Treatment with atezolizumab resulted in a statistically significant and clinically relevant improvement in overall survival, in contrast with docetaxel, among patients with 2L/3L non-small cell lung cancer (NSCLC), according to findings presented at the European Society for Medical Oncology (ESMO) 2016 Congress.1
Atezolizumab is a fully humanized anti-PD-L1 monoclonal antibody that demonstrated a survival benefit versus docetaxel among patients with 2L/3L NSCLC in the phase 2 POPLAR study. Researchers therefore evaluated the efficacy and safety of atezolizumab compared with docetaxel in this patient population in a phase 3 trial.
For the multicenter, open-label OAK study (ClinicalTrials.gov Identifier: NCT02008227), investigators enrolled 1225 patients with previously treated NSCLC. Of those, 25% had received 2 prior lines of therapies, 26% had squamous histology, 67% were former smokers, and 37% had an ECOG performance status of 0.
In the intention-to-treat population of the first 850 patients, results showed that atezolizumab was associated with a 27% reduction in the risk of death compared with docetaxel (hazard ratio [HR], 0.73; P = .0003). Median overall survival was 13.8 months in the atezolizumab arm and 9.6 months in the docetaxel arm.
Researchers found that atezolizumab improved overall survival irrespective of PD-L1 expression levels, including those with no PD-L1 expression, and squamous/nonsquamous histology.
Median progression-free survival was 2.8 months with atezolizumab versus 4.0 months with docetaxel; overall response rates were 13.6% and 13.4%, respectively.
The safety profile of atezolizumab was consistent with previous reports. The rates of treatment-related grade 3 to 4 adverse events were 15% with atezolizumab and 43% with docetaxel.
- Barlesi F, Park K, Ciardiello F, et al. Primary analysis from OAK, a randomized phase III study comparing atezolizumab with docetaxel in 2L/3L NSCLC. Paper presented at: European Society for Medical Oncology (ESMO) 2016 Congress; October 7-11, 2016; Copenhagen, Denmark.