This website uses cookies in order to maximize its functionality and to provide you with better user experience.

Closing this window or continuing to navigate in the website means that you understand and accept the use of cookies in the website. 

Close
Roche Navigation Menu Roche4Med : Roche4Med
  • Sign in
  • Logout
  • Search
Roche
  • Up
  • Home
  • Search
  • Close search

						
							

Searching

    • Home
    • Products
      Products Overview
    • Congresses & Events
      Congresses & Events Overview
    • Comprehensive Genomic Profiling
      Comprehensive Genomic Profiling Overview
    Close

    1 - of results for ""

    No results

    Are you registered? Register now to view Roche scientific information for HCPs!

    • Clinical Data

      Read more

    • Tecentriq®
    • Mechanism of Action
    • Clinical Data
      • Non-small cell lung cancer
    • Dosing & Administration
    • AR Management
    • Resources
      • Professional Resources
      • Congresses
    • Safety Information
    • References
    • More
      • Mechanism of Action
      • Clinical Data
      • Dosing & Administration
      • AR Management
      • Resources
      • Safety Information
      • References

    You are here:

    1. Products
    2. Tecentriq®
    3. Clinical Data
    4. Non-small cell lung cancer
    5. OAK Study Design

    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%



    75%

    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.

    Related Links

    Efficacy

    Safety Profile

    Dosing and Administration

     

    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

    Share
    Close

    Important notice!

    This website is intended for the use of healthcare professionals only, Please approve that you are a healthcare professional in order to continue using this website.

    Accept Cancel
    • © 2021 Roche Pharmaceuticals (Israel) Ltd.
    • 03.08.2020
    • Legal Information

    • Find us on YouTube