Tecentriq Plus Chemo Data Could Re-Enforce Roche's Position In Bladder Cancer
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.
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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.
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.
By granting an approval four months ahead of schedule of Roche AG's and Genentech Inc.'s anti-PD-LI cancer immunotherapy Tecentriq (atezolizumab), the FDA may have helped the companies secure a better lead in the bladder cancer marketplace than the firms otherwise would have held. But already established immunotherapies, Merck & Co. Inc.'s Keytruda (pembrolizumab) and Bristol-Myer Squibb Co.'s Opdivo (nivolumab), are in hot pursuit.