OAK Study Design
SURVIVAL BENEFIT ESTABLISHED VERSUS STANDARD OF CARE
OAK: the largest Phase III cancer immunotherapy study in previously treated advanced NSCLC, regardless of PD-L1 expression1,2
Multicentre, international, randomised, open-label trial evaluating TECENTRIQ versus docetaxel.
Primary endpoint
- Overall survival (OS)
- OAK enrolled patients with non-squamous and squamous histologies and different levels of PD-L1 expression2,3
IV=intravenous; q3w=every 3 weeks.
*The primary analysis population consisted of the first 850 randomised patients.
†The study excluded patients who had a history of autoimmune disease, active or corticosteroid-dependent brain metastases, administration of a live, attenuated vaccine within 28 days prior to enrolment, and administration of systemic immunostimulatory agents within 4 weeks, or systemic immunosuppressive medicinal product within 2 weeks, prior to enrolment.
| Patient characteristics | TECENTRIQ (n=425) | Docetaxel (n=425) |
Patient demographics Median age (range) Male White |
63 (33-82) 61% 71% |
64 (34-85) 61% 70% |
Histology Non-squamous Squamous |
74% 26% |
74% 26% |
| EGFR mutation | 10% | 10% |
| Known ALK rearrangements | <1% | 0% |
| Current or previous smoker | 80% | 83% |
ECOG performance status 0 1 |
36% 64% |
38% 62% |
Number of prior therapies, advanced setting 1 2 |
75% 25% |
25% |
PD-L1 expression level TC ≥50% or IC ≥10% TC or IC ≥5% TC or IC ≥1% TC and IC<1% |
17% 30% 57% 42% |
15% 32% 52% 47% |
ALK=anaplastic lymphoma kinase; ECOG=Eastern Cooperative Oncology Group; EGFR=epidermal growth factor receptor; IC=tumour-infiltrating immune cell; TC=tumour cell.
References:
1. TECENTRIQ prescribing information.
2. Rittmeyer A, Barlesi F, Waterkamp D, et al; OAK Study Group. 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;389:255-265.
3. Rittmeyer A, Barlesi F, Waterkamp D, et al; OAK Study Group. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial [published online December 12, 2016] [supplementary appendix]. Lancet.doi:10.1016/S0140-6736(16)32517-X.
MatCode Approval Code: -1905-V2-3253