DDDR-36. VAL-083 IN PATIENTS WITH RECURRENT GLIOBLASTOMA TREATED UNDER EXPANDED ACCESS PROGRAM

Abstract Current standard-of-care for glioblastoma (GBM) includes surgery followed by radiation with concurrent and adjuvant temozolomide. There are limited treatment options available upon progression or recurrence of disease. Options often involve participation in clinical trials promising new therapies. However, patients may not meet the strictly defined entry criteria to participate these trials. Under an Expanded Access (EA) program, we have treated 14 recurrent GBM VAL-083, they were eligible other The median time from last start VAL-083 was 1.0 month (95%CI:0.09-2.67). All had received chemoradiation Five (5/14;36%) ≥ 2 recurrences, 8/14 (57%) multifocal disease, KPS 80 (95%CI:70-90). unmethylated MGMT promoter, 13/14 (93%) IDH-WT, 9/14 (64%) a TERT promoter mutation, 6/14 (43%) PTEN 4/14 (28%) EGFR mutation. at 30 mg/m2 x 3 days every 21 days. cerebral edema refractory steroids bevacizumab (BEV;10 mg/kg) concurrently 8 dexamethasone (Dex; >4 mg/day) VAL-083. This is first report use combination BEV (VAL-03/BEV).The main adverse event thrombocytopenia consistent prior experience. Four (4/14; 28%) dose reduction, which due thrombocytopenia. No reduction while receiving VAL-083/BEV. Two who progressed on later CCNU, myelosuppression observed.Median progression-free survival (mPFS) overall (mOS) 5.7 months (95%CI:1.3-7.9) 8.3 (95%CI:3.0-14.3), respectively. Additional treatment, safety outcome data will be presented meeting.Clinicaltrials.gov Identifier: NCT03138629. EA plans approved MD Anderson Cancer Center IRB.