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Johnson, Theodore S; Pacholczyk, Rafal; Aguilera, Dolly; Berrong, Zuzana; Castellino, Robert C; Chi, Susan; Creager, Julianne; Eaton, Bree R; Fangusaro, Jason R; Huang, Chenbin; Hummel, Trent; Ingerski, Lisa; Kennedy, Eugene P; Ring, Eric; Sadek, Ramses F; Satpathy, Sarthak; Schniederjan, Matthew; Thomas, Beena E; Yeo, Kee Kiat; Bhasin, Manoj; MacDonald, Tobey J; Munn, David H

HGG-28. INTERIM ANALYSIS OF THE GCC1949 PHASE 2 TRIAL USING INDOXIMOD-BASED CHEMO-IMMUNOTHERAPY FOR PATIENTS WITH PEDIATRIC BRAIN TUMORS

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  • Medientyp: E-Artikel
  • Titel: HGG-28. INTERIM ANALYSIS OF THE GCC1949 PHASE 2 TRIAL USING INDOXIMOD-BASED CHEMO-IMMUNOTHERAPY FOR PATIENTS WITH PEDIATRIC BRAIN TUMORS
  • Beteiligte: Johnson, Theodore S; Pacholczyk, Rafal; Aguilera, Dolly; Berrong, Zuzana; Castellino, Robert C; Chi, Susan; Creager, Julianne; Eaton, Bree R; Fangusaro, Jason R; Huang, Chenbin; Hummel, Trent; Ingerski, Lisa; Kennedy, Eugene P; Ring, Eric; Sadek, Ramses F; Satpathy, Sarthak; Schniederjan, Matthew; Thomas, Beena E; Yeo, Kee Kiat; Bhasin, Manoj; MacDonald, Tobey J; Munn, David H
  • Erschienen: Oxford University Press (OUP), 2023
  • Erschienen in: Neuro-Oncology, 25 (2023) Supplement_1, Seite i46-i46
  • Sprache: Englisch
  • DOI: 10.1093/neuonc/noad073.177
  • ISSN: 1523-5866; 1522-8517
  • Schlagwörter: Cancer Research ; Neurology (clinical) ; Oncology
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: Abstract Brain tumors are the leading cause of cancer-related death in children. We report interim results of an ongoing multi-institutional phase 2 trial (NCT04049669) of the IDO pathway-inhibitor indoximod utilized in a chemo-immunotherapy regimen for patients 3-21 years of age with either recurrent malignant brain cancer or newly-diagnosed diffuse intrinsic pontine glioma (DIPG). Patients are treated with oral indoximod (38.4 mg/kg/day, divided BID) plus oral temozolomide (200 mg/m2/day for 5 days) in 28-day cycles. Patients for whom radiation therapy is planned as standard-of-care receive indoximod during the up-front radiation regimen. During treatment, palliative radiation, surgery, or dexamethasone are allowed as needed for clinical management. To date, 53 patients have been treated. Estimated median follow-up time was 23 months (range 0.2-35.5 months), and indoximod-based therapy was well tolerated. Estimated median overall survival (OS) was 15 months for the entire mixed population (n= 53, 95%-C.I. 11.5-23.2 months); 23.8 months for recurrent ependymoma (n=26); 13.5 months for recurrent medulloblastoma (n=12); 5.8 months for recurrent glioblastoma/diffuse midline glioma (GBM/DMG, n=9, excludes DIPG); and 9.6 months for newly-diagnosed DIPG (n=6). For the 39 response-evaluable patients to date (those with measurable disease and at least one follow-up MRI on-therapy), objective response in any single lesion by pediatric RANO criteria occurred in 20/39 patients (9/17 ependymoma, 9/11 medulloblastoma, 0/6 GBM/DMG, 2/5 DIPG). Lesion response was associated with significantly better overall survival (estimated median OS 23.2 months, n=20) compared to patients without lesion response (median OS 6.6 months, n=19) (p=0.0005). Single-cell RNA sequencing of serial peripheral blood samples allowed identification of expanded T cell clones, which was correlated with survival. Updated results from the first 53 patients will be presented. These data are replicating results of the preceding phase 1 study (NCT02502708) and provide preliminary evidence of anti-tumor activity in pediatric brain tumors.
  • Zugangsstatus: Freier Zugang