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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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.
Roche's broad cancer immunotherapy pipeline features a dozen novel agents, including the first candidates from new therapeutic platforms for bispecific antibodies and personalized cancer vaccines.