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Joop de Langen



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    GR02 - Management of N2 NSCLC - A Case Based Discussion (ID 778)

    • Event: WCLC 2018
    • Type: Grand Rounds Session
    • Track: Treatment of Locoregional Disease - NSCLC
    • Presentations: 3
    • Moderators:
    • Coordinates: 9/25/2018, 15:15 - 16:45, Room 107
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      GR02.02 - Panel Discussion (ID 11394)

      15:25 - 15:45  |  Presenting Author(s): Joop de Langen

      • Abstract

      Abstract not provided

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      GR02.04 - Panel Discussion (ID 14533)

      15:55 - 16:15  |  Presenting Author(s): Joop de Langen

      • Abstract

      Abstract not provided

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      GR02.06 - Panel Discussion (ID 14534)

      16:25 - 16:45  |  Presenting Author(s): Joop de Langen

      • Abstract

      Abstract not provided

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    MA26 - New Therapies and Emerging Data in ALK, EGFR and ROS1 (ID 930)

    • Event: WCLC 2018
    • Type: Mini Oral Abstract Session
    • Track: Targeted Therapy
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/26/2018, 13:30 - 15:00, Room 201 BD
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      MA26.06 - Crizotinib-Treated ALK Immunopositive Metastasized NSCLC is Associated with an Unfavorable Prognosis when FISH Negative  (ID 13179)

      14:05 - 14:10  |  Author(s): Joop de Langen

      • Abstract
      • Presentation
      • Slides

      Background

      Metastasized NSCLC with an ALK fusion are sensitive to a range of tyrosine kinase inhibitors. ALK-positive NSCLC has been identified in the pivotal phase III trial with fluorescence in situ hybridization (ALK FISH+). These tumors are also expressing the fusion product (ALK immunohistochemistry (IHC)+). However, discrepant cases occur, including ALK IHC+ FISH-. The aim of this study was to collect ALK IHC+ cases and compare within this group response to crizotinib treatment of ALK FISH+ cases with ALK FISH- cases.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      A prospective multicenter investigator initiated research study was started in Europe. Stage IV ALK IHC+ NSCLC cases treated with crizotinib were collected centrally. Slides were validated centrally for ALK IHC (with 5A4 ETOP and D5F3 Ventana protocol) and ALK FISH (Vysis probes).

      4c3880bb027f159e801041b1021e88e8 Result

      The study started April 1, 2014 and closed in November 2017. Fifteen centers participated. Registration of 3523 ALK IHC tests revealed prevalence of 2.6% ALK IHC+ cases. Local ALK FISH analysis resulted in 46 concordant (ALK IHC+/FISH+) and 18 discordant (ALK IHC+/FISH-) cases. Central validation revealed 37 concordant and 6 discordant cases, 5 of which had follow-up. Validation was hampered by limited amount of tissue in biopsy samples. The time to treatment failure did not differ for concordant nor discordant cases, and neither for local nor validated ALK testing (HR=0.78; 95% CI= 0.27-2.3; p=0.64) and (HR=2.2; 95% CI= 0.72-6.5; p=0.16), respectively). However, overall survival was significantly better for concordant cases than discordant cases after central validation (HR=4.5; 95% CI= 1.2-15.9; p=0.010), but not according to local testing (HR=1.7; 95% CI= 0.45-6.2; p=0.44).

      8eea62084ca7e541d918e823422bd82e Conclusion

      ALK IHC+ FISH- NSCLC cases are an infrequent finding. We recommend such cases to be validated carefully because our data indicate that ALK IHC+ FISH- cases have a worse survival when treated by crizotinib compared to ALK IHC+ FISH+ cases.

      This study was funded by an independent research grant by Pfizer

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    P2.13 - Targeted Therapy (Not CME Accredited Session) (ID 962)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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      P2.13-42 - Osimertinib Treatment for Patients with EGFR exon 20 Insertion Positive Non-Small-Cell Lung Cancer (ID 14152)

      16:45 - 18:00  |  Presenting Author(s): Joop de Langen

      • Abstract

      Background

      Epidermal growth factor receptor (EGFR) exon 20 insertions are identified in 4-10% of al EGFR mutations in non-small cell lung cancer (NSCLC) and are generally associated with primary resistance to first and second generation EGFR tyrosine kinase inhibitors (TKIs). In vitro and preclinical animal studies have shown that osimertinib exerts antitumor activity in EGFR exon 20 insertion positive NSCLC cell lines. We report on a cohort of advanced stage NSCLC patients, harboring an EGFR exon 20 insertion, that was treated with osimertinib.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      17 patients with advanced NSCLC harboring an EGFR exon 20 insertion were treated with osimertinib 80 mg once daily, in four institutions in the Netherlands. Data were obtained retrospectively. EGFR mutation status was assessed by next-generation sequencing. Progression free survival (PFS), disease control rate (DCR) and objective response rate (ORR) were assessed using RECIST v1.1.

      4c3880bb027f159e801041b1021e88e8 Result

      Median age was 63 years (range 35 – 81), 71% was female and median number of prior systemic treatments was 1 (range 0 – 3). Ten patients (59%) received prior platinum-based chemotherapy, and 2 patients afatinib, one patient experienced stable disease for 11 months, the other patient showed progression. Among all patients treated with osimertinib, we observed 1 partial response, 13 patients with stable diseases and 3 with progressive disease as best response (ORR 6%). Two patients were still on osimertinib treatment at the cut-off date. Median PFS was 3.7 months (95% CI: 2.3 – 5.4 months). Six of seventeen patients (35%) achieved DCR at five months.

      Patient

      Number of prior treatments

      Prior platinum based chemotherapy

      Prior EGFR TKI

      Best RECIST response

      PFS (months)

      1

      2

      Yes

      no

      SD

      4.0

      2

      1

      Yes

      no

      SD

      1.6

      3

      2

      Yes

      no

      PR

      0.7

      4

      1

      Yes

      no

      PR

      0.7

      5

      2

      Yes

      no

      SD

      3.8

      6

      1

      Yes

      no

      SD

      3.0

      7

      3

      Yes

      no

      SD

      9.3

      8

      1

      Yes

      no

      SD

      17.0

      9

      1

      No

      no

      SD

      3.7

      10

      1

      Yes

      no

      SD

      17.2

      11

      0

      No

      no

      PR

      3.1

      12

      0

      No

      no

      SD

      2.6

      13

      0

      No

      no

      SD

      6.5

      14

      3

      Yes

      afatinib (SD)

      SD

      7.9

      15

      1

      No

      afatinib (PD)

      PD

      1.7

      16

      0

      no

      no

      SD

      8.3

      17

      0

      no

      no

      SD

      1.4

      EGFR, epidermal growth factor receptor; RECIST: Response Evaluation Criteria in Solid Tumors; PR, partial response; SD, stable disease; PD, progressive disease; PFS, progression free survival

      8eea62084ca7e541d918e823422bd82e Conclusion

      Osimertinib has limited antitumor activity in patients with EGFR exon 20 mutated NSCLC, with an ORR of 6%. A subset of patients (35%) seems to derive benefit from osimertinib treatment with durable disease control for more than five months.

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