Author of

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  OA07 - Oligometastasis: What Should Be the State-Of-The-Art? (ID 905)

  • Event: WCLC 2018
  • Type: Oral Abstract Session
  • Track: Oligometastatic NSCLC
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/24/2018, 15:15 - 16:45, Room 107

  • 25838

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    OA07.01 - Phase II Study of Pembrolizumab for Oligometastatic Non-Small Cell Lung Cancer (NSCLC) Following Completion of Locally Ablative Therapy (LAT) (ID 12590)

    15:15 - 15:25  |  Author(s): Christina Knepley
    • Abstract
    • Presentation
    • Slides

    Background
    

    Patients (pts) with oligometastatic NSCLC may benefit from LAT (e.g., surgery, stereotactic radiation (SRT)). It is unclear if systemic therapy can provide benefit after LAT. We completed a Phase II study evaluating the efficacy of pembrolizumab after LAT, hypothesizing that immunotherapy would be effective in the setting of a minimal disease burden.

    a9ded1e5ce5d75814730bb4caaf49419 Method
    

    Eligibility stipulated oligometastatic NSCLC (up to 4 sites) with completion of LAT to all known sites of disease. Within 4-12 weeks of completing LAT, pts began pembrolizumab 200 mg every 21 days for 6 mos, with a provision to continue for up to a year in the absence of progression (PD) or toxicity. Progression-free survival (PFS) and overall survival (OS) were measured from the start of LAT. A sample size of 42 pts would provide 80% power for a test at 5% 1-sided type I error to increase PFS to >=10 mos compared to a historical control PFS of 6.6 mo.

    4c3880bb027f159e801041b1021e88e8 Result
    

    Since January 2015, 45 pts have been enrolled. Median age is 64 years; 53% male; 89% Caucasian; 89% current and former smokers. Most common metastatic sites are lung (16 pts), brain (18), liver (9), and bone (9). LAT included surgery (30 pts), SRT (30), and chemoradiotherapy (23). Adverse events have been mostly mild. There were two episodes of Grade 3 pneumonitis, two episodes of Grade 3 colitis, and one episode of Grade 3 adrenal insufficiency. Median follow-up from start of LAT is 20.1 mos. To date, 19 pts have had PD or died. Median PFS was 25 mos. PFS rates (+ SE) at 12, 18 and 24 mos are 72%+7%, 54%+9% and 50%+9%, with 10 free of PD/death beyond 24 mos. To date, 10 pts have died. Median OS has not yet been reached. OS rates (+ SE) at 12, 18 and 24 mos are 91%+4%, 82%+7% and 73%+8%, with 14 pts alive beyond 24 mos. Median PFS was 16.9 mos for pts with metachronous disease (n=33), not yet reached for pts with synchronous disease (n=12). Median OS has not yet been reached in either group.

    8eea62084ca7e541d918e823422bd82e Conclusion
    

    Pembrolizumab after LAT for oligometastatic NSCLC is feasible and well tolerated. PFS appears quite favorable, preliminarily Final analysis will be performed September 2018. Updated survival estimates and biomarker data will be presented.

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