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    P09 - Health Services Research/Health Economics - Real World Outcomes (ID 121)

    • Event: WCLC 2020
    • Type: Posters
    • Track: Health Services Research/Health Economics
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      P09.61 - Epidemiological and Clinical Burden of EGFR Exon 20 Insertion in Advanced NSCLC: Results of a Systematic Literature Review (ID 1271)

      00:00 - 00:00  |  Author(s): Helena Emich

      • Abstract
      • Slides

      Introduction

      The burden of epidermal growth factor receptor (EGFR) exon 20 insertion (ex20Ins) mutation is not well understood. A systematic review was conducted to identify the available evidence on mutation frequency, prognostic impact, and clinical, patient-reported, and economic outcomes.

      Methods

      Prespecified PICOS criteria were used to determine study eligibility. MEDLINE, Embase (1974-September 2019), and conference proceedings (2018-2019) were searched. Studies were not limited by intervention, geography, or publication year and were stratified by line of therapy.

      Results

      Eighty-four unique studies were included; 53 reporting mutation frequency, 18 prognostic impact, 35 clinical outcomes, and one humanistic burden. No economic burden data were identified.

      The frequency of ex20Ins mutation ranged from 0.1% to 4% of all NSCLC cases and 1% to 12% of all EGFR mutations with a wide range of test methodologies observed (Table 1). Data on the prognostic impact of ex20Ins were heterogeneous but highlighted poorer treatment outcomes in ex20Ins compared with other EGFR mutations and EGFR wildtype across a wide range of therapies (chemotherapy, TKIs) and treatment lines.

      Seven clinical trials and 37 prospective observational studies reported clinical outcomes for patients with ex20Ins (Table 2). Trends towards better median PFS, OS, and ORR were observed for chemotherapy compared with TKIs as first-line treatments. For subsequent treatment lines, novel targeted therapies provided encouraging preliminary responses while results for chemotherapy were limited. Limited safety data were reported.

      One conference abstract described the symptom burden for ex20Ins patients with fatigue and pain being most common.

      Conclusion

      We found substantial global variations in the frequency of ex20Ins mutation detection. Across the clinical studies, ex20Ins had a worse prognosis compared to common EGFR mutations. Data on emerging ex20Ins targeted therapies are encouraging but limited. More research is needed to understand the humanistic and economic impact of ex20Ins.

      Table 1. The Range of Mutation Frequency Reported Across the Included Studies by Region

      Region

      Frequency of exon 20 ins (%)

      # Studies

      NSCLC

      # Studies

      EGFRm Positive NSCLC

      US

      9

      0.5-2.6%

      7

      5-12%

      Latin America

      7

      1.3-2.1%

      5

      5-8%

      Europe

      13

      0.3-1.3%

      10

      4-12%

      Asia Pacific

      28

      0.1-4.0%

      16

      1-5%

      China

      9

      0.3-2.9%

      7

      2-5%

      Japan

      4

      1.8-2.4%

      2

      2-5%

      Taiwan

      3

      1.3-4.0%

      2

      3-4%

      South

      5

      0.3-3.4%

      4

      1-4%

      South East

      4

      0.1-2.4%

      2

      2-3%

      Australia

      1

      1.4%

      0

      NA

      Table 2. Range of Ex20Ins Clinical Outcomes Across Included Studies: Mean OS and PFS (months) and ORR (%) by Line of Therapy and Treatment Type For Treatment Groups Including >10 Patients

      1L

      2L+

      Mixed LOT

      All Treatments

      mOS

      6.3-28
      [10 studies; 307 patients]

      8-17.1
      [6 studies; 129 patients]

      4.8-29.4
      [7 studies; 235 patients]

      mPFS

      1.8-6.9
      [11 studies; 354 patients

      1.9-7.3
      [10 studies; 215 patients]

      1.4-4.5
      [8 studies; 203 patients]

      ORR

      0-29%
      [7 studies; 250 patients]

      0-43%
      [12 studies; 374 patients]

      0-67%
      [9 studies; 218 patients]

      TKI

      mOS

      7.1-16.8
      [4 studies; 81 patients]

      12.9-15.3
      [2 studies; 47 patients]

      4.8-19
      [4 studies; 125 patients]

      mPFS

      1.8-6.4
      [6 studies; 116 patients]

      1.9-3.7
      [4 studies; 79 patients]

      1.4-3.1
      [7 studies; 206 patients]

      ORR

      6.3-8.7%
      [2 studies; 39 patients]

      0-43%
      [5 studies; 107 patients]

      0-36%
      [6 studies; 142 patients]

      Chemotherapy

      mOS

      15.9-28
      [4 studies; 259 patients]

      17.1
      [1 study; 17 patients]

      26-29.4
      [3 studies; 113 patients]

      mPFS

      3.4-6.9
      [5 studies; 238 patients]

      4.1-4.8
      [3 studies; 58 patients]

      4.5
      [1 study; 22 patients]

      ORR

      23-29%
      [4 studies; 211 patients]

      17-42%
      [2 studies; 24 patients]

      50-63%
      [3 studies; 79 patients]

      Ex20Ins Targeting Therapy

      mOS

      -

      -

      -

      mPFS

      -

      7.3
      [1 study; 28 patients]

      -

      ORR

      -

      14.8-43%
      [4 studies; 214 patients]

      -

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