The phase 3 OAK trial — designed to evaluate atezolizumab in patients with locally advanced or metastatic non–small cell lung cancer whose disease progressed on or after treatment with platinum-based chemotherapy — met its co-primary endpoints, according to the drug’s manufacturer.
Researchers of the multicenter, open-label controlled study randomly assigned 1,225 patients 1:1 to receive 1,200 mg IV infusion of atezolizumab (Tecentriq, Roche) or 75 mg/m² IV infusion of docetaxel every 3 weeks.
Researchers evaluated patients’ PD-L1 expression both tumor cells and tumor-infiltrating cells with an investigational immunohistochemistry (IHC) test based on the SP142 antibody under development by Roche Tissue Diagnostics. IHC scores of 1/2/3 on tumor cells or tumor-infiltrating cells defined PD-L1 expression.
OS in all patients randomly assigned to the intent-to-treat population as well as in a PD-L1–selected subgroup of patients served as the co-primary endpoints.
Secondary endpoints included overall response rate, PFS and duration of response.
Atezolizumab conferred statistically significant and clinically meaningful improvements in OS in the intent-to-treat population as well as in the PD-L1–selected subgroup compared with docetaxel chemotherapy.
The researchers observed no new adverse events.
“These results add to the growing body of evidence that supports the role of atezolizumab as a potential new treatment for specific types of advanced NSCLC,” Sandra Horning, MD, chief medical officer and head of Global Product Development at Roche, said in a press release. “This is very encouraging news for people living with this disease because lung cancer is the leading cause of cancer deaths around the world. We hope to bring this treatment option to patients as soon as possible.”