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Silevertinib + temozolomide is a combination therapy being developed by Black Diamond Therapeutics for the treatment of newly diagnosed glioblastoma (GBM). Silevertinib (BDTX-1535) is an oral, brain-penetrant, selective fourth-generation small molecule EGFR inhibitor designed as a MasterKey therapy to target a broad spectrum of oncogenic EGFR mutations, including EGFRvIII and extracellular domain mutations. Temozolomide is an oral alkylating agent that serves as the standard of care for GBM. The combination is currently being evaluated in a Phase 2 clinical trial as maintenance therapy for patients with newly diagnosed glioblastoma harboring EGFRvIII mutations and an unmethylated MGMT promoter, aiming to improve progression-free survival by addressing the high prevalence of EGFR alterations in this patient population.
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