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S. Novello

Moderator of

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    Second line in non-oncogene addiction (ID 8)

    • Event: ELCC 2018
    • Type: Educational session
    • Track:
    • Presentations: 4
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      Chemotherapy combined with antiangiogenics: Which patients and when? (ID 28)

      09:00 - 10:30  |  Presenting Author(s): M. Garassino

      • Abstract
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      Abstract not provided

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      Hyperprogressive disease in second-line (ID 30)

      09:00 - 10:30  |  Presenting Author(s): B. Besse

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      Immunotherapy: Which patients and when? (ID 29)

      09:00 - 10:30  |  Presenting Author(s): E. Garon

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      Abstract not provided

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      New promising strategies in second-line (ID 31)

      09:00 - 10:30  |  Presenting Author(s): J. Remon-Masip

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      • Presentation
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      Abstract not provided

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Author of

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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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      The patient’s point of view (ID 76)

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

      • Abstract
      • Presentation
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      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: 2
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      138PD_PR - Patient-reported outcomes (PROs) in ALEX: A phase III study of alectinib (ALEC) vs crizotinib (CRIZ) in non-small-cell lung cancer (NSCLC) (ID 464)

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

      • Abstract
      • Slides

      Background:
      ALEC showed superior efficacy versus CRIZ in patients (pts) with treatment-naïve ALK+ NSCLC in the phase III ALEX trial (NCT02075840). PRO data (disease burden, symptom tolerability and health-related quality of life [HRQoL]) are reported here.

      Methods:
      Pts (n = 303) were randomised 1:1 to receive ALEC (600 mg BID) or CRIZ (250 mg BID). Primary endpoint: investigator-assessed PFS. PROs were collected using EORTC QLQ-C30/QLQ-LC13 questionnaires. Pre-specified endpoints: time-to-deterioration (TTD) in lung cancer symptoms and HRQoL, longitudinal analyses of mean score changes from baseline, and proportion of pts with clinically meaningful change (≥10-point change from baseline) during treatment in the ITT population and patients with baseline CNS metastases.

      Results:
      Baseline completion rates and characteristics were balanced between arms in the PRO-evaluable population (ALEC n = 100, 65.8%; CRIZ n = 97, 64.2%). Median TTD in composite symptom endpoint (cough, dyspnoea, chest pain) was similar between arms (HR 1.10 [95% CI 0.72–1.68]). On average, ALEC pts reported a clinically meaningful improvement in baseline lung cancer symptoms for a longer duration of time versus CRIZ (cough, week 96 vs week 84; chest pain, week 96 vs week 80; fatigue, week 96 vs 68; pain in other parts, week 96 vs 68, respectively). Differences in lung symptoms between treatment arms tended to favour ALEC from 11.1 months (45 weeks), which was around the time of median PFS with CRIZ. ALEC pts reported a clinically meaningful improvement from baseline in HRQoL for a longer duration of time than CRIZ pts (week 88 vs 68, respectively). Fewer ALEC pts experienced a clinically meaningful worsening in treatment-related symptoms (nausea/vomiting, diarrhoea, appetite loss, dysphagia, peripheral neuropathy) than CRIZ pts.

      Conclusions:
      TTD for lung cancer symptoms was comparable between arms. Clinically meaningful improvement in lung cancer symptoms was maintained for longer with ALEC versus CRIZ, consistent with the improved PFS with ALEC versus CRIZ. HRQoL was improved with ALEC versus CRIZ. PRO data are consistent with ALEX safety data and confirm greater tolerability with ALEC versus CRIZ.

      Clinical trial identification:
      BO28984; 15 April 2016

      Legal entity responsible for the study:
      F. Hoffmann-La Roche Ltd

      Funding:
      F. Hoffmann-La Roche Ltd

      Disclosure:
      M. Perol: Advisory role for Roche and Pfizer. S. Peters: Education grants, provided consultation, attended advisory boards and/or provided lectures for the following organisations: Amgen, AstraZeneca, Boehringer-Ingelheim, Bristol-Myers Squibb, Clovis, Eli Lilly, F. Hoffmann-La Roche, Janssen, Merck Sharp and Dohme and Merck Serono, Pfizer, Regeneron and Takeda. N. Pavlakis: Advisory role for Novartis, Takeda, Roche and Pfizer. S. Novello: Speakers Bureau for: Eli Lilly, BMS, MSD, F. Hoffmann-La Roche Ltd and Astra Zeneca. T. Karagiannis: Employee of, owns stocks in and has taken part in company-sponsored research for Genentech. A. Zeaiter: Employee of F.Hoffman-La Roche Ltd. R. Dziadziuszko: Substantive relationships with Novartis, Pfizer and BMS. All other authors have declared no conflicts of interest.

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      139PD - Patient-reported outcomes from FLAURA: Osimertinib versus standard of care (SoC) epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) in patients with EGFR-mutated advanced non-small cell lung cancer (NSCLC) (ID 396)

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

      • Abstract
      • Slides

      Background:
      In the phase 3 FLAURA trial (N = 556), osimertinib demonstrated superior efficacy to SoC EGFR-TKI as first-line treatment of EGFR mutation-positive advanced NSCLC.[1]

      Methods:
      Patients in FLAURA completed the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items (QLQ-C30) at baseline and then every 6 weeks, and Lung Cancer 13 items (QLQ-LC13) at baseline, then weekly for 6 weeks followed by every 3 weeks. Scores range from 0 to 100; higher scores represent greater symptom burden. A ≥10-point difference is considered clinically relevant. Pre-specified key symptoms were cough, dyspnoea, chest pain, appetite loss and fatigue.

      Results:
      Compliance with completing the questionnaire was ≥60% at all time points in both treatment arms. Baseline mean scores were similar in the osimertinib and SoC arms for cough (32.8 vs 33.5), dyspnoea (22.5 vs 25.0), chest pain (19.5 vs 20.8), appetite loss (22.7 vs 25.6) and fatigue (32.2 vs 35.8). Key symptoms improved in both arms from baseline over the first 9 months, with no significant differences in least-squares mean changes between the osimertinib and SoC arm (Table). Improvements in cough were seen from week 1 and were maintained throughout the first 9 months in both arms. QLQ-C30 functional and global health/quality of life scores improved from baseline in both arms, with no clinically relevant differences. Additional analyses are ongoing, including statistical significance testing and time to deterioration.Table:Change from baseline over 9 months in key patient-reported symptoms

      SymptomTreatmentnAdjusted least-squares mean (95% CI)Estimated treatment difference (95% CI)
      CoughOsimertinib248–11.0 (–12.8, –9.2)0.7 (–1.9, 3.2)
      SoC252–11.7 (–13.5, –9.8)
      DyspnoeaOsimertinib248–4.0 (–5.6, –2.5)0.1 (–2.2, 2.4)
      SoC252–4.1 (–5.7, –2.5)
      Chest painOsimertinib248–6.6 (–8.2, –5.0)–0.2 (–2.5, 2.1)
      SoC252–6.4 (–8.0, –4.8)
      Appetite lossOsimertinib252–6.2 (–8.4, –3.9)–0.5 (–3.7, 2.7)
      SoC247–5.6 (–8.0, –3.3)
      FatigueOsimertinib252–5.5 (–7.5, –3.5)–0.8 (–3.6, 2.1)
      SoC247–4.7 (–6.7, –2.7)
      Adjusted mean and estimated treatment differences obtained from a mixed-effects model for repeated measures. Model included patient (as a random effect), treatment, visit (as fixed effect and repeated measure), and treatment-by-visit interaction as explanatory variables, and the baseline symptom score as a covariate along with the baseline symptom score by visit interaction. The covariance structure for repeated measurements within the same patient was specified as unstructured. CI, confidence interval.

      Conclusions:
      Key patient-reported symptoms in the FLAURA trial improved in both treatment arms from baseline over 9 months. Improvements in cough in the two arms were clinically relevant. [1]Soria JC et al. N Engl J Med doi: 10.1056/NEJMoa1713137.

      Clinical trial identification:
      NCT02296125

      Legal entity responsible for the study:
      AstraZeneca

      Funding:
      AstraZeneca

      Disclosure:
      N. Leighl: Research funding to University Health Network in 2015 - unrelated. Honoraria for unrelated CME from: BMS, AZ, Pfizer, Roche. K. Nakagawa: MSD K.K., A2 Healthcare Corp., in Ventiv Health Japan, Astellas Pharma Inc., Daiichi Sankyo Co., Ltd., Novartis Pharma K.K., AbbVie Inc., Quintiles Inc., Icon Japan K.K., Chugai Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., EP-CRSU Co., Ltd., Gritstone Oncology. Inc, Linical Co., Ltd., Eli Lilly Japan K.K., Eisai Co., Ltd., Bristol Myers Squibb Company, Taiho Pharmaceutical Co., Ltd., PAREXEL International Corp., Ono Pharmaceutical Co., Ltd. for Research Funding AstraZeneca K.K., Nichi-Iko Pharmaceutical Co., Ltd., Astellas Pharma Inc. Clinical Trial Co., Ltd, MSD K.K., Taiho Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Bristol Myers Squibb Company, Nippon Boehringer Ingelheim Co., Ltd., Eli Lilly Japan K.K., Novartis Pharma K.K., SymBio Pharmaceuticals Limited., Pfizer Japan Inc. for Honoraria Astellas Pharma Inc., Ono Pharmaceutical Co., Ltd. for Consulting or advisor role. J.E. Gray: Advisor to Astra Zeneca. T. Hovey: Working as a consultant (Phastar Statistician) for AstraZeneca. A. Walding: Employee and shareholder of AstraZeneca R&D. A. Rydén: Employee of AstraZeneca and has AstraZeneca stocks. S. Novello: Speaker bureau: Eli Lilly, AZ, BMS, MSD, Roche. All other authors have declared no conflicts of interest.

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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. Novello

      • 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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