Is Vorasidenib Monotherapy Effective for Glioma?
Medical Supporter — Informationshinweis
Dieser Artikel ist eine Zusammenfassung internationaler medizinischer Informationen und stellt keine medizinische Beratung dar; er ersetzt nicht die Diagnose oder den Behandlungsplan Ihres behandelnden Arztes. Die dargestellten Informationen stammen aus öffentlichen Veröffentlichungen und offiziellen Angaben führender japanischer medizinischer Einrichtungen; Eignung und Wirkung einer Therapie sind individuell und müssen von einem qualifizierten Arzt beurteilt werden.
On August 17, 2023, Ingo K. Mellinghoff and colleagues from Memorial Sloan Kettering Cancer Center published the results of the INDIGO Phase III clinical trial in the medical journal "The New England Journal of Medicine." The trial investigated the effectiveness and safety of vorasidenib monotherapy in patients with IDH1/2-mutant recurrent grade 2 glioma.
In this Phase III clinical trial, patients with IDH1/2-mutant recurrent grade 2 glioma (N=331) were randomly assigned to either the vorasidenib group (40mg once daily in 28-day cycles, N=168) or the placebo group (N=163). The primary endpoint was progression-free survival (PFS), and a key secondary endpoint was the time to next treatment (the period before starting another anticancer drug as second-line treatment).
With a median follow-up of 14.2 months, the median progression-free survival was 27.7 months for the vorasidenib group and 11.1 months for the placebo group. The secondary endpoint, time to next treatment, showed significant improvement in the vorasidenib group compared to the placebo group.
The incidence of side effects of Grade 3 or higher was 22.8% in the vorasidenib group and 13.5% in the placebo group. Among Grade 3 or higher side effects, the incidence of elevated ALT (alanine aminotransferase) was 9.6% in the vorasidenib group and was not observed in the placebo group.
Based on the results of the INDIGO trial, Ingo K. Mellinghoff and colleagues stated that vorasidenib monotherapy significantly improved progression-free survival and delayed the time to next treatment in patients with IDH1/2-mutant recurrent grade 2 glioma.
-
Clinical Trial Drugs
(Lung Cancer) Phase II Clinical Trial Results of Topotecan and Topotecan + Berzosertib Treatment. (Lung Cancer) Is Enhertu Effective for HER2-Mutant Non-Small Cell Lung Cancer? (Lung Cancer) Is the Anti-B7-H3 Antibody Drug DS-7300 Effective?
Medical Supporter was formerly certified as an international medical visa guarantor by Japan's Ministry of Foreign Affairs and the Ministry of Economy, Trade and Industry (B-066).
Behandlung in Japan im Blick? Brauchen Sie Informationen und Unterstützung?
Wir helfen Ihnen, die für eine medizinische Reise nach Japan nötigen Informationen zu ordnen, kontaktieren japanische Einrichtungen und organisieren eine Zweitmeinungsberatung.Die Erstberatung ist kostenlos; ein Berater hilft Ihnen, die nächsten Schritte zu klären.
Figure 1
Figure 2
Figure 3
Figure 4