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Bending the Curve Trial by Trial
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OAK

Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer

Phase 3N = 1,225NCT02008227

Population
Squamous or non-squamous NSCLC after one to two previous cytotoxic regimens (at least one platinum-based) for stage IIIB or IV disease; ECOG performance status 0 or 1
Design
Randomised (1:1), open-label, multicentre phase 3 trial at 194 centres in 31 countries. Atezolizumab 1200 mg or docetaxel 75 mg per square metre every 3 weeks. The primary efficacy analysis was done in the first 850 of 1225 enrolled patients (425 per arm).
Primary endpoint
OS
Arms
  • Atezolizumab (experimental): Atezolizumab 1200 mg every 3 weeks
  • Docetaxel (control): Docetaxel 75 mg per square metre every 3 weeks
People
Rittmeyer A, OAK Study Group
OSHR 0.73 (95% CI 0.62–0.87)Δ median OS+4.2 monthsOSHR 0.74 (95% CI 0.58–0.93)Δ median OS+5.4 monthsOSHR 0.75 (95% CI 0.59–0.96)Δ median OS+3.7 months
Show the numbers
Results reported for OAK
EndpointAnalysisAtezolizumabDocetaxelEffect
OSITT (primary analysis in the first 850 randomised patients)primaryRittmeyer 2017median 13.8 months (11.8–15.7)median 9.6 months (8.6–11.2)HR 0.73 (95% CI 0.62–0.87)P=0.0003Coprimary endpoints were OS in the ITT population and in the PD-L1-expression population (TC1/2/3 or IC1/2/3). Treatment-related grade 3 or 4 adverse events: 15% (90 of 609) vs 43% (247 of 578).
OSPD-L1 on at least 1% of tumour cells or tumour-infiltrating immune cells (TC1/2/3 or IC1/2/3)primaryRittmeyer 2017median 15.7 months (12.6–18.0)median 10.3 months (8.8–12.0)HR 0.74 (95% CI 0.58–0.93)P=0.0102n=241 (atezolizumab) and 222 (docetaxel).
OSPD-L1 low or undetectable subgroup (TC0 and IC0)exploratoryRittmeyer 2017median 12.6 monthsmedian 8.9 monthsHR 0.75 (95% CI 0.59–0.96)Subgroup of the ITT population, not a coprimary comparison; the abstract gives no P value or confidence intervals for the medians.
Results reported for OAK
EndpointAnalysisAtezolizumabDocetaxelEffect
OSITT (primary analysis in the first 850 randomised patients)primaryRittmeyer 2017median 13.8 months (11.8–15.7)median 9.6 months (8.6–11.2)HR 0.73 (95% CI 0.62–0.87)P=0.0003Coprimary endpoints were OS in the ITT population and in the PD-L1-expression population (TC1/2/3 or IC1/2/3). Treatment-related grade 3 or 4 adverse events: 15% (90 of 609) vs 43% (247 of 578).
OSPD-L1 on at least 1% of tumour cells or tumour-infiltrating immune cells (TC1/2/3 or IC1/2/3)primaryRittmeyer 2017median 15.7 months (12.6–18.0)median 10.3 months (8.8–12.0)HR 0.74 (95% CI 0.58–0.93)P=0.0102n=241 (atezolizumab) and 222 (docetaxel).
OSPD-L1 low or undetectable subgroup (TC0 and IC0)exploratoryRittmeyer 2017median 12.6 monthsmedian 8.9 monthsHR 0.75 (95% CI 0.59–0.96)Subgroup of the ITT population, not a coprimary comparison; the abstract gives no P value or confidence intervals for the medians.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OSOSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.730.62–0.87
OS0.740.58–0.93
OS0.750.59–0.96
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%051015202530Months (modelled)
  • Atezolizumab (experimental)
  • Docetaxel (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsAtezolizumabDocetaxel
0100.0%100.0%
963.6%52.2%
1742.6%29.3%
2627.1%15.3%
3517.2%8.0%
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%0102030Months (modelled)
  • Atezolizumab (experimental)
  • Docetaxel (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsAtezolizumabDocetaxel
0100.0%100.0%
1064.3%51.0%
2041.4%26.0%
2927.8%14.2%
3917.9%7.2%
Primary publication: Rittmeyer A, Barlesi F, Waterkamp D, Park K, Ciardiello F, von Pawel J, 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;389(10066):255-265. PubMedDOI

Appears in

Sources

  1. Rittmeyer A, Barlesi F, Waterkamp D, Park K, Ciardiello F, von Pawel J, 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;389(10066):255-265.

    PubMedDOI