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Helene Doubre



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    P1.04 - Immunooncology (Not CME Accredited Session) (ID 936)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.04-31 - Efficacy and Tolerance of Immune-Checkpoint Inhibitors in EGFR, ALK/ROS 1 Non-Small-Cell-Lung-Cancer (NSCLC): GFPC 03-2016 IMAD Study (ID 11166)

      16:45 - 18:00  |  Author(s): Helene Doubre

      • Abstract
      • Slides

      Background

      Patients with molecular alterations are considered to be poor candidates for immune- checkpoint inhibitors (ICI) on the second-line phase III trials. Here, we analyze the efficacy of ICI in EGFR /ALK/ROS1 NSCLC patients in real world setting

      a9ded1e5ce5d75814730bb4caaf49419 Method

      This retrospective, multicentric study in EGFR, ALK and ROS1 NSCLC treated by ICI, analyzed clinical characteristics and outcomes (progression free survival (PFS), duration of ICI treatment and overall survival (OS), since initiation of ICI .

      4c3880bb027f159e801041b1021e88e8 Result

      51 patients were included from 20 centers in France: 100% adenocarcinoma, 60.7% never smokers, 58.8% female, 58 ± 8.8 years age at diagnosis (36-83), 82.3% EGFR mutated, 15.7 % and 2% ALK and ROS 1 translocated respectively. ICI was a third line treatment in 35,3% of cases, a fourth and more lines treatment in 64,7% of cases. Median PFS was 2.1. [95% CI: 1.5-3.2] months for the whole population, 2.15 [95% CI: 1.4-3;2], for EGFR patients and 2.4 [95% CI: 2.1; NR] for ALK tranlocated patients; 3 months-PFS were 37,3% [95% CI: 26.1; 53.2]; 8 weeks ORR were 19.6% (10 pts with partial response). The median OS for the whole population was 14.7.[95%CI: 12.1-19.2] months, 13.9 [95% CI: 8.8-20] for EGFR patients, 19.2. [95% CI: 13.1-NR] for ALK translocated; 7 (13.7%) patients were treated more than 9 months by ICI; 21.6% (11/51) of patients reported toxicities, all < grade3.

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      8eea62084ca7e541d918e823422bd82e Conclusion

      In this real-world setting analysis, efficacy of ICI in EGFR, ALK, ROS1 NSCLC patients appears close to the efficacy observed in pretreated unselected NSCLC patients. Large prospective studies are needed in these populations

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    P1.13 - Targeted Therapy (Not CME Accredited Session) (ID 945)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.13-09 - Efficacy and Tolerance of Osimertinib in Real Word Setting: Results of the French Early Access Program (EXPLORE T790M GFPC Study). (ID 11335)

      16:45 - 18:00  |  Author(s): Helene Doubre

      • Abstract
      • Slides

      Background

      Based on the Phase III AURA3 trial, osimertinib a third-generation EGFR TKI is approved in France in EGFR T790M-positive advanced NSCLC whose disease have progressed on or after first or second generation EGFR TKI.

      Objective: to assess efficacy and tolerance of Osimertinib in real world setting.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Retrospective, multicentric study including T790M-positive advanced NSCLC receiving osimertinib from 07 April 2015 to 27 April 2016 in French early access program. Overall survival (OS) and progression free survival PFS) were analyzed in the whole population, in the subgroup of patients with cerebral metastasis at osimertinib initiation and according to the number of previous treatment lines (1 versus 2 or more).

      4c3880bb027f159e801041b1021e88e8 Result

      The analysis included 205 patients treated in 52 centers; mean age 69.5 ± 11.1 years, female 68.8%, adenocarcinoma 97.5%, EGFR mutations exons 19/21: 66.5%/ 30.5%, never smokers 71.5 %, PS 0-1/2/ 3-4: 54%/18,8%/27.2%, stage IV: 87.4%,presence of cerebral metastasis at osimertinib initiation: 43.7% .

      EGFR T790M mutation diagnosis have been done by liquid biopsy in 34.4 % or on tissue re-biopsy in 65.6%. Patients received a median of 2.8 ± 1.5 lines of treatment before osimertinib initiation. All patients received a first or second generation EGFR TKI before osimertinib. Osimertinib has been used in second line setting in 18% of cases and in third line or more setting in 82%.

      Median PFS was 12.4 (CI 95%: 10.1-15.1) months in the whole population, 9.7 (CI 95%: 7.7-13.5) in patients with cerebral metastasis and 15.8 (CI 95%: 11.9-17) months in patients without cerebral metastasis, (p : 0.2). PFS was not significantly different according to the use of osimertinib as second or third line of treatment: 12.6 (CI 95%: 6.7-17.5) vs 12.4 (CI 95%: 9.7-15.3) months, respectively.

      Median OS since osimertinib initiation was 20.5 (CI 95%: 16.9-24.3) months, 23.06 [18.56;27.83] and 18.00 [12.16;22.21] months in patients without and with cerebral metastasis, respectively. OS was not significantly different according the use of osimertinib as second or third line of treatment: 17.5 (CI 95%: 11.6;27.8) vs 21.7 (CI 95%: 17.3;24.3) months (p=0.4).

      A new biopsy was performed at disease progression on osimertinib in 50 patients: data will be presented.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Efficacy of Osimertinib in real world setting appears similar to that observed in clinical trials in patients with EGFR T790M mutation in ≥2ndline.

      Clinical trial information: Supported by an academic grant from Astra Zeneca

      6f8b794f3246b0c1e1780bb4d4d5dc53

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