Keytruda, Tecentriq Face Efficacy Questions In Urothelial Cancer
Monotherapy patients with tumors that have low PD-L1 expression experienced decrease survival in two confirmatory trials; however, the immune checkpoint inhibitors’ accelerated approvals are unlikely to be affected pending final results comparing use in combination with chemotherapy to chemo alone.
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Middling data for Roche’s IO plus chemo combo were presented at ESMO, while Seattle's rival drug antibody conjugate posted an impressive Phase I response rate.
Roche's PD-L1 inhibitor Tecentriq in combination with chemotherapy improved progression-free survival in first-line bladder cancer, after the immunotherapy failed a confirmatory trial as monotherapy.
FDA’s decision to restrict use based on the level of PD-L1 expression shows how confirmatory trials for accelerated approval can help to inform and adapt labeling.