Genentech announced that the Food and Drug Administration (FDA) has approved Tecentriq (atezolizumab) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities.
The FDA approval was based on data from the Phase 3 OAK and Phase 2 POPLAR studies. The OAK study (n=1,225) enrolled patients with locally advanced or metastatic NSCLC whose disease had progressed following previous treatment with platinum-containing chemotherapy; the primary analysis included 850 patients. The co-primary endpoints were overall survival (OS) in the intent-to-treat (ITT) population and in a PD-L1-selected subgroup in the primary analysis population. The data showed a longer median OS in patients treated with Tecentriq vs. patients treated with docetaxel (13.8 months vs. 9.6 months, hazard ratio [HR] 0.74, 95% CI: 0.63, 0.87).
The POPLAR study evaluated the safety and efficacy of Tecentriq vs. docetaxel in patients with previously treated recurrent locally advanced or metastatic NSCLC. The primary endpoint was OS. Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), and safety. The data showed a longer median OS in patients treated with Tecentriq vs. patients treated with docetaxel (12.6 months vs. 9.7 months, HR 0.69, 95% CI: 0.52, 0.92).
Tecentriq, a monoclonal antibody, is already indicated to treat patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. It is available as a 60mg/mL solution for IV infusion.
For more information call (888) 835-2555 or visit Tecentriq.com.