Trial Outcomes & Findings for BGB-290 and Temozolomide in Treating Patients With Recurrent Gliomas With IDH1/2 Mutations (NCT NCT03914742)

Enrollment started Feb 2020 \& the last patient enrolled 4/4/22. The trial terminated early due to mandated closed to accrual and treatment on October 31 2023. The final clinical data includes a total of 67 subjects enrolled and 66 evaluable. Due to mandated closure of treatment and follow-up on 10/31/23, many patients were moved to compassionate use and dealth dates post 10/31/23 could not be collected or confirmed. The termination of the trial is considered an administrative termination.

67 patients signed consent, however, 1 patient in the Phase 1 Dose Finding, never started treatment before they withdrew, hence 66 evaluable patients.

BGB-290 and Temozolomide in Treating Patients With Recurrent Gliomas With IDH1/2 Mutations

DLTS defined as the combination regimen that yields a dose limiting toxicity (DLT) rate less than, or equal to 33%. A DLT is defined as a clinically significant adverse event or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications and meets any of the criteria below. Any DLT must be a toxicity considered at least possibly related to pamiparib (BGB-290) or TMZ.

Patients treated with TMZ 20mg Days 1-28, highest dose level/schedule. If DTL observed, dose level/schedule will de-escalated treatment schedule if necessary (days 1-21; days 1-14; days 1-7) BGG held constant at 60mg PO BID

Number of participants with response as defined by Response Assessment in Neuro-oncology (RANO) criteria: Complete Response (CR)= no change in size of T1-gadolinium-enhancing (T1-Gd+) disease, stable or reduced T2/FLAIR signal, no new lesion, no corticosteroid use, and stable or improved clinical status; Partial Response (PR)= ≥50% change in size of T1-Gd+ disease, stable or reduced T2/FLAIR signal, no new lesion, stable or reduced corticosteroid use, and stable or improved clinical status; Stable Disease (SD)= \<50% reduction to \<25% increase size of T1-Gd+ disease, stable or reduced T2/FLAIR signal, no new lesion, stable or reduced corticosteroid use, and stable or improved clinical status; Progressive Disease (PD)= ≥25% increase size of T1-Gd+ disease, or increased T2/FLAIR signal, or presence of new lesion, or worsening clinical status.

Time from date of treatment start to date of initial scan indicating progression

Median time from start date of treatment to date of death

Time from date of initial scan indicating complete or partial response to a date of the initial scan deemed tumor progression. Response is defined by RANO criteria as follows: Complete Response (CR)= no change in size of T1-gadolinium-enhancing (T1-Gd+) disease, stable or reduced T2/FLAIR signal, no new lesion, no corticosteroid use, and stable or improved clinical status; Partial Response (PR)= ≥50% change in size of T1-Gd+ disease, stable or reduced T2/FLAIR signal, no new lesion, stable or reduced corticosteroid use, and stable or improved clinical status; Progressive Disease (PD)= ≥25% increase size of T1-Gd+ disease, or increased T2/FLAIR signal, or presence of new lesion, or worsening clinical status.