Zejula Shows Ability to Treat Range of Advanced Ovarian Cancers in Phase 2 Trial

Zejula Shows Ability to Treat Range of Advanced Ovarian Cancers in Phase 2 Trial
Zejula (niraparib) showed an ability to treat people with recurrent and heavily treated ovarian cancer, particularly those with mutations in DNA repairing genes, results of a Phase 2 trial show. Tesaro’s Zejula is an orally active PARP inhibitor, a class of drugs used for treating cancer in some women who have mutations in BRCA genes. The treatment relies on the notion that cancers with BRCA mutations use other enzymes, like PARP, to repair their DNA. Inhibiting, or blocking, these 'backup' enzymes leads to an accumulation of mutations that is not sustainable, eventually killing cancer cells. While PARP inhibitors works best in BRCA-mutated cancers, there is scientific evidence that some cancers without BRCA mutations may also respond to this type of therapy. Tesaro is evaluating Zejula as a treatment of advanced ovarian and breast cancer in patients with and without BRCA mutations. The treatment is approved in the U.S. and Europe, as a maintenance therapy for epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who have shown a complete or partial response to platinum-based chemotherapy.  Tesaro conducted this Phase 2 trial, called QUADRA (NCT02354586), to evaluate Zejula's efficacy and safety as single treatment for patients with epithelial ovarian cancer who have gone through three or four prior chemotherapy regimens. One of trial's aims is to test this drug in patients that do not carry BRCA mutations. QUADRA, an open-label, single arm study, enrolled 461 patients, who received a starting dose of 300 milligrams of Zejula once a day in a cycle of 28 days. Clinical benefit was assessed by monitoring changes in the patients' quality of life, response to treatment, tumor growth, and adverse events. Most patients, 92
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