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    Uro Pipeline: Phase IIb study begins for intraprostatic localized PCa drug

     

    Company formed to develop agents for OAB, other conditions

    Roivant Sciences has formed Urovant Sciences, a new company focused on developing treatments for urologic conditions. The company’s lead therapeutic candidate is vibegron, an oral ß3-adrenergic agonist being studied for overactive bladder. A completed randomized, placebo- and active comparator-controlled phase III study that enrolled over 1,000 patients conducted outside of the United States met its primary and key secondary endpoints. Urovant plans to initiate a multinational phase III registration program for vibegron in 2017.

     

    Phase III urothelial cancer trial meets primary endpoint

    Eli Lilly and Co. has announced that its phase III RANGE study of ramucirumab (Cyramza), a drug being investigated for the treatment of urothelial cancer, has met its primary endpoint of progression-free survival (PFS). The phase III global, randomized, double-blind, placebo-controlled trial is evaluating ramucirumab in combination with docetaxel in patients with locally advanced or unresectable or metastatic urothelial carcinoma whose disease progressed on or after platinum-based chemotherapy. This the first phase III study to show superior PFS over chemotherapy in a post-platinum setting in urothelial cancer, and ramucirumab is the first antiangiogenic agent to extend PFS in a phase III trial, Lilly said. The safety profile remains unchanged as the analysis was consistent with previous observations of ramucirumab. Grade ≥3 adverse events occurring at a rate of 5% or greater and that were higher on the ramucirumab-plus-docetaxel arm versus the placebo-plus-docetaxel arm were neutropenia, febrile neutropenia and hypertension. Lilly anticipates that, while the primary endpoint has been met, overall survival results will likely be required for global regulatory submission, and these results are expected in mid-2018.

    Next: NDA submitted for new formulation of mCRPC agent

    Ben Schwartz
    Ben Schwartz is Associate Editor, Dermatology Times & Urology Times.

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