AACR24: AstraZeneca's glioblastoma drug shows potential in Phase I trial
10 Apr 2024
Clinical ResultAACRPhase 1
AstraZeneca's investigational ATM kinase inhibitor AZD1390ATM kinase inhibitor AZD1390, when given with standard-of-care radiotherapy, demonstrated a manageable safety profile and preliminary efficacy in patients with glioblastoma (GBM) in a Phase I trial.
Scientists presenting at the American Association for Cancer Research (AACR) annual meeting said AZD1390 demonstrated a manageable safety profile in patients with recurrent or newly diagnosed GBM when given in combination with Intensity-modulated radiation therapy (IMRT) and showed preliminary efficacy in patients with recurrent GBM.
"Glioblastoma is a lethal cancer with the majority of patients not surviving past two years from diagnosis. Despite efforts to improve survival, the current standard of care continues to be a backbone of radiotherapy with or without temozolomide [Temodar] without much innovation in the past two decades," said Jonathan T. Yang, of Memorial Sloan Kettering Cancer CenterCancer Center, who presented the results.
The study assessed the safety, tolerability, early efficacy and maximum tolerated dose of AZD1390 with IMRT in 115 patients, including 75 with recurrent GBM in arm A and 36 patients with newly diagnosed, MGMT unmethylated GBM in arm C. All patients received escalating once-daily doses of AZD1390. Patients in arm A were given 35 Gy of IMRT in 10 fractions over two weeks while those in arm C were given 60 Gy of IMRT in 30 fractions over six weeks. All patients were given adjuvant AZD1390 for two weeks following the completion of IMRT.
Maximum tolerated doses identified
Of the 115 patients, 15.7% had an AZD1390-related adverse event (AE) of a grade 3 or 4, and 4.3% of patients discontinued AZD1390 due to an AE related to AZD1390 only. The researchers identified 400 mg and 300 mg in arms A and C as the maximum tolerated doses of AZD1390. An overall survival (OS) of 12.7 months was observed in arm A while the OS data for arm C is still maturing.
"Most adverse effects experienced by patients during the study were low grade, readily manageable, and reversible,” Yang said. "If the preliminary efficacy benefit observed in this trial is proven in a pivotal study, it would be a critical, biologically supported approach to address the high unmet need in GBM."
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