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IMvigor010 was the first randomized Phase III study of TECENTRIQ compared to chemotherapy in people with advanced bladder cancer who were previously treated with a platinum-based chemotherapy. The study evaluated the efficacy and safety of TECENTRIQ compared to chemotherapy (vinflunine, paclitaxel or docetaxel) administered every three weeks in people with previously-treated mUC who progressed during or following a platinum-based regimen.
Eligible patients had an Eastern Cooperative Oncology Group performance status of 0-1, an evaluable tumor sample for centralised PD-L1 testing and had received at least one prior therapeutic regimens for mUC or who had developed mUC within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). The primary efficacy endpoint was OS and key secondary endpoints include objective response rate, progression-free survival, duration of response and safety.