Zejula Cuts Tumor Burden in Significant Proportion of Advanced PC Patients

Zejula Cuts Tumor Burden in Significant Proportion of Advanced PC Patients
Four in 10 adults with metastatic castration-resistant prostate cancer (mCRPC) and BRCA mutations respond to treatment with Zejula (niraparib), according to early results of an ongoing Phase 2 trial. The GALAHAD study (NCT02854436), sponsored by Janssen, is testing 300 mg daily Zejula in patients whose disease worsened after treatment with next-generation androgen-receptor signaling therapies — a mainstay in the treatment of prostate cancer — and the chemotherapy docetaxel. All participants tested positive for a mutation in one of eight DNA repair genes. Patient enrollment is ongoing at multiple locations. More information on study sites and contacts can be found here. A total of 120 patients have already been recruited, with an estimated total of 301. As of the analysis cutoff date, the trial had enrolled 50 patients with a defect in both copies of a DNA repair pathway gene, 29 of whom had BRCA1/2 mutations — the most common in people with mCRPC — and 21 with alterations in other genes. Zejula reduced tumor burden in 38% of those with BRCA1/2 mutations. It also led to a 62% composite response rate, defined by a reduction in tumor burden, the quantity of circulating tumor cells, or a 50% or greater decline in PSA levels. Patients with non-BRCA1/2 mutatio
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