November 25, 2024

Perioperative Vorasidenib and Ivosidenib Remain Effective, Safe in IDH1+ Diffuse Glioma

Ashling Wahner

Fact checked by:Chris Ryan

Conference|Society for Neuro-Oncology Annual Meeting

Perioperative vorasidenib or ivosidenib demonstrated sustained clinical benefit in patients with predominantly non-enhancing IDH1-mutant diffuse

Vorasidenib (Voranigo) or ivosidenib (Tibsovo) administered before and after surgery demonstrated sustained clinical benefit in patients with predominantly non-enhancing IDH1-mutant diffuse glioma, according to updated findings from a phase 1 trial (NCT03343197) presented at the 2024 Society for Neuro-Oncology (SNO) Annual Meeting.

At a data cutoff date of September 23, 2023, 64% of evaluable patients who received vorasidenib (n = 22) and 45.4% of evaluable patients who received ivosidenib experienced tumor reduction. The overall response rate (ORR) among evaluable patients who received vorasidenib (n = 22) was 45.5%, including partial response (PR), minor response (MR), stable disease (SD), and progressive disease (PD) rates of 18.2%, 27.3%, 36.4%, and 18.2%, respectively. The median time to response in this arm was 9.2 months (range, 2-20), and the median duration of response (DOR) was not evaluable (NE; range, 14.7 months-NE). The median duration of treatment was 44.67 months .(range, 0.9-62.7)

The ORR among evaluable patients who received ivosidenib (n = 22) was 31.8%, including PR, MR, SD, and PD rates of 22.7%, 9.1%, 59.1%, and 9.1%, respectively. The median time to response in this arm was 5.6 months (range, 2-13), and the median DOR was 42.4 months (range, 1.8-NE). The median duration of treatment was 23.92 months (range, 0.0-62.7).

“With additional [follow-up of approximately] 3.5 years from previously published results, vorasidenib and ivosidenib continue to show clinical benefit immediately after surgery in patients with predominantly non-enhancing glioma,” presenting author Timothy F. Cloughesy, MD, and coauthors wrote in a presentation of the data. “Vorasidenib resulted in durable disease control including objective responses, consistent with phase 3 INDIGO study [NCT04164901] results.”

Cloughesy is a professor and director in the Department of Neurology, Neurological Services, and the Neuro-Oncology Program, as well as a physician in the Department of Neurology and a member of the Brain Research Institute at the UCLA Health Jonsson Comprehensive Cancer Center in Los Angeles, California