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GSK, Ivy Brain Tumor Center to Begin Phase III Trial of Zejula in MGMT Unmethylated Glioblastoma

NEW YORK – GlaxoSmithKline and the Ivy Brain Tumor Center at Barrow Neurological Institute in Arizona on Thursday announced plans to begin a Phase III trial evaluating GSK's PARP inhibitor Zejula (niraparib) in adult patients with newly diagnosed MGMT-unmethylated glioblastoma.

The Phase III randomized study will compare Zejula to the standard-of-care chemotherapy temozolomide in 450 patients. The primary endpoints of the study are progression-free and overall survival.

GSK and the Ivy Center have decided to move forward with a Phase III trial after a Phase 0/II trial of Zejula yielded promising results in this setting. In that earlier study, median overall survival on Zejula was 20.3 months, a significant increase compared to the median 12.7 months overall survival in historical controls. The Phase 0/II study also confirmed that Zejula crosses the blood-brain barrier. Researchers will present the full data from the Phase 0/II trial at the American Society of Clinical Oncology's annual meeting in June.

"This hybrid Phase 0/II study provides simultaneous biological and clinical data identifying niraparib as a best-in-class brain-penetrant molecule with promising radiosensitizer effects in glioblastoma," Nader Sanai, director of the Ivy Brain Tumor Center, said in a statement, adding that Zejula could eventually become a "new standard of care for MGMT-unmethylated glioblastoma patients."

Zejula is approved in the US as a maintenance therapy for advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer patients and for recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer patients with a germline BRCA1/2 mutation.