Kazia Therapeutics released secondary overall survival (OS) data from its Phase II/III GBM-AGILE trial, as it seeks the FDA’s accelerated approval for its drug paxalisib.
The trial, GMB-AGILE, has been designed as a test for several investigational glioblastoma therapies as opposed to the current standard of care.
About Kazia’s Focus
Kazia’s focus moved on to newly diagnosed glioblastoma patients where paxalisib represents a median overall survival of 14.77 months. This is longer than its predecessor temozolomide with an OS of 13.84 months.
About Glioblastoma
It is estimated that about 20,000 people in the U.S. are reportedly diagnosed with cancer originating in the brain. Glioblastoma is the most common form of brain cancer.
Researchers are striving to develop better treatment strategies to improve not only survival but also the quality of life for glioblastoma patients. Currently, even with aggressive treatment, patients may only survive about a year after diagnosis.
About Paxalisib
Paxalisib was originally developed by Genentech. It inhibits P13K action and provides a survival benefit over the standard of care in newly diagnosed glioblastoma patients.
Researchers found a key signaling pathway, PI3K-beta, which is responsible for chemotherapy resistance in glioblastoma. When this pathway is blocked, it makes tumor cells more sensitive to the drug temozolomide, a standard chemotherapy drug.
The discovery offers a potentially new approach to treat glioblastoma, a deadly brain cancer, by overcoming drug resistance and improving patient outcome
Drug resistance remains one of the major problems in cancer therapy and is responsible for up to 90% of cancer-related deaths. It exists across all types of cancer and treatment.
Determining how to overcome this problem is a goal that involves understanding biological mechanisms and includes clinical trials to test new therapeutic strategies. The study GBM-Agile is a large global study that is designed to test several investigational glioblastoma treatments versus current standard of care.
But drug resistance is still a major problem in cancer therapy. It is responsible for approximately 90% of deaths related to cancer. Therefore, determining how to overcome this problem becomes a goal that requires understanding of the biological mechanisms including clinical trials that put therapeutic strategies to the test.
Paxalisib inhibits P13K which is central to division and cell growth. It is unlike most P13K blockers, as it can cross the blood-brain barrier. This enables P13K to attack malignancies of the CNS.
The GBM-AGILE study is designed to investigate several treatments against the standard of care. The study used chemotherapy with temozolomide for the newly diagnosed patients. Patients with recurrent disease received lomustine. The primary endpoint was OS.
Not as Expected
Reports were disappointing. Paxalisib was unable to show any signs of efficacy. The median OS was 8.05 in treated patients. These numbers compare to a 9.69-month OS in lomustine treated patients. The company had no choice but to enter into a deeper analysis to clarify signs for additional consideration.
A New Subset
Currently, Kazia is now focused on newly diagnosed glioblastoma patients. In this subset, paxalisib showed an OS of 14.77 months, somewhat longer than its temozolomide counterparts. An additional group of patients from the GMB-AGILE study were tested. In this group the median OS for paxalisib increased to 15.54 months versus the control which dipped to 11.89 months.
John Friend, Kazia CEO, addressed the survival difference as exciting as it translates into approximately 33% or a 3.8-month improvement in OS for unmethylated patients as opposed to the current standard of care. Note that non mentholated means that a person may not benefit from chemotherapy.
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brain cancer glioblastoma research treatment
Last modified: August 15, 2024
