Roche’s (RHHBY) Tecentriq (atezolizumab), a PD-L1 blocker is approved for use in the treatment of individuals with metastatic urothelial carcinoma in patients. These patients would not be eligible candidates for cisplatin-containing chemotherapy, or showed disease progression after treatment with platinum-containing chemotherapy.
Tecentriq has also been approved for metastatic non-small cell lung cancer (or NSCLC) in patients who demonstrated disease progression after platinum-containing chemotherapy.
Roche is conducting phase 3 IMpower 131 trial to evaluate the safety and efficacy of Tecentriq, carboplatin and nab-paclitaxel/paclitaxel in the first-line setting compared to chemotherapy alone (carboplatin and paclitaxel) in individuals with stage IV squamous NSCLC.
In March, Roche announced that the phase 3 IMpower trial met its co-primary endpoint of PFS (progression-free survival). In the clinical trial, Tecentriq containing regimen decreased the risk of disease worsening or death compared to the chemotherapy regimen.
In May, the FDA accepted Roche’s supplemental Biologics License Application (or sBLA) for Tecentriq in combination with Avastin, paclitaxel, and carboplatin for the first-line treatment of individuals with metastatic non-squamous NSCLC. The FDA granted Roche’s sBLA a priority review and provided a PDUFA (Prescription Drug User Fee Act) action date of September 5.
Roche’s sBLA was supported by data from the phase 3 IMpower 150 trial. The phase 3 IMpower 150 trial met its co-primary endpoints of OS (overall survival) and PFS (progression-free survival). The approval of Roche’s sBLA will help in label expansion of Tecentriq. The label expansion of Tecentriq could significantly boost the revenue growth of the drug in 2018 and beyond.
According to American Cancer Society estimates, 234,030 new cases of lung cancer and 154,050 deaths due to lung cancer are anticipated in 2018 in the United States. The statistics depict the large patient population in the United States. Studies also estimate that NSCLC is the most common type of lung cancer and accounts for 85% of all lung cancers.