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Johnson and Johnson Pharmaceuticals today published the results of a randomized, double-blind, placebo-controlled Phase III clinical (ACIS study) that reached the primary endpoint of radiological progression-free survival (rPFS), reducing the risk of death in patients with primary metastatic desopathic prostate cancer (mCRPC) by 31 percent.
patients who had not been tested were treated with ERLEADA®/ZYTIGA®/Pernisson (combined drug group), or placebo/ZYTIGA®/Pernisson (control group).
results will be presented at the American Society of Clinical Oncology Urology (ASCO GU) symposium.
preliminary efficacy analysis showed that the mid-level rPFS in the combined group was extended by 6 months (22.6 vs. 16.6 months, with a risk ratio of 0.69, 95% CI 0.58-0.83, p.lt;0.0001) compared to the control group.
the latest analysis of 54.8 months of mid-level follow-up, the combined group had a 30 percent lower risk of imaging progress or death than the control group.
there was no statistically significant difference between the two groups for secondary endpoints, including total lifetime (OS), the time to start cytotoxic chemotherapy, and so on.
Dana Rathkopf, of memorial Sloan Kettering Cancer Center, said: "The data from the ACIS study show a significant increase in rPFS in the evaluation of the treatment of ERLEADA and ZYTIGA combined with Pernisone for metastatic desirable resistance to prostate cancer."
