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Alexander Todd



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    OA07 - Precision Medicine Involves Biology and Patients (ID 132)

    • Event: WCLC 2019
    • Type: Oral Session
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
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      OA07.01 - Osimertinib Plus Platinum/Pemetrexed in Newly-Diagnosed Advanced EGFRm-Positive NSCLC; The Phase 3 FLAURA2 Study (Now Available) (ID 2383)

      11:00 - 12:30  |  Author(s): Alexander Todd

      • Abstract
      • Presentation
      • Slides

      Background

      Osimertinib is a third-generation, CNS-active EGFR-TKI that potently and selectively inhibits both sensitizing EGFR and T790M mutations. Osimertinib is considered the standard of care for patients with newly-diagnosed advanced/metastatic NSCLC harbouring EGFR-activating mutations, based on results of the phase 3 FLAURA trial, which demonstrated a statistically and clinically significant progression-free survival (PFS) benefit for osimertinib over erlotinib or gefitinib. Evidence indicates that adding chemotherapy to gefitinib improves efficacy outcomes versus EGFR TKI monotherapy in newly-diagnosed patients with EGFRm NSCLC (Nakamura et al JCO 2018;36:9005). Adding platinum/pemetrexed to osimertinib could further improve outcomes for newly-diagnosed patients with EGFRm-positive NSCLC.

      Method

      The phase 3, open-label, FLAURA2 study aims to assess the efficacy and safety of osimertinib plus cisplatin/carboplatin plus pemetrexed in adults with locally-advanced/metastatic EGFRm-positive (Ex19del and/or L858R) NSCLC who have not received prior therapy for advanced disease. Patients are required to have a WHO performance status (PS) 0-1, life expectancy >12 weeks and not be amenable to curative surgery or radiotherapy. An initial non-randomised run-in phase (n=30) will assess the safety and tolerability of osimertinib 80 mg once daily (QD) with either cisplatin or carboplatin, and pemetrexed, both administered every 3 weeks (Q3W) for 4 cycles, followed by osimertinib 80 mg QD plus pemetrexed maintenance Q3W until progression or discontinuation. Based on evaluation of safety data from the run-in after ≥12 patients from each group have received ≥3 cycles of study treatment or discontinued therapy, the second phase will randomise approximately 556 patients 1:1 to receive osimertinib 80 mg QD with pemetrexed and cisplatin/carboplatin for 4 cycles followed by osimertinib plus pemetrexed maintenance Q3W or osimertinib alone (80 mg QD), to be continued until progression or discontinuation. Randomisation will be stratified by race (Chinese/Asian vs. non-Chinese/Asian vs. non-Asian), WHO PS (0 vs. 1), and tissue EGFR mutation test at enrolment (cobas® EGFR Mutation Test vs local assessment). A futility analysis of the randomized phase is planned for when approximately 83 PFS events have occurred. The primary endpoint is PFS based on investigator assessment of response using RECIST 1.1 criteria (blinded central assessment is included as a sensitivity analysis). Secondary endpoints include overall survival, objective response rate, duration of response, PFS2, health-related quality of life and safety. Effects on CNS metastases in patients with lesions at baseline will be included as an exploratory endpoint. Enrolment is planned for Q3 2019 for the safety run-in and Q1 2020 for the randomized phase.

      Result

      Section not applicable

      Conclusion

      Section not applicable

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