Author of

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  P2.01 - Advanced NSCLC (Not CME Accredited Session) (ID 950)

  • Event: WCLC 2018
  • Type: Poster Viewing in the Exhibit Hall
  • Track:
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall

  • 26796

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    P2.01-02 - Osimertinib for EGFR-Positive Advanced NSCLC with Brain Metastases: Preliminary Analysis of an Open-Label, Two-Arm, Phase 2 Study (ID 13020)

    16:45 - 18:00  |  Author(s): Hovav Nechushtan
    • Abstract
    • Slides

    Background
    

    Osimertinib is an EGFR tyrosine-kinase inhibitor (TKI) selective for both EGFR TKI sensitizing and Thr790Met resistance mutations. While intracranial activity of osimertinib was observed in EGFR-mutant NSCLC in larger trials, a study focusing on patients with brain metastases was not reported yet.

    a9ded1e5ce5d75814730bb4caaf49419 Method
    

    This phase 2, open-label, two-arm study enrolled patients with EGFR-mutant, advanced NSCLC and at least one asymptomatic brain metastasis. Treatment-naïve (arm A) and Thr790Met-positive patients who progressed on EGFR-TKI therapy (arm B) received osimertinib 80 mg QD. Dose escalation (160 mg QD) was performed in cases of intracranial progression without symptomatic systemic progression. The primary endpoint was intracranial metastasis response. The trial is ongoing (NCT02736513 at ClinicalTrials.gov) and here we present a preliminary analysis.

    4c3880bb027f159e801041b1021e88e8 Result
    

    Between May 31, 2016, and November 30, 2017 (data cutoff), 20 patients started osimertinib (arm A=15, arm B=5). Median duration of follow-up was 43 weeks. Intracranial response was achieved in 11 (73%; 95% CI 45%-92%) of 15 arm A and in four (80%; 95% CI 28%-99%) of five arm B patients. Dose escalation was performed in four cases (arm A=2, arm B=2), with one continuous response (25%, 95% CI 5%-70%). Ten of 15 patients (67%) in arm A and one of five patients (20%) in arm B continue responding to osimertinib 80 mg at data cutoff. Median intracranial PFS (80 mg) was not available for arm A (95% CI 232 days–NA), and was 510 days in arm B (95% CI 161–not available). Toxic effects were similar to previous reported data.

    8eea62084ca7e541d918e823422bd82e Conclusion
    

    Osimertinib shows equal intracranial and systemic activity with minor side-effects in EGFR-mutant NSCLC as first-line, as well as in previously treated Thr790Met-positive patients. It might therefore be a reasonable treatment for these patient populations and defer brain radiotherapy.

    6f8b794f3246b0c1e1780bb4d4d5dc53

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