Avastin Redux? Genentech’s Tecentriq Trial Failure Puts Bladder Cancer Claim At Risk
Confirmatory trial misses overall survival primary endpoint, raising question of whether US FDA will seek to revoke accelerated approval of PD-L1 inhibitor’s second-line bladder cancer indication, as it did with Avastin’s breast cancer claim.
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Bladder Cancer Accelerated Approvals: Merck’s Keytruda and Genentech’s Tecentriq Each May Have One Last Lifeline
US FDA will ask advisory committee whether data from the trial supporting full approval of Merck’s Keytruda for second-line setting can be used to confirm clinical benefits for earlier setting of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy following a failed confirmatory study. Genentech’s Tecentriq is also at risk of losing its accelerated approval in that space but it could buy some time as its confirmatory study is not yet complete. New competitor entrant since accelerated approvals also lessens degree of unmet need.
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.
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.