Safety and Efficacy Study of Safusidenib in Participants With IDH1-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive Disease

ORR per modified RANO 2.0 assessed by Investigator

ORR defined as the proportion of participants with the confirmed best overall response of CR, PR or MR per modified RANO 2.0, assessed by the Investigator

Time frame: From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months

Volumetric Tumor Growth Rate (TGR) by BICR

TGR defined as the percentage change in tumor volume by unit of time, assessed by BICR

Time frame: From historical scans through the final scan in the study, approximately 18 months

Duration of Response (DOR) per modified RANO 2.0 assessed by BICR and by Investigator

DOR, time from the first documentation of objective response (CR, PR, or MR) to the date of the first occurrence of radiographic disease progression per modified RANO 2.0 assessed by BICR and by the Investigator or death from any cause, whichever occurs earlier.

Time frame: From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months

Time to Next Intervention (TTNI)

TTNI, defined as the time from the first dose of study drug to the initiation of first subsequent anticancer therapy or death from any cause, whichever occurs earlier

Time frame: From the date of first dose of study drug until the date of the start of another anticancer treatment or date of death, approximately 18 months

Progression Free Survival (PFS) per modified RANO 2.0 assessed by BICR and by Investigator

PFS, defined as the time from the first dose of study drug to the date of the first occurrence of radiographic disease progression per modified RANO 2.0 assessed by BICR and by the Investigator or death from any cause, whichever occurs earlier.

Time frame: From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months

Time to Response (TTR) per modified RANO 2.0 assessed by BICR and by Investigator

TTR, defined as the time from the first dose of study drug to the first documentation of objective response (CR, PR, or MR) per modified RANO 2.0, assessed by BICR and by the Investigator

Time frame: From the date of first dose of study drug to the first documentation of objective response (CR, PR, or MR), approximately 18 months

Overall Survival (OS)

OS, defined as the time from the first dose of study drug to death from any cause.

Time frame: From the date of first dose of study drug until the date of death, approximately 18 months

Safety and tolerability

The safety and tolerability of safusidenib evaluated based on AEs graded by NCI-CTCAE version 5.0, laboratory abnormalities as graded by NCI-CTCAE version 5.0, vital signs, physical examinations, and ECGs

Time frame: From the date of first dose of study drug until 30 days after the date of the last dose of study drug, approximately 18 months

Seizure Activity

Evaluate seizure frequencies and severity including type of seizure, seizure-related AEs, and changes in anti-epileptic medications in participants receiving safusidenib

Time frame: From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months