Kazia Therapeutics announced the presentation of data from a Phase I study evaluating concurrent paxalisib and radiation therapy in patients for the treatment of solid tumor brain metastases or leptomeningeal metastases harboring PI3K pathway mutations at the American Society for Radiation Oncology 66th Annual Meeting, ASTRO 2024, which is taking place from September 29 – October 2, 2024, in Washington, D.C. Summary Results from Part II of Phase 1 Study: Concurrent daily administration of paxalisib with brain radiotherapy was generally well-tolerated at a maximum dose of 45 mg per day in advanced solid tumor patients with brain metastases and PI3K pathway mutations; The most commonly reported adverse events in the study were nausea, vomiting and hyperglycemia; Established proof-of-principle for molecularly-selected, rational combination studies in radiation oncology to assess safety and ultimately efficacy; Treatment with 45mg paxalisib and radiotherapy demonstrated a 67% PR; and Over two-thirds of the patients at MTD achieved intracranial response which compares favorably to historical response rates for WBRT alone.
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