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S. Popat

Moderator of

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    Next generation TKI: Frontline or later? (ID 22)

    • Event: ELCC 2018
    • Type: Controversy session
    • Track:
    • Presentations: 4
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      Frontline (ID 90)

      09:15 - 10:15  |  Presenting Author(s): R. Califano

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      Introduction and first vote (ID 89)

      09:15 - 10:15  |  Presenting Author(s): S. Ramalingam, S. Popat

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      Later (ID 91)

      09:15 - 10:15  |  Presenting Author(s): E. Smit

      • Abstract
      • Presentation
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      Abstract not provided

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      Second vote and conclusions (ID 92)

      09:15 - 10:15  |  Presenting Author(s): S. Ramalingam, S. Popat

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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Author of

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    Developments in pharmacology for systemic therapy (ID 11)

    • Event: ELCC 2018
    • Type: Specialty session
    • Track:
    • Presentations: 1
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      Pharmacokinetics and interaction for TKI treatment (ID 43)

      11:00 - 12:30  |  Presenting Author(s): S. Popat

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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    Epidemiology and outcomes (ID 57)

    • Event: ELCC 2018
    • Type: Poster Discussion session
    • Track:
    • Presentations: 1
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      216PD - Should radical surgery be performed in non-epithelioid malignant pleural mesothelioma? (ID 508)

      14:45 - 15:45  |  Author(s): S. Popat

      • Abstract
      • Slides

      Background:
      Non-epithelioid malignant pleural mesothelioma (MPM) has a bad prognosis. We wished to evaluate the impact of multimodality therapy on survival in non-epithelioid MPM.

      Methods:
      Analysis of a prospective database of MPM patients operated on since September 2004. All patients had extended pleurectomy/decortication (ePD) and hyperthermic povidone-iodine pleural lavage (HPL), prophylactic radiotherapy and systemic platinum-based chemotherapy. All patients were followed up until death. PET–CT was used routinely to monitor patients. Survival and prognostic factors were analysed by the Kaplan–Meier method, log–rank test and Cox regression analysis.

      Results:
      139 patients had ePD and HPL. Median age was 64 years and 80% of patients were male.17% of patients had received systemic chemotherapy prior to surgery. 90–day mortality was nil and 39.6% of patients experienced postoperative complications. 9 patients had reoperation within 30 days. Final histopathology showed epithelioid type in 96 patients and non–epithelioid type in 43. Staging (8th ed. TNM classification) was as follows: I, 7.2%; II, 24.4%, III, 54%, IV, 14.4%. Five patients did not receive adjuvant chemotherapy and 4 received less than 4 cycles in total. All other patients received 4–6 cycles of chemotherapy. All patients received prophylactic radiotherapy (21 Gy). 52% of patients received second–line therapies. Two patients had cyberknife therapy and 3 patients had late reoperations for focal relapse. Median follow–up is 50 months and 92 patients have died. Median overall survival is 35 months (95% CI 26.3–43.7) for epithelioid histology versus 18 months (95% CI 15.1–20.9) for non-epithelioid histology (p = 0.000037). Macroscopic complete resection and epithelioid histology are independent prognostic factors of long–term survival at multivariate analysis.

      Conclusions:
      Multimodality therapy including ePD and HPL is safe and well-tolerated. Most patients can receive further therapies when disease progresses. Patients with epithelioid histology achieve prolonged survival. Patients with non-epithelioid histology have a modest survival benefit and radical surgery should be offered only to those with early-stage disease.

      Clinical trial identification:


      Legal entity responsible for the study:
      Dr. Loic Lang-Lazdunski

      Funding:
      Has not received any funding

      Disclosure:
      All authors have declared no conflicts of interest.

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    How can we optimise our organisation to deliver precision oncology? (ID 18)

    • Event: ELCC 2018
    • Type: Educational session
    • Track:
    • Presentations: 1
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      Organisational models for biomarkers testing (ID 73)

      16:45 - 18:15  |  Presenting Author(s): S. Popat

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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    Immunotherapy and next-generation TKIs: From second to frontline treatment (ID 55)

    • Event: ELCC 2018
    • Type: Poster Discussion session
    • Track:
    • Presentations: 1
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      143PD - Competing central nervous system or systemic progression analysis for patients with EGFR mutation-positive NSCLC receiving afatinib in LUX-Lung 3, 6, and 7 (ID 561)

      07:45 - 09:00  |  Author(s): S. Popat

      • Abstract
      • Slides

      Background:
      CNS metastases are known complications of advanced EGFRm+ NSCLC, thus, LUX-Lung (LL) trials investigating afatinib allowed enrolment of patients (pts) with brain metastases (BM). LL3, 6 and 7 previously demonstrated activity of afatinib in pts with BM, with the magnitude of progression-free survival (PFS) improvement with afatinib vs chemotherapy or gefitinib in pts with BM being similar to that observed in pts without BM (HR 0.54, 0.47, and 0.76 in LL3, 6 and 7, respectively).[1,2] PFS was significantly improved with afatinib vs chemotherapy in a combined analysis of LL3 and 6 in pts with asymptomatic BM (HR 0.50, p = 0.0297).[1] To investigate whether afatinib can prevent CNS progression or metastasis, competing risk analyses for the progression and metastasis pattern in the CNS or non-CNS region were carried out in pts with and without BM in LL3, 6 and 7.

      Methods:
      Competing risk analyses were performed in pts with stage IIIB/IV EGFRm+ NSCLC who received afatinib 40 mg/d in LL3, 6 and 7. Analyses were performed separately for pts with baseline BM and without baseline BM. Risk of CNS progression vs non-CNS progression or death was calculated based on the cumulative frequency of the event of interest vs the competing risk event.

      Results:
      In pts with baseline BM receiving afatinib in LL3 and 6 (n = 48; median follow-up 10.3 mo), 31.3% had CNS progression vs 52.1% with non-CNS progression: cumulative incidence at 6 and 12 mo (CNS vs non-CNS) was 15.5% vs 17.7%, and 24.5% vs 24.4%, respectively. In pts without baseline BM receiving afatinib in LL3, 6 and 7 (n = 485; median follow-up 13.0 mo), risk of de novo CNS progression was very low (6.4%) compared with non-CNS progression (78.4%). Cumulative incidence at 6 and 12 mo (CNS vs non-CNS) was 1.3% vs 17.2%, and 2.6% vs 41.2%, respectively.

      Conclusions:
      Competing risk analyses using data from LL3, 6 and 7 add to the existing evidence that support afatinib use in pts with EGFRm+ NSCLC and CNS metastases. Taken together, these results suggest afatinib delays the onset/progression of BM. 1. Schuler. J Thorac Oncol 2016;11:380–90 2. Park. Lancet Oncol 2016;17: 577–89

      Clinical trial identification:
      NCT00949650, NCT01121393, NCT01466660

      Legal entity responsible for the study:
      Boehringer Ingelheim

      Funding:
      Boehringer Ingelheim

      Disclosure:
      J.C-H. Yang: Honoraria/advisory board: Boehringer Ingelheim, Eli Lilly, Bayer, Roche/Genentech/Chugai, Astellas, MSD, Merck Serono, Pfizer, Novartis, Clovis Oncology, Celgene, Merrimack, Yuhan Pharma, BMS, Ono Pharma Daiichi Sankyo, Astrazeneca. Y-L. Wu: Honoraria: AstraZeneca, Roche, Eli Lilly, Pfizer, Sanofi. V. Hirsh: Advisory Board: BI. K. O'Byrne: Advisory board & Honoraria: Astrazeneca, BMS, Roche-Genentech, MSD, Pfizer, Boehringer-Ingelheim, Novartis Speaker bureau activities: Astrazeneca, BMS, Roche-Genentech, MSD, Pfizer, Boehringer-Ingelheim Travel to international conferences: Astrazeneca, BMS, Roche-Genentech, MSD, Pfizer, Boehringer-Ingelheim 3 patents –1 on novel drugs and 2 on biomarkers – IP held by University. N. Yamamoto: Membership on an advisory board or board of directors: BI, AZ, Chugai Corporate-sponsored research: BI. S. Popat: Membership on an advisory board or board of directors: BI. A. Tamiya: Grants from Ono Pharmaceutical, Bristol-Myers Squibb Received personal fees from Eli Lilly, Ono Pharmaceutical, Chugai Pharmaceutical, Boehringer Ingelheim, AstraZeneca, Bristol-Myers Squibb. A. Märten: Employment Boehringer Ingelheim. M. Schuler: Employment: Universität Duisburg-Essen, Universitätsklinikum Essen, Ruhrlandklinik Consultant (compensated): AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Novartis, Roche Consultant (not compensated): Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) Honoraries (CME presentations): Abbvie, Alexion, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Lilly, MSD, Novartis Research funding (institution) Boehringer Ingelheim, Bristol Myers-Squibb, Novartis Pantent: Universität Duisburg-Essen.

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    New approaches in rare thoracic tumors (ID 60)

    • Event: ELCC 2018
    • Type: Proffered Paper session
    • Track:
    • Presentations: 1
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      213O - Nintedanib + pemetrexed/cisplatin in malignant pleural mesothelioma (MPM): Phase II biomarker data from the LUME Meso study (ID 206)

      11:00 - 12:30  |  Author(s): S. Popat

      • Abstract
      • Presentation
      • Slides

      Background:
      The randomised Phase II/III LUME-Meso study is evaluating nintedanib + pemetrexed/cisplatin versus placebo + pemetrexed/cisplatin (≤6 cycles), followed by nintedanib or placebo maintenance, in chemo-naïve MPM. In the Phase II part, nintedanib treatment led to improved progression-free survival (PFS; hazard ratio [HR] = 0.54; p = 0.010) and a trend for longer overall survival (OS; HR = 0.77; p = 0.319) compared with placebo. Patients with epithelioid tumours derived greatest benefit. Plasma angiogenic factors and genomic markers were explored for potential associations with treatment outcome in the Phase II epithelioid population.

      Methods:
      Baseline plasma levels of 58 angiogenic factors were analysed by multiplex immunoassay (Human AngiogenesisMAP®, Myriad RBM). Genes implicated in the nintedanib mode of action and/or mesothelioma pathophysiology (VEGFR1, VEGFR3 and mesothelin) were evaluated for known single-nucleotide polymorphisms (SNPs). Biomarker associations with PFS/OS treatment effects were analysed by Cox regression and interaction tests with false-discovery rate (FDR) adjustment. Analyses were exploratory and hypothesis generating.

      Results:
      Angiogenic factor and genomic data were available for 71 and 67 patients, respectively, in the epithelioid population (n = 77). Of the angiogenic factors evaluated, only endoglin showed a possible trend for association with both PFS and OS improvement, with potentially greater benefit in patients with low plasma levels. Major homozygous genotypes for two VEGFR3 SNPs (rs307821 G/G and rs307826 A/A) showed weak association with OS effect, while the VEGFR1 SNP rs9582036 A/A genotype was potentially correlated with PFS benefit. However, all biomarker treatment associations were limited by small subgroup size (especially for minor genotypes) and FDR-adjusted interaction tests were not significant.

      Conclusions:
      These first biomarker results for nintedanib-treated MPM showed potential signals for greater PFS/OS benefits in patients with low plasma endoglin and major homozygous VEGFR1/3 genotypes, but no biomarkers showed clear and significant association with nintedanib efficacy.

      Clinical trial identification:
      NCT01907100

      Legal entity responsible for the study:
      Boehringer Ingelheim

      Funding:
      Boehringer Ingelheim

      Disclosure:
      N. Pavlakis: Advisory Boards: Boehringer Ingelheim, MSD, Merck, BMS, Astra Zeneca, Takeda, Bayer, Novartis, Pfizer, Roche, Ipsen Speaking Honoraria: Boehringer Ingelheim, Bayer, Novartis, Pfizer, Roche Travel Support: BMS, Astra Zeneca, Roche. N. Steele: Honoraria: Pfizer, Novartis Consulting/advisory role: MSD, Boehringer Ingelheim, BMS Research funding: Merck Serono, AstraZeneca, Boehringer Ingelheim, BMS, Novartis, Roche Travel, accommodation, expenses: Pfizer, MSD Oncology, Boehringer Ingelheim. A. Nowak: Consulting/ Advisory Role: Aduro Biotech, Morphotek, Bayer, AstraZeneca, Sellas Life Sciences, Trizell, Boehringer Ingelheim, Epizyme, Roche Research Funding: Boehringer Ingelheim, AstraZeneca Travel and expenses: Amgen, AstraZeneca, Boehringer Ingelheim. S. Novello: Speakers’ Bureau: AstraZeneca, MSD, Bristol-Myers Squibb, Roche, Pfizer, Eli Lilly. S. Popat: Honoraria: Pfizer, Boehringer Ingelheim, Eli Lilly, AstraZeneca, Novartis, Roche Consulting/advisory role: Boehringer Ingelheim, Eli Lilly, Pfizer, Novartis, Roche Research funding: Boehringer Ingelheim, Epizyme, BMS, Clovis Oncology, Eli Lilly, Roche. L. Greillier: Honoraria: Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Pfizer, AstraZeneca, Novartis Pharma, Roche Consulting/advisory role: Boehringer Ingelheim, Bristol-Myers Squibb, Roche Research funding: Roche. M. Reck: Honoraria: Boehringer Ingelheim, Proacta, BMS, MSD, Pfizer, Eli Lilly, AstraZeneca, Merck Inc., Celgene, Novartis Consulting/advisory role: Boehringer Ingelheim, Eli Lilly, BMS, MSD, Pfizer, AstraZeneca, Merck Inc., Celgene, Novartis, Roche Speaker's bureau: Roche, Eli Lilly, MSD Oncology, Merck, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Pfizer, Novartis. T. Kitzing: Employment: Boehringer Ingelheim. G. Scagliotti: Honoraria: Eli Lilly, Pfizer, MSD, AstraZeneca, Roche Consulting/Advisory role: Eli Lilly Speakers’ Bureau: Eli Lilly, MSD. All other authors have declared no conflicts of interest.

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    Next generation TKI: Frontline or later? (ID 22)

    • Event: ELCC 2018
    • Type: Controversy session
    • Track:
    • Presentations: 2
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      Introduction and first vote (ID 89)

      09:15 - 10:15  |  Presenting Author(s): S. Popat

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      Second vote and conclusions (ID 92)

      09:15 - 10:15  |  Presenting Author(s): S. Popat

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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    Poster Display session (Friday) (ID 65)

    • Event: ELCC 2018
    • Type: Poster Display session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/13/2018, 12:30 - 13:00, Hall 1
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      149P - Real-world outcomes with first-line afatinib in EGFR mutant NSCLC adenocarcinoma: A single centre experience exploring effects of dose-reduction (ID 274)

      12:30 - 13:00  |  Author(s): S. Popat

      • Abstract
      • Slides

      Background:
      Tyrosine kinase inhibitors of epidermal growth factor receptor (EGFR-TKI) are indicated for first-line treatment of EGFR+ advanced/metastatic NSCLC, having demonstrated superior progression free survival (PFS) and tolerability over chemotherapy in this setting. Afatinib is the only EGFR-TKI to have also shown superior overall survival (OS) over chemotherapy in patients with EGFR 19del mutations, albeit with higher toxicity: 53% and 28% dose reductions (DR) were reported in LUX-LUNG 3 (LL3) and LUX-LUNG 6 (LL6) trials, respectively. Effects of toxicities on treatment delivery and efficacy in the real-world UK population are unknown.

      Methods:
      Retrospective review of outcomes in patients with EGFR+ treatment naïve advanced/metastatic NSCLC treated with afatinib at a single UK centre. Primary endpoint: PFS. Key secondary endpoints: rate of DR; relative dose intensity; toxicities; objective response rate (ORR); PFS according to DR vs no DR; OS overall, by DR vs. no DR, and by mutation type. Survival analyses were performed using Kaplan-Meier methods and compared using the log-rank test.Table:Patient demographics and baseline characteristics (n = 44)

      Patient demographics and baseline characteristic (n = 44)No. (%)
      Age (median, range)63.5 (31–85)
      Gender
       M19 (43.2)
       F25 (56.8)
      Ethnicity
       Caucasian29 (65.9)
       Asian11 (25)
       Other4 (9.1)
      Stage at diagnosis
      2 (4.5)
       IIIA3 (6.8)
       IIIB1 (2.3)
       IV38 (86.4)
      ECOG performance status at start of afatinib
       09 (20.5)
       129 (65.9)
       26 (13.6)
      Comorbidities
       None18 (40.9)
       Mild23 (52.3)
       Moderate3 (6.8)
      EGFR mutation
       Exon 19 del29 (65.9)
       L858R11 (25.0)
       G719X2 (4.5)
       S768I1 (2.3)
       Exon 20 ins1 (2.3)
      Starting dose of afatinib
       40 mg40 (90.9)
       30 mg4 (9.1)


      Results:
      44 patients received first-line afatinib (30–40 mg) between September 2012 and July 2017. Patient characteristics are shown in the Table. 70% patients had at least one DR, 29% during the first cycle. Relative dose intensity was 77.1%. The most common toxicity was diarrhoea (32%), followed by skin rash (22%) and paronychia (18%). Out of 42 evaluable patients, 74% achieved partial response (56% and 67% in LL3 and LL6, respectively). Disease control rate was 93% (LL3: 90%, LL6: 93%). After median follow-up of 26 months, 27/42 patients had disease progression or death on afatinib, 10 patients remained on afatinib and 5 switched to other EGFR-TKI due to intolerable toxicities. mPFS was 12.3mo (LL3: 11.1mo, LL6: 11mo). mPFS in patients with a DR was 22.7mo vs. 12.3mo if no DR (HR 0.69, p = 0.38). Median OS was 31.4mo (LL3: 28.2mo, LL6: 23.1mo). There was no significant difference in mOS for patients with DR vs. no DR (31.4 vs 24.4mo, HR 1.51, p = 0.46). There was a trend towards greater OS for patients with EGFR del19, but not statistically significant (p = 0.23). EGFR T790M testing was available for 19 patients after progression on afatinib, with 6 positive for T790M, all of whom went on to a third-generation EGFR-TKI.

      Conclusions:
      Dose reductions on afatinib are required in a majority of real-world patients, with no significant detrimental impact on efficacy and long-term survival outcomes which, in our cohort, were consistent with trial data.

      Clinical trial identification:


      Legal entity responsible for the study:
      Royal Marsden Hospital

      Funding:
      Has not received any funding

      Disclosure:
      M. O'Brien: Advisory work for BI. J. Bhosle: Honoraria from Boehringer Ingelheim. S. Popat: Consulting/advisory for Boehringer Ingelheim. All other authors have declared no conflicts of interest.

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