DANA-FARBER CANCER INSTITUTE

GCAR and AstraZeneca will evaluate AZD1390 in GBM AGILE trial for newly diagnosed glioblastoma, with recruitment starting Q2 2025. GBM AGILE, the first global adaptive platform trial for glioblastoma, aims to identify effective therapies through adaptive randomization. AZD1390, an ATM kinase inhibitor, showed preliminary efficacy and manageable safety profile in Phase I data.

GCAR to evaluate AstraZeneca's AZD1390 in GBM AGILE trial for glioblastoma, aiming to expedite effective therapy identification. Recruitment for newly diagnosed patients starts Q2 next year. Data may support BLA and NDA submissions to the FDA.

AstraZeneca’s AZD1390 joins GBM AGILE, a Phase 2/3 adaptive platform trial for glioblastoma, targeting newly diagnosed patients; recruitment starts Q2 2025. GBM AGILE aims to rapidly identify effective therapies through adaptive randomization and a seamless phase 2/3 design, potentially enabling new drug applications. AZD1390, an ATM kinase inhibitor, shows promise in preclinical and Phase I trials as a radiosensitizer.

Ascentage Pharma appointed Ms. Marina S. Bozilenko and Dr. Debra Yu as independent non-executive directors, effective November 25, 2024.

Alpheus Medical announced positive Phase 1/2 trial results for sonodynamic therapy (SDT) in treating recurrent high-grade gliomas, showing extended median overall survival (OS) and progression-free survival (PFS) with a strong safety profile. The therapy combines low-intensity diffuse ultrasound (LIDU™) with oral 5-aminolevulinic acid (5-ALA) and is non-invasive, delivered in an outpatient setting.

Recent studies in The ASCO Post highlight: 1) Trastuzumab duocarmazine (T-Duo) improves progression-free survival in HER2-positive metastatic breast cancer. 2) Nivolumab plus ipilimumab shows activity in anaplastic thyroid carcinoma but not in non–biomarker-selected differentiated thyroid carcinoma. 3) Brexucabtagene autoleucel achieves high MRD-negative remission rates in relapsed/refractory B-cell ALL, with benefits from HCT consolidation. 4) Addition of bevacizumab to atezolizumab plus chemotherapy in advanced biliary tract cancer shows no overall survival benefit but suggests a role for high VEGFA expression as a predictive biomarker.

GCAR to evaluate AstraZeneca's AZD1390, an ATM kinase inhibitor, in GBM AGILE trial for newly diagnosed glioblastoma, with recruitment starting in early 2025. AZD1390, a brain-penetrant compound, has shown activity in combination with radiation and a manageable safety profile in a phase I trial.