Immunomedics announced that the company plans to initiate a Phase 2 pivotal TROPHY U-01 study of sacituzumab govitecan, the company’s lead investigational ADC, as a single agent in patients with locally advanced or metastatic urothelial cancer who have relapsed after a platinum-based regimen and/or immune checkpoint inhibitor therapy. The Phase 2 pivotal study, which is expected to be activated next week, will be a single arm, international, multicenter study that will enroll approximately 100 mUC patients who have received prior platinum-based and CPI treatment. The primary endpoint will be overall response rate, with duration of response, progression-free survival, and overall survival serving as secondary endpoints. Response assessments will be in accordance with RECIST 1.1 and all patients will be centrally reviewed. In addition, the study will also enroll an additional and separate cohort of patients who are cisplatin ineligible and have received prior CPI treatment to evaluate safety and efficacy in an earlier treatment setting.
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