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Florian Guisier



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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: 2
    • 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): Florian Guisier

      • 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

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      P1.04-35 - Quick Progression (QP) in Patients Treated by Nivolumab (IO) in 2nd Line or More for Non-Small Cell Lung Cancer: ERORECI Study (GFPC 2016-04) (ID 11936)

      16:45 - 18:00  |  Author(s): Florian Guisier

      • Abstract
      • Slides

      Background

      Nivolumab has been approved in 2nd line for advanced non-small cell lung cancer (NSCLC). However, more than half of the patients had progressive disease at 16 weeks, without any response and sometimes with deleterious progressions. This descriptive prospective study aimed to assess the characteristics of non responders with QP after IO and the following treatments.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      From September 1st, 2016 to August 31th, 2017, patients (pts) treated by IO (second line or more) with QP<16 weeks were included by 20 GFPC centers. NSCLC characteristics at the diagnosis, at the IO initiation, treatments (before IO, IO and after IO) and outcomes responses, progression free survival (PFS) according to lines of treatments were recorded.

      4c3880bb027f159e801041b1021e88e8 Result

      The sample included 319 pts: 64,3y± 9,6, smokers/ex-smokers: 48.0%-42.9%, male: 70.8%, PS01/2: 92.8%-7.2%, stage IV at diagnosis: 71.8%; adenocarcinoma: 63.9%. K-Ras mutated: 25.7%. Only 29% of patients had a PDL1 determination. 93% of pts received first line therapy, 32% second line, 10.3% third line before IO. First line PFS (PFS1) was 6.9m [6.43-7.8], PFS2: 9.33m [1.2-19], PFS3: 4.1m [1.56-12.43]. PFS for IO was 1.7m [0.76-4.16]. 229 (71,8%) patients had a IO PFS<2m; 14.7% of these patients stopped the treatment for toxicity. Among the 146 pts evaluable for response, PR was found in 23% of cases, SD in 30%, and PD in 47%.The table describe a comparison between two groups of QP during IO.

      table eroreci.jpg

      8eea62084ca7e541d918e823422bd82e Conclusion

      In real life, QP during IO remains a challenge in NSCLC. Multivariate analyses will be presented to characterize these patients.

      _______________________________________________________________________________________________________________

      In collaboration with the GFPC* team and supported by an academic grant from Pierre-Fabre pharmaceuticals.

      *GFPC: French Lung Cancer Group

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    P1.09 - Pathology (Not CME Accredited Session) (ID 941)

    • 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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      P1.09-02 - PD-L1 Expression Pattern in Large Cell Neuroendocrine Carcinoma of the Lung: The GFPC 03-2017 "EPNEC" Study. (ID 11945)

      16:45 - 18:00  |  Author(s): Florian Guisier

      • Abstract
      • Slides

      Background

      Large cell neuroendocrine carcinomas of the lung (LCNECs) are rare neoplasms with few therapeutics options especially for stage IV diseases. Pathological diagnostic of LCNECs may be difficult with low interobserver reproducibility and need immunohistochemical (IHC) staining. Immune checkpoint inhibitors targeting tumoral and immune cells interaction have revolutionized the treatment of NSCLC, but few data's are available on LCNECs immune environment and particulary the expression of PD-L1 on both tumors (TC) and immune infiltrating (IC) cells. The objective of the present study is to determine the pattern of PD-L1 staining in a cohort of LCNECs patients.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Clinical files and tumors biopsies of patients (pts) with a LCNEC diagnosed between 01.01.2014 and 31.12.2016 were retrospectively collected (GFPC 03-2017). All histological samples were centrally reviewed by a panel of six independent pathologists, according to the WHO 2015 classification. LCNEC was confirmed and PD-L1 expression was determined both in TC and IC, using the anti-PD-L1 antibody 22C3 (kit and automat Dako). PD-L1 expression was scored on TC as the percentage of PD-L1 positive cells (0 to 100%). PD-L1 expression on IC was determined as follows: IC0: positive IC representing<1% of the tumor surface; IC1: positive IC representing>=1% but<5% of the tumor surface; IC2: positive IC representing>=5% but<10% of the tumor surface; and IC3: positive IC representing>10% of the tumor surface.

      4c3880bb027f159e801041b1021e88e8 Result

      Eighty-six pts were initially included in the study.Twenty-eight (32%) of them were excluded for non-LCNEC diagnosis after review. Among the 58 remaining pts with confirmed LCNEC, five (8%) had a mixed histology with a NSCLC component.The mean age of the population was 65 years, mainly mens (86%) and former or current heavy smokers (93%). Fifty-five and 51 tumors samples were respectively available for TC and IC PD-L1 IHC expression. PD-L1 expression on TC was found in only 12% of the samples (7/55), while 76% (39/51) of the samples shows IC PD-L1 positive, with respectively 18 (35%) IC3, 8 (14%) IC 2, and 13 (25%) IC1.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Histological diagnosis of LCNEC remains difficult, and prospective studies concerning patients with LCNEC should include a centrally pathological review of tumors.The PD-L1 expression pattern looks different for LCNEC in comparison to other lung carcinomas, as few TC were found positive although IC were frequently positive, half of the tumors having high PD-L1 IC infiltration (IC3/2). This PD-L1 pattern may suggest a potential effectiveness of therapeutic anti PD-L1 antibodies and this hypothesis have to be adressed in clinical trials.

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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): Florian Guisier

      • 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

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