Atezolizumab demonstrated improved overall survival (OS) compared to docetaxel for patients with unselected non-small cell lung cancer (NSCLC) who failed prior chemotherapy, according to results from a phase 3 trial presented at the International Association for the Study of Lung Cancer (IASLC) 17th Annual World Conference on Lung Cancer in Austria.1
The results of the phase 3 OAK (ClinicalTrials.gov Identifier: NCT02008227) study found that OS was improved with atezolizumab regardless of histology and PD-L1 expression among both never-smokers and patients with brain metastases.
Primary analysis of the OAK study in patients with previously-treated NSCLC found improved median OS for atezolizumab (13.8 months) compared to docetaxel (9.6 months) in the intention-to-treat (ITT) population and among patients expressing greater than 1% PD-L1 on tumor cells or immune cells.
The subgroup analyses evaluated the OAK results for an unselected population with NSCLC who had failed prior platinum-containing chemotherapy. Patients were stratified by PD-L1 expression, prior chemotherapy regimens, and histology, and were randomized 1:1 to atezolizumab or docetaxel.
For the first 850 of 1225 randomized patients (primary study population), OS was improved with atezolizumab vs docetaxel regardless of histology; this benefit was observed across PD-L1 subgroups within each histology.
Among patients with non-squamous NSCLC, overall response rate (ORR) was 14.4% with atezolizumab compared to 15.2% with docetaxel; in squamous NSCLC, ORRs were 11.6% and 8.2%, respectively.
Patients with treated baseline brain metastases (85) who were treated with atezolizumab had a median OS of 20.1 months, compared to 11.9 months for docetaxel. Never-smokers (156 patients) had a median OS of 16.3 months when treated with atezolizumab compared to 12.6 months for docetaxel.
- Gadgeel SM, Ciardiello F, Rittmeyer A, et al. OAK, a randomized phase III study of atezolizumab vs docetaxel in patients with advanced NSCLC: results from subgroup analyses. Paper presented at: International Association for the Study of Lung Cancer 17th World Conference on Lung Cancer; December 2016; Vienna, Austria.