OAK
Trial question
What is the effect of atezolizumab in patients with previously treated non-small cell lung cancer?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
39.0% female
61.0% male
N = 850
850 patients (330 female, 520 male).
Inclusion criteria: patients with squamous or non-squamous non-small cell lung cancer who had received one to two previous cytotoxic chemotherapy regimens for stage IIIB or IV non-small cell lung cancer.
Key exclusion criteria: history of autoimmune disease, previous treatments with docetaxel, CD137 agonists, anti-CTLA4, or therapies targeting the PD-L1 and PD-1 pathway.
Interventions
N=425 atezolizumab (1200 mg (fixed dose) intravenous every 3 weeks).
N=425 docetaxel (75 mg/m² IV every 3 weeks).
Primary outcome
Overall survival in intention-to-treat population
13.8 months
9.6 months
13.8 months
10.4 months
6.9 months
3.5 months
0.0 months
Atezolizumab
Docetaxel
Significant
increase ▲
Significant increase in overall survival in the intention-to-treat population (13.8 months vs. 9.6 months; HR 1.37, 95% CI 1.15 to 1.61).
Secondary outcomes
No significant difference in progression-free survival in the intention-to-treat population (89% vs. 88%; HR 0.95, 95% CI 0.82 to 1.1).
Safety outcomes
Significant difference in treatment-related grade 3 or 4 adverse events (15% vs. 43%).
Conclusion
In patients with squamous or non-squamous non-small cell lung cancer who had received one to two previous cytotoxic chemotherapy regimens for stage IIIB or IV non-small cell lung cancer, atezolizumab was superior to docetaxel with respect to overall survival in the intention-to-treat population.
Reference
Rittmeyer A, Barlesi F, Waterkamp D et al. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet. 2017 Jan 21;389(10066):255-265.
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