with a significant delay in time to disease progression when compared with placebo. The median progression-free survival (PFS) was 27.7 months for patients on vorasidenib, compared with 11.1 months for patients assigned to placebo (hazard ratio (HR) for progression or death with vorasidenib of 0.39 (P < .0001).
Vorasidenib was also associated with significantly longer time to the next treatment, and patients generally tolerated the drug well, reported first author Ingo K. Mellinghoff, MD, from Memorial Sloan Kettering Cancer Center, New York City.
The results show that treatment with an oral precision medicine therapy can produce a reduction in the risk of tumor progression by 61%, so that is a significant sign of efficacy that has potential to change the landscape in this disease. The study was published online in The New England Journal of Medicine to coincide with the presentation.
See- Vorasidenib in IDH1- or IDH2-Mutant Low-Grade Glioma"- Ingo K. Mellinghoff, M.D., Martin J. van den Bent, M.D., Deborah T. Blumenthal, M.D., Mehdi Touat, M.D., et al. June 4, 2023 DOI: 10.1056/NEJMoa2304194.
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