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    Uro Pipeline: FDA accepts two supplemental applications for mUC agent

     

    Study to examine effects of vaccine/immunotherapy combo in mUC

    Bavarian Nordic and Roche have reached an agreement in which Roche will supply its PD-L1 blocking antibody, atezolizumab (Tecentriq) for a clinical study involving the use of atezolizumab in combination with CV301, Bavarian Nordic’s cancer vaccine. The study will examine the effects on patients with locally advanced or metastatic urothelial carcinoma and have had disease progression during or following platinum-containing chemotherapy. The phase II study will evaluate the hypothesis that combining a checkpoint inhibitor with a cancer vaccine could be synergistic by enhancing the patient’s immune response. Under the agreement, Roche will supply atezolizumab for the study and Bavarian Nordic is responsible for conducting the study, but both companies with share data from the trial.

     

    Study initiated to examine utility of genomic test in prostate Ca treatment decisions

    GenomeDx Biosciences has begun a prospective, randomized controlled trial to evaluate the utility of Decipher Prostate Cancer Classifier, a commercially available genomic test. The test examines gene activity in prostate cancer cells in order to predict whether or not a patient’s cancer will metastasize. The study, known as the Genomics in Michigan Impacting Observation or Radiation (G-MINOR) trial, is being conducted by the Michigan Urological Surgery Improvement Collaborative (MUSIC). The primary endpoint of the study is to determine the degree to which Decipher may help decide if additional radiation treatment is needed after prostate surgery. The collected data from the study will be added to GenomeDx’s genomic expression database, Decipher GRID. The study is open to men with a high risk of cancer recurrence who have undergone a radical prostatectomy at a participating MUSIC site within the past year.

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    Ben Schwartz
    Ben Schwartz is Associate Editor, Contemporary OB/GYN.

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