Roche said Thursday that a Phase III study of the anti-PD-L1 immunotherapy Tecentriq (atezolizumab) in certain people with locally advanced or metastatic non-small-cell lung cancer (NSCLC) met its co-primary endpoints and showed a significant and clinically meaningful improvement in overall survival versus docetaxel.
The OAK trial randomised 1225 patients with locally advanced or metastatic NSCLC whose disease progressed on or after treatment with platinum-containing chemotherapy to receive either docetaxel or Tecentriq every three weeks. Roche noted that the primary efficacy analysis was based on the first 850 randomised patients, while the secondary efficacy analysis will include all subjects enrolled in the study.
The trial's co-primary endpoints were overall survival in all patients randomised to treatment in the study and in a PD-L1 selected subgroup of people. Meanwhile, secondary endpoints include objective response rate, progression-free survival and duration of response. Roche said that adverse events in the trial were "consistent" with those previously observed for Tecentriq, adding that further data will be presented at an upcoming medical meeting in 2016.
In April, the FDA granted priority review to an application seeking approval of Tecentriq for the treatment of people with PD-L1-positive NSCLC whose disease has progressed during or after platinum-based chemotherapy, with a target action date of October 19. Meanwhile, the drug was awarded accelerated approval by the agency in May for the treatment of locally advanced or metastatic urothelial carcinoma.
For further analysis, read ViewPoints: Roche throws curveball with Tecentriq data, and KOL Views: CheckMate-026 results open window of opportunity for Roche, though Tecentriq’s ability to capitalise far from certain. See also, KOL Insight NSCLC: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.
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