The regulator’s decision was based on results from the randomized randomized Phase III OAK and Phase II POPLAR trials.
The OAK trial enrolled 850 patients with squamous and nonsquamous disease, regardless of PD-L1 status. They were randomized 1:1 to receive either Tecentriq administered intravenously at 1200 mg every three weeks or docetaxel administered intravenously at 75 mg/m 2 every three weeks.
Results demonstrated that patients treated with atezolizumab achieved significantly longer median OS than those treated with docetaxel.
The POPLAR trial enrolled 287 patients assigned atezolizumab (n = 144) or docetaxel (n = 143).
Results showed those assigned atezolizumab achieved significantly longer median objective response.
Objective response rate was similar in the atezolizumab and docetaxel groups The median duration of response was considerably longer among patients assigned atezolizumab.
The most common side effects associated with atezolizumab treatment in patients with metastatic NSCLC include fatigue, decreased appetite, dyspnea, cough, nausea, musculoskeletal pain and constipation.
Genentech chief medical officer and head of global product development Sandra Horning said: “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.
“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.”
Image: Genentech in South San Francisco, USA. Photo: courtesy of F. Hoffmann-La Roche Ltd.