FDA approves Roche’s cancer immunotherapy TECENTRIQ (atezolizumab) for people with a specific type of metastatic lung cancer.
Roche said that this approval is based on results from the randomised Phase III OAK and Phase II POPLAR studies. The largest study, OAK, showed that TECENTRIQ helped people in the overall study population live a median of 13.8 months, 4.2 months longer than those treated with docetaxel chemotherapy (median overall survival [OS]: 13.8 vs. 9.6 months; HR = 0.74, 95% CI: 0.63, 0.87). The study enrolled people regardless of their PD-L1 status and included both squamous and non-squamous disease types.
“TECENTRIQ is a new option to help people with this type of previously treated metastatic lung cancer, regardless of PD-L1 expression, live longer than chemotherapy” said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development and added: “TECENTRIQ is the first and only approved cancer immunotherapy designed to target the PD-L1 protein, which may play an important role in the way the medicine works.”
The TECENTRIQ development programme includes more than 15 clinical trials in lung cancer, including seven phase III studies in previously untreated (first-line) lung cancer. These studies are evaluating the use of TECENTRIQ alone or in combination with other medicines, said Roshe.