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The trial that put a PD-L1 antibody alongside the PD-1 antibodies as second-line treatment for lung cancer, in the largest second-line immunotherapy trial run.
OAK recruited 1,225 patients at 194 centres in 31 countries between March 2014 and April 2015 and randomised them 1:1 to atezolizumab 1200 mg or docetaxel 75 mg/m2 every three weeks. Eligible patients had squamous or non-squamous disease, performance status 0 or 1, and one or two previous cytotoxic regimens including at least one platinum combination; patients with autoimmune disease or previous checkpoint exposure were excluded. The primary efficacy analysis was prespecified in the first 850 enrolled, 425 per arm, with co-primary endpoints in the intention-to-treat population and in the PD-L1-expressing population (1 percent or more on tumour cells or tumour-infiltrating immune cells).
Median overall survival was 13.8 months (95 percent confidence interval 11.8 to 15.7) with atezolizumab against 9.6 months (8.6 to 11.2) with docetaxel (hazard ratio 0.73). The benefit held in both co-primary populations, including in patients whose tumours had no detectable PD-L1.
The FDA approved atezolizumab for metastatic non-small-cell lung cancer after platinum chemotherapy in 2016. In England NICE TA520 (16 May 2018) recommends atezolizumab after chemotherapy for locally advanced or metastatic disease.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
1,225 randomised.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival (intention to treat)primary | Atezolizumab | 425 | 13.8 months | 0.73 | - | link |
| Docetaxel | 425 | 9.6 months |
Shares Immune checkpoint, Adenocarcinoma of the lung, Atezolizumab, Roche / Genentech.
Shares PD-L1 expression testing (22C3, SP142, SP263), Atezolizumab, Roche / Genentech, PD-L1.
Shares Squamous cell carcinoma of the lung, Adenocarcinoma of the lung, Docetaxel, Lung cancer (all types).
Shares Immune checkpoint, Squamous cell carcinoma of the lung, Adenocarcinoma of the lung, Lung cancer (all types).
Shares Immune checkpoint, Atezolizumab, Roche / Genentech, PD-L1.
Shares Adenocarcinoma of the lung, Docetaxel, Lung cancer (all types), Cytotoxic chemotherapy.
Shares Atezolizumab, Roche / Genentech, Immune checkpoint inhibitors, Non-small-cell lung cancer.
Shares PD-L1 expression testing (22C3, SP142, SP263), Atezolizumab, Roche / Genentech, PD-L1.