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Simon Ekman



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    ES03 - Understanding and Treating Oligometastatic Diseases (ID 161)

    • Event: WCLC 2020
    • Type: Educational Session
    • Track: Locoregional and Oligometastatic Disease
    • Presentations: 1
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      ES03.04 - Timing of Systemic Therapy in OMD (ID 3978)

      10:30 - 11:30  |  Presenting Author(s): Simon Ekman

      • Abstract
      • Presentation
      • Slides

      Abstract

      The optimal treatment sequence of systemic therapy and local ablative therapy (LAT) in non-small cell lung cancer is still unclear. An individualized assessment of every patient is necessary to develop a radical-intent treatment plan and the use of multidisciplinary teams is encouraged. There are several factors to consider for systemic therapy in the OMD setting, including extension of primary tumor, presence or absence of targetable mutations, number and location of metastases, synchronous vs. metachronous OMD, patient-related factors and previous systemic treatments. This presentation will explain the scientific evidence that exists for different treatment strategies integrating systemic therapy and LAT, including for oncogenic-driven tumors, chemotherapy and immunotherapy.

      References:

      Guckenberger et al. Lancet Oncol 2020; 21: e18–28

      Dingemans et al. Journal of Thoracic Oncology Vol. 14 No. 12: 2109-2119

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    P76 - Targeted Therapy - Clinically Focused - EGFR (ID 253)

    • Event: WCLC 2020
    • Type: Posters
    • Track: Targeted Therapy - Clinically Focused
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      P76.72 - A PET and MRI Study Exploring Osimertinib Brain Exposure and Efficacy in EGFRm NSCLC CNS Metastases (ID 3366)

      00:00 - 00:00  |  Presenting Author(s): Simon Ekman

      • Abstract
      • Slides

      Introduction

      Osimertinib is a third-generation, irreversible, oral EGFR-TKI that potently and selectively inhibits EGFR-TKI-sensitising and EGFR T790M-resistance mutations in NSCLC. CNS metastases (CNSm) are associated with poor prognosis in NSCLC. Preclinically, osimertinib has shown superior CNS exposure compared with other EGFR-TKIs in molecular imaging studies; radiolabelled osimertinib was shown to cross intact blood-brain barrier in healthy subjects. In FLAURA and AURA3 studies, osimertinib demonstrated efficacy in patients with EGFR-mutation positive (EGFRm) NSCLC and CNSm. ODIN-BM (NCT03463525) is a first-in-patient study that intends to build on previous data to confirm CNS exposure of [11C]osimertinib directly in patients.

      Methods

      This open-label, single-centre phase I study enrolled adult patients (aged 52–77 years) with EGFRm advanced NSCLC with CNSm. Patients could be EGFR-TKI-naïve or have progressed on prior EGFR-TKI, with confirmed EGFR T790M. Three PET examinations were performed following intravenous (IV) injection of a microdose (<10µg) of 11C-labelled osimertinib: at baseline before commencement of 80 mg daily osimertinib clinical treatment, then six hours after the first 80 mg daily dose, and again after 21 days’ daily treatment. Clinical efficacy was determined by CNSm size measured on contrast-enhanced T1 MRIs at baseline and Day 25–35. CNSm were delineated on MRI into tumour shell (mass) and total tumour including the core (volume). The primary objective was determination of [11C]osimertinib distribution in CNSm vs whole brain. Extracranial CT scans were assessed with RECIST 1.1 at baseline and the ~4 week follow-up visit.

      Results

      Four patients completed all imaging visits. PET examinations demonstrated rapid brain distribution of [11C]osimertinib in all patients at all three time points. Maximum concentrations in brain were achieved between 11–42 min after IV injection, with an exposure of 1.5%±0.1% of injected radioactivity. [11C]osimertinib volume of distribution was comparably high in CNSm and healthy brain tissue, despite heterogeneous presentation (numbers and sizes of lesions) between patients. MRI showed decreases in total CNSm mass (range: 53–96% reduction) and volume (range: 55–95% reduction) after 3–4 weeks’ treatment.

      Conclusion

      Rapid, high and widespread brain exposure of [11C]osimertinib was observed in healthy brain tissue and CNSm in all PET examinations, regardless of co-administration of 80 mg osimertinib. MRI showed marked reduction in CNSm mass and volume following 3–4 weeks’ treatment with daily osimertinib 80 mg. These early results support the efficacy and uniform brain penetration of osimertinib in patients with CNSm reported in previous clinical studies.figure_upload_v2.png

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