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 mutations showed a 13% objective response rate and a 24% composite response rate. Nearly half the patients have been on treatment for at least six months without disease progression. The most frequent serious to life-threatening adverse events were blood-related, including low levels of red blood cells, platelets, neutrophils, or white blood cells. Other serious adverse events included lack of energy and strength and back pain. The results were presented at the recent American Society o
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