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Agios Presents Updated Data from the Phase 1 Dose-escalation Study of Vorasidenib in Patients with IDH-mutant Non-enhancing Glioma
– Vorasidenib Demonstrated Prolonged Disease Control and Encouraging Preliminary Activity with Median Progression-free Survival of 31.4 Months – – Vorasidenib
About this update from Agios Pharmaceuticals, Inc.
[{"type":"text","content":"– Vorasidenib Demonstrated Prolonged Disease Control and Encouraging Preliminary Activity with Median Progression-free Survival of 31.4 Months –\n – Vorasidenib Demonstrated a Favorable Safety Profile at Doses Below 100mg Consistent with Previously Reported Data – – Registration-enabling Phase 3 INDIGO Trial of Vorasidenib Enrolling Patients with IDH-mutant Grade 2 Residual or Recurrent Non-enhancing Glioma – CAMBRIDGE, Mass., May 29, 2020 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today reported updated data from the ongoing Phase 1 study evaluating single agent vorasidenib in isocitrate dehydrogenase (IDH)-mutant advanced solid tumors, including glioma. Data from the non-enhancing glioma population were featured in an oral presentation at the 2020 American Society of Clinical Oncology (ASCO) annual meeting, which is being held virtually. Vorasidenib, an investigational, oral, selective, brain-penetrant inhibitor of mutant IDH1 and IDH2 enzymes, is currently being evaluated in the registration-enabling Phase 3 INDIGO study as a potential treatment for patients with residual or recurrent Grade 2 non-enhancing glioma. “For patients with IDH-mutant non-enhancing glioma who currently have limited treatment options beyond chemotherapy and radiation, targeted oral options such as vorasidenib are urgently needed,” said Ingo Mellinghoff, M.D., Memorial Sloan Kettering Cancer Center, an investigator for the Phase 1 dose-escalation study. “The updated results of this study in non-enhancing glioma patients provide further evidence of the potential benefit of vorasidenib for these patients, with a favorable safety profile and encouraging preliminary activity, including prolonged disease control, objective tumor responses, and clinically meaningful progression-free survival rates.” “These promising efficacy and safety data in patients with IDH-mutant non-enhancing glioma provide further support for our registration-enabling Phase 3 INDIGO study,” said Chris Bowden, M.D., chief medical officer at Agios. “With vorasidenib – the first and only brain-penetrant IDH inhibitor in Phase 3 trials for low-grade glioma – we have an opportunity to target a highly prevalent driver mutation early in the disease evolution, providing a therapeutic a...