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    Multiple lung tumour nodules (ID 25)

    • Type: Multidisciplinary Tumour Board
    • Presentations: 3
    • Now Available
    • Moderators:
    • Coordinates: 4/11/2019, 16:45 - 17:45, Room B
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    Should we upfront NGS as a standard? (ID 26)

    • Type: Controversy session
    • Presentations: 4
    • Now Available
    • Moderators:
    • Coordinates: 4/11/2019, 16:45 - 17:45, Room A
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    Boehringer Ingelheim - Industry Satellite Symposium (ID 27)

    • Type: Industry Satellite symposium
    • Presentations: 0
    • Moderators:
    • Coordinates: 4/11/2019, 18:00 - 19:00, Room A
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      Meeting welcome and introductions (ID 626)

      18:00 - 18:05  |  Presenting Author(s): Vanesa Gregorc

      • Abstract

      Abstract not provided

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      Prolonging the chemotherapy-free period in EGFRM+ NSCLC (ID 627)

      18:05 - 18:20  |  Presenting Author(s): Nicolas Girard

      • Abstract

      Abstract not provided

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      Q&A: Treating EGFRM+ NSCLC (ID 628)

      18:20 - 18:30  |  Presenting Author(s): Vanesa Gregorc

      • Abstract

      Abstract not provided

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      Recent changes and sequencing strategies in non-mutated, non-squamous advanced NSCLC (ID 629)

      18:30 - 18:45  |  Presenting Author(s): Martin Reck

      • Abstract

      Abstract not provided

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      Q&A: Treating non-mutated, non-squamous NSCLC (ID 630)

      18:45 - 18:55  |  Presenting Author(s): Vanesa Gregorc

      • Abstract

      Abstract not provided

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      Meeting close (ID 631)

      18:55 - 19:00  |  Presenting Author(s): Vanesa Gregorc

      • Abstract

      Abstract not provided

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    Medscape Oncology - Industry Satellite Symposium (ID 28)

    • Type: Industry Satellite symposium
    • Presentations: 0
    • Moderators:
    • Coordinates: 4/11/2019, 18:00 - 19:00, Room C
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      Introduction (ID 632)

      18:00 - 18:05  |  Presenting Author(s): Solange Peters

      • Abstract

      Abstract not provided

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      Testing for ALK-positive disease: The state of the art (ID 633)

      18:05 - 18:20  |  Presenting Author(s): Raffaele Califano

      • Abstract

      Abstract not provided

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      The expanding treatment armamentarium in ALK-positive NSCLC: The evidence (ID 634)

      18:20 - 18:35  |  Presenting Author(s): Marina Chiara Garassino

      • Abstract

      Abstract not provided

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      Case challenge 1: First-line options - Considerations for treatment choice (ID 636)

      18:35 - 18:45  |  Presenting Author(s): Marina Chiara Garassino

      • Abstract

      Abstract not provided

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      Case challenge 2: Second-line treatment selection - How do we choose? (ID 635)

      18:45 - 18:55  |  Presenting Author(s): Raffaele Califano

      • Abstract

      Abstract not provided

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      Conclusions and key points (ID 637)

      18:55 - 19:00  |  Presenting Author(s): Solange Peters

      • Abstract

      Abstract not provided

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    Advanced nursing roles in LCC (ID 52)

    • Type: EONS session
    • Presentations: 4
    • Now Available
    • Moderators:
    • Coordinates: 4/12/2019, 08:30 - 10:00, Room K
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      Introduction (ID 406)

      08:30 - 08:35  |  Presenting Author(s): Daniel Kelly

      • Abstract

      Abstract not provided

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      Advanced nursing practices in thoracic surgery: Improving patient outcomes (Now Available) (ID 407)

      08:35 - 08:55  |  Presenting Author(s): Melissa Culligan

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      Developing advanced practice lung cancer nurses (Now Available) (ID 408)

      08:55 - 09:15  |  Presenting Author(s): Manuela Eicher

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      Evaluation and challenges of advanced practice lung cancer nurses in current context (Now Available) (ID 409)

      09:15 - 09:35  |  Presenting Author(s): Angela mary Tod

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      RECaN: What this project has taught us about advanced roles? (Now Available) (ID 410)

      09:35 - 09:55  |  Presenting Author(s): Daniel Kelly

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      Conclusions (ID 411)

      09:55 - 10:00  |  Presenting Author(s): Melissa Culligan

      • Abstract

      Abstract not provided

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    Biomarker development in I-O (ID 29)

    • Type: Educational session
    • Presentations: 3
    • Now Available
    • Moderators:
    • Coordinates: 4/12/2019, 08:30 - 10:00, Room B
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    Proffered Paper session III (ID 64)

    • Type: Proffered Paper session
    • Presentations: 7
    • Now Available
    • Moderators:
    • Coordinates: 4/12/2019, 08:30 - 10:00, Room A
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      84O - Phase I study of gefitinib (G) + durvalumab (D) for locally advanced/metastatic non-small cell lung cancer (NSCLC) harbouring epidermal growth factor receptor (EGFR) sensitising mutations (Now Available) (ID 180)

      08:30 - 08:42  |  Presenting Author(s): Don L Gibbons  |  Author(s): Benjamin C Creelan, Tammie Yeh, Sang-We Kim, Naoyuki Nogami, Dong-Wan Kim, Laura QM Chow, Shintaro Kanda, Rosemary Taylor, Weifeng Tang, Mei Tang, Helen K Angell, Martine P Roudier, Marcelo Marotti

      • Abstract
      • Presentation
      • Slides

      Background

      G and D have both shown efficacy in patients (pts) with NSCLC; G + D may improve durability of response.

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      This Phase 1 dose escalation (Part A) and expansion (Part B) study (NCT0208811) assessed G 250 mg once daily + D 3 mg/kg (Part A) or 10 mg/kg (Parts A + B) every 2 weeks in pts with locally advanced/metastatic NSCLC. Part A pts were all comers who had failed to respond/relapsed following standard treatment (Tx). Part B pts had sensitising EGFR mutations and were tyrosine kinase inhibitor naïve: Arms 1 + 1a received G + D; Arm 2 received G (4 weeks) before G + D. Primary objective: safety/tolerability. Secondary objectives: pharmacokinetics (PK), pharmacodynamics, immunogenicity (anti-drug antibodies [ADAs]) and efficacy. Exploratory objective: evaluation of biomarkers (e.g. tumour programmed cell death ligand-1 [PD-L1]) and relationship with efficacy.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      There were no dose limiting toxicities in Part A (n = 16) and D 10 mg/kg was used in Part B. In Part B (n = 40) all pts had possible Tx related adverse events (TRAEs; Table): diarrhoea (68%) and elevated alanine aminotransferase (ALT; 58%) were the most common TRAEs; elevated ALT (20%) and aspartate aminotransferase (15%) were the most common TRAEs leading to discontinuation. PK were as expected, inhibition of soluble PD-L1 was observed in all pts and no Tx emergent ADAs were observed. In Arms 1 + 1a, most patients achieved objective response (63.3%; 95% confidence intervals [CI]: 43.9, 80.1), median duration of response was 9.2 months (95% CI: 3.7, 14.0) and median progression-free survival (mPFS) was 10.1 months (95% CI: 5.5, 15.2; Table). PD-L1 expression ≥20% was associated with numerical improvements in mPFS (Table).

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      G + D had a high discontinuation rate due to liver related TRAEs and there was no additional benefit vs historical data for G alone. However, tumours expressing PD-L1 had favourable PFS and could be investigated further.

      b651e8a99c4375feb982b7c2cad376e9 Clinical trial identification

      NCT02088112; March 14, 2014.

      7a6a3ffa2dadc03a6151ee2c4d6fa383 Editorial acknowledgement

      Medical writing support, under the direction of the authors, was provided by Lauren McNally, MSci, of CMC CONNECT, a division of McCann Health Medical Communications Ltd, Glasgow, UK, with funding from AstraZeneca PLC, in accordance with Good Publication Practice (GPP3) guidelines.

      934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study

      MedImmune LLC (a wholly owned subsidiary of AstraZeneca PLC).

      213f68309caaa4ccc14d5f99789640ad Funding

      AstraZeneca PLC.

      682889d0a1d3b50267a69346a750433d Disclosure

      T. Yeh, W. Tang, M. Tang, H.K. Angell, M.P. Roudier, M. Marotti: Employee: AstraZeneca. R. Taylor: Employee, contractor: AstraZeneca. D.L. Gibbons: Advisory boards/research funding: AstraZeneca. All other authors have declared no conflicts of interest.

      cffcb1a185b2d7d5c44e9dc785b6bb25

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      104O - IMpower150: An exploratory analysis of efficacy outcomes in patients with EGFR mutations (Now Available) (ID 184)

      08:42 - 08:54  |  Presenting Author(s): Martin Reck  |  Author(s): Robert Jotte, Tony S.K. Mok, Darren Wan-Teck Lim, Federico Cappuzzo, Francisco Orlandi, Daniil Stroyakovskiy, Naoyuki Nogami, Delvys Rodríguez-Abreu, Denis Moro-Sibilot, Christian A. Thomas, Fabrice Barlesi, Gene Finley, Makoto Nishio, Anthony Lee, Geetha Shankar, Wei Yu, Mark A. Socinski

      • Abstract
      • Presentation
      • Slides

      Background

      Atezolizumab (atezo; anti–PD-L1) inhibits PD-L1 to restore anticancer immunity; bevacizumab (bev) may enhance atezo efficacy by inhibiting VEGF immunosuppression and promoting T-cell tumour infiltration. Atezo + bev + chemotherapy (chemo) prolonged PFS and OS vs bev + CP in pts with first-line nonsquamous NSCLC in the randomised Ph III IMpower150 study, including pts with EGFR or ALK genomic alterations. The purpose of this analysis is to focus on the efficacy of atezo and/or bev with chemo in pts with EGFR mutations (EGFR-mt).

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      The 1202 enrolled pts received atezo (A) 1200 mg + bev (B) 15 mg/kg + carboplatin (C) AUC 6 + paclitaxel (P) 200 mg/m2 (ABCP) or A + C + P (ACP) or B + C + P (BCP) by IV q3w for 4 or 6 cycles per investigator (INV) decision, then q3w maintenance with atezo + bev, atezo or bev, respectively. Primary endpoints were OS and INV-assessed PFS in the ITT–wild-type population (pts with no EGFR or ALK genomic alterations). Exploratory analyses included OS and INV-assessed PFS in pts with EGFR-mt disease, pts with sensitising EGFR-mt and pts with EGFR-mt disease with prior TKI therapy.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      These data represent ≥ 20-mo follow-up (data cutoff: 22 Jan 2018) in the ITT population. 124 pts were EGFR-mt; 91 with a sensitising mutation. Baseline characteristics of EGFR-mt pts across treatment arms were generally comparable to the ITT population. OS was improved with ABCP vs BCP in EGFR-mt pts, especially in pts with sensitising EGFR-mts (HR, 0.31 [95% CI: 0.11, 0.83]). This benefit extended to PFS (HR, 0.41 [95% CI: 0.23, 0.75]). See table for full efficacy results. Safety was similar between the EGFR-mt and ITT populations.

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      IMpower150 is the first randomised Ph III trial of a checkpoint inhibitor to show a benefit in pretreated EGFR-mt pts. Adding atezo to standard-of-care bev and chemo provided survival benefit in EGFR-mt pts who have failed TKIs, for whom this regimen may represent a new treatment option.

      b651e8a99c4375feb982b7c2cad376e9 Clinical trial identification

      NCT02366143.

      7a6a3ffa2dadc03a6151ee2c4d6fa383 Editorial acknowledgement

      Medical writing assistance for this abstract was provided by Jessica Men, PharmD, of Health Interactions and funded by F. Hoffmann-La Roche, Ltd.

      934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study

      F. Hoffmann-La Roche, Ltd.

      213f68309caaa4ccc14d5f99789640ad Funding

      F. Hoffmann-La Roche, Ltd.

      682889d0a1d3b50267a69346a750433d Disclosure

      M. Reck: Speakers bureau, consulting, advisory role: Roche, Lilly, Pfizer, BI, AZ, MSD, BMS, Merck, Novartis, Celgene; Other (support of parent study, funding of editorial support): Roche. R. Jotte: Speakers bureau; travel, accommodations, expenses: Bristol-Myers Squibb; Other (support of parent study, funding of editorial support): Roche. T.S.K. Mok: Honoraria, consult/ad role, research: AZ, BI, BMS, Merck, NVS, Pfizer, Roche/GNE; Honoraria, consult/ad role: LLY; Consult/Ad Role: ACEA, Celgene, geneD, Ignyta, OGXI, Vertex; Consult/ad role, research: Clovis, SFJ; Research: Eisai, Taiho; Stock: Sanomics, Hutch. D.W-T. Lim: Honoraria: AZ, BI, Novartis, MSD, Pfizer, Roche, Takeda, Taiho; Research grants (institution): BMS; Stock: Clearbridge Biomedics Pte Ltd, Mesh Bio Pte Ltd; Other (support of parent study, funding of editorial support): Roche. F. Cappuzzo: Speakers/Advisory board: Roche, AZ, BMS, Pfizer, MSD, Takeda; Other (support of parent study, funding of editorial support): Roche. F. Orlandi: Consult/ad role: AZ, Lilly; Consult/ad role, travel, research: Roche, BMS, MSD; Consult/ad role, travel: Pfizer; Speaker, travel, research: MedImm; Research: Amgen, BI, Astellas, Celltrion. D. Stroyakovskiy, C.A. Thomas: Support of parent study, funding of editorial support: Roche. N. Nogami: Honoraria: AZ, Pfizer, Ono Pharmaceutical, Kyowa Hakko Kririn, Taiho, Chugai, Eli Lilly, BI, MSD; Other (support of parent study and funding of editorial support): Roche. D. Rodríguez-Abreu: Speakers bureau: MSD, Roche, BMS, AZ, Pfizer; Other (support of parent study and funding of editorial support): Roche. D. Moro-Sibilot: Honoraria; Consulting/advisory role, travel, accommodations, expenses: Roche, MSD, Pfizer, BMS, AZ; Honoraria, consulting/advisory role: Novartis, Lilly; Other (support of parent study, funding of editorial support): Roche. F. Barlesi: Support of parent study, funding of editorial support: Roche; Personal fees: AZ, BMS, BI, Clovis, Lilly, Roche, Novartis, Merck, MSD, Pierre Fabre, Pfizer, Takeda; Consulting/advisory: MSD, Takeda. G. Finley: Speakers: BMS, BI, Astellas Medivation, Merck; Support of parent study, funding of editorial support: Roche. M. Nishio: Speakers/Ad board, research grant: Ono Pharma, BMS, Pfizer, Chugai, Lilly, Taiho, AZ, MSD, Novartis; Speakers/Ad board: BI, Sankyo, Merck; Research Grant: Astellas; Support of parent study, funding of editorial support: Roche. A. Lee: Employee/Stock: Genentech; Support of parent study, funding of editorial support: Roche. G. Shankar, W. Yu: Employee: Genentech; Support of parent study, funding of editorial support: Roche. M.A. Socinski: Honoraria/speakers bureau/research funding: Genentech; Support of parent study, funding of editorial support: Roche.

      cffcb1a185b2d7d5c44e9dc785b6bb25

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      105O - Osimertinib for patients (pts) with leptomeningeal metastases (LM) associated with EGFRm advanced NSCLC: The AURA LM study (Now Available) (ID 178)

      08:54 - 09:06  |  Presenting Author(s): Myung-Ju Ahn  |  Author(s): Chao-Hua Chiu, Ying Cheng, Ji-Youn Han, Sarah B. Goldberg, Alastair Greystoke, Jeffrey Crawford, Yanqiu Zhao, Xiangning Huang, Martin Johnson, Karthick Vishwanathan, Ariadna Mendoza-Naranjo, Tony S.K. Mok

      • Abstract
      • Presentation
      • Slides

      Background

      Osimertinib, a 3rd-generation EGFR-TKI selective for both sensitising and EGFR T790M resistance mutations, has shown efficacy in pts with CNS metastases; encouraging activity has been reported in pts with LM at 160 mg once daily (QD) (BLOOM; NCT02228369). We report LM activity with osimertinib 80 mg QD in pts with LM from studies across the AURA program (NCT01802632; NCT02094261; NCT02442349; NCT02151981).

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      Pts with EGFR T790M positive advanced NSCLC and progression on EGFR-TKI received osimertinib 80 mg QD. Patients with LM and CNS metastases were eligible if asymptomatic and stable. Baseline brain scans were mandated in pts with known or treated CNS metastases at study entry; pts with evidence of LM by neuroradiological blinded independent review (BICR) were included for retrospective analysis. Follow-up brain scans were assessed for radiologic LM response by LM BICR per Response Assessment in Neuro-Oncology LM criteria. LM objective response rate (ORR), LM duration of response (DoR), LM progression-free survival (PFS) and overall survival (OS) were assessed retrospectively. Results are based on individual data cutoffs for each study. A longitudinal analysis overlaid changes from baseline non-CNS tumour size with LM responses at each visit for AURA LM and BLOOM LM pts.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      22 LM pts from the AURA studies were included for analysis. Median treatment exposure was 7.3 mo (range 2.3–16.5). Baseline characteristics were broadly consistent with the overall AURA study population: median age 58 yrs; female 59%; Asian 82%; WHO PS 1 82%. LM ORR was 55% (95% CI 32, 76); complete or partial LM response reported in 6 pts (27%) each. Median LM DoR was not reached (95% CI 2.8, not calculable [NC]). Median LM PFS was 11.1 mo (95% CI 4.6, NC). OS was 18.8 mo (95% CI 6.3, NC). Graphical assessment of longitudinal analysis showed similar non-CNS and LM responses in AURA LM and BLOOM LM pts.

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      Consistent with early efficacy outputs from BLOOM (160mg QD), osimertinib 80 mg QD showed a clinically meaningful benefit in pts with T790M-positive NSCLC and radiographically-detected LM. Additional studies are needed to further evaluate the CNS efficacy of osimertinib 80 mg QD in pts with EGFRm NSCLC and LM.

      b651e8a99c4375feb982b7c2cad376e9 Clinical trial identification

      AURA extension (NCT01802632), AURA2 (NCT02094261), AURA3 (NCT02151981), AURA17 (NCT02442349).

      7a6a3ffa2dadc03a6151ee2c4d6fa383 Editorial acknowledgement

      Medical support was provided by Robert Harrison, PhD, of iMed Comms, Macclesfield, UK, an Ashfield Company, part of UDG Healthcare plc, and funded by AstraZeneca, Cambridge, UK, in accordance with Good Publications Practice (GPP3) guidelines.

      934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study

      AstraZeneca.

      213f68309caaa4ccc14d5f99789640ad Funding

      AstraZeneca.

      682889d0a1d3b50267a69346a750433d Disclosure

      M-J. Ahn: Speakers’ bureau: AstraZeneca, MSD, ONO, Lilly, Roche; Consultant: Alpha Pharmaceutical. C-H. Chiu: Honorarium: AZ, BI, Novartis, Pfizer, Roche. J-Y. Han: Honoraria: Roche, AstraZeneca, BMS, MSD; Advisory role: AstraZeneca, BMS, MSD, Lilly, Novartis, Pfizer; Research fund: Roche, Pfizer, ONO. S.B. Goldberg: Research support: AstraZeneca; Advisory board member: AstraZeneca, Boehringer Ingelheim, Eli Lilly, Bristol-Myers Squibb, Genentech, Amgen, Spectrum. A. Greystoke: Consultancy fees, speaker fees: AstraZeneca. J. Crawford: Scientific advisor: Amgen, Enzychem, Merck, Pfizer; Consultant: Amgen, AstraZeneca, Coherus, Enzychem, Merck, Pfizer; Research support: AstraZeneca, Genentech, Helsinn; Chair/DSMB member: Beyond Spring, G1 Therapeutics, Janssen, Merrimack, Mylan, Roche. X. Huang, M. Johnson, K. Vishwanathan, A. Mendoza-Naranjo: Employee, shareholder: AstraZeneca. T.S.K. Mok: Leadership (for-profit): ChiMed, Sanomics Ltd.; Leadership (non-profit): IASLC, ASCO, Chinese Society of Clinical Oncology; Shareholder: Sanomics Ltd.; Honoraria: AZ, BI, Roche/Genentech, Pfizer, Lilly, Merck Serono, MSD, Novartis, SFJ, ACEA, Vertex, BMS, Oncogenex, Celgene, Ignyta, Cirina, Fishawack Facilitate, Takeda Oncology, Janssen, ChiMed; Consulting/advisory role: AZ, BI, Roche/Genentech, Pfizer, Lilly, Merck Serono, MSD, Novartis, SFJ Company, ACEA, Vertex, BMS, GeneDecode, Oncogenex, Celgene, Ignyta, Cirina, Fishawack Facilitate, Janssen, Takeda Oncolog, ChiMed; Research funding: AZ, BI, Pfizer, Novartis, SFJ, Roche, MSD, Clovis Oncology, BMS, Eisai, Taiho, Merck Serono, XCovery. All other authors have declared no conflicts of interest.

      cffcb1a185b2d7d5c44e9dc785b6bb25

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      Invited Discussant 84O, 104O and 105O (Now Available) (ID 677)

      09:06 - 09:21  |  Presenting Author(s): Pasi Antero Jänne

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      106O - Brigatinib (BRG) vs crizotinib (CRZ) in the phase III ALTA-1L trial (Now Available) (ID 166)

      09:21 - 09:33  |  Presenting Author(s): Raffaele Califano  |  Author(s): Maximilian J Hochmair, Cesare Gridelli, Angelo Delmonte, Maria Rosario Garcia Campelo, Alessandra Bearz, Frank Griesinger, Alessandro Morabito, Enriqueta Felip, Sharmistha Ghosh, Marcello Tiseo, Jeff Haney, David Kerstein, Sanjay Popat, D. Ross Camidge

      • Abstract
      • Presentation
      • Slides

      Background

      We report results of the first interim analysis (IA) from the ALTA-1L study of BRG vs CRZ in anaplastic lymphoma kinase (ALK) inhibitor–naive, ALK-positive non–small cell lung cancer (ALK+ NSCLC; NCT02737501).

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      This open-label, multicenter study enrolled patients (pts) with advanced ALK+ NSCLC. Eligible pts had ≤1 prior systemic therapy for advanced NSCLC. Asymptomatic central nervous system (CNS) metastases were allowed. Pts were randomized 1:1 to BRG 180 mg QD with 7-day lead-in at 90 mg or CRZ 250 mg BID. Primary endpoint was blinded independent review committee (BIRC)-assessed progression-free survival (PFS; RECIST v1.1); secondary efficacy endpoints included BIRC-assessed objective response rate (ORR), intracranial ORR (iORR), and intracranial PFS (iPFS). IAs were planned at 50% and 75% of 198 expected PFS events.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      275 pts were randomized (BRG/CRZ, n = 137/138); median age (years) 58/60. 26%/27% received prior chemotherapy for advanced disease, and 29%/30% had baseline brain metastases. At data cutoff (19 Feb 2018), with a median follow-up of 11.0/9.3 months (BRG/CRZ) and 99 PFS events, BRG met the prespecified threshold for statistical superiority vs CRZ in the primary endpoint of BIRC-assessed PFS (HR 0.49; 95% CI, 0.33–0.74; log-rank P = 0.0007); BRG median PFS was not reached (NR; 95% CI, NR) vs CRZ 9.8 months (95% CI, 9.0–12.9). Investigator-assessed PFS HR 0.45 (95% CI, 0.30–0.68); log-rank P = 0.0001. Table shows additional efficacy data. Most common grade ≥3 treatment-emergent adverse events (AEs): BRG: increased blood creatine phosphokinase (16.2%) and lipase (13.2%), hypertension (9.6%); CRZ: increased alanine aminotransferase (9.5%), aspartate aminotransferase (5.8%), and lipase (5.1%). Any grade interstitial lung disease/pneumonitis: BRG, 3.7%; CRZ, 2.2%. Discontinuations due to AE (BRG/CRZ): 11.8%/8.8%.

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      BRG showed a statistically and clinically significant improvement in PFS vs CRZ in ALK inhibitor–naive ALK+ NSCLC.

      b651e8a99c4375feb982b7c2cad376e9 Clinical trial identification

      NCT02737501.

      7a6a3ffa2dadc03a6151ee2c4d6fa383 Editorial acknowledgement

      Professional medical writing assistance was provided by Lauren Gallagher, PhD, (Peloton Advantage, Parsippany, NJ) and funded by Millennium Pharmaceuticals, Inc.

      934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study

      ARIAD Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.

      213f68309caaa4ccc14d5f99789640ad Funding

      ARIAD Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.

      682889d0a1d3b50267a69346a750433d Disclosure

      R. Califano: Honoraria, consulting/advisory role: AstraZeneca, BMS, Roche, MSD, Boehringer Ingelheim, Takeda, Novartis, Pfizer, Lilly Oncology. C. Gridelli: Speakers bureau, advisory role: Pfizer, Roche. A. Delmonte: Consulting/advisory role: AstraZeneca, Boehringer Ingelheim. M.R. Garcia Campelo: Honoraria: ARIAD, AstraZeneca, Roche, Pfizer, BMS, Boehringer Ingelheim; Speakers bureau, advisory role: ARIAD, AstraZeneca, Roche, Pfizer, BMS, Boehringer Ingelheim. A. Bearz: Speakers bureau, advisory role: AstraZeneca, Pfizer, Eli Lilly, BMS, Novartis, Roche, MSD, Boehringer Ingelheim, Takeda. F. Griesinger: Research funding to institution: AstraZeneca, Boehringer Ingelheim, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, Takeda, Siemens; Consulting or advisory role: ARIAD, AstraZeneca, Boehringer Ingelheim, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, Takeda, ARIAD, AbbVie, Siemens. E. Felip: Consulting/advisory role: AbbVie, AstraZeneca, Blue Print Medicines, Boehringer Ingelheim, BMS, Celgene, Eli Lilly, Guardant Health, Janssen, Merck KGaA, MSD, Novartis, Pfizer, Roche, Takeda; Speakers bureau: AbbVie, AstraZeneca, Boehringer Ingelheim, BMS, Eli Lilly, Merck KGaA, MSD, Novartis, Pfizer, Roche, Takeda. S. Popat: Research funding to institution: Boehringer Ingelheim, Epizyme, BMS, Clovis Oncology, Roche, Lilly, Takeda; Honoraria: Boehringer Ingelheim, AstraZeneca, Roche, Takeda, Chugai Pharma; Consulting or advisory role: Boehringer Ingelheim, Roche, Novartis, Pfizer, AstraZeneca, BMS, MSD, Guardant Health, AbbVie; Travel, accommodations, expenses: Boehringer Ingelheim, BMS, Merck Sharp & Dohme. A. Morabito: Honoraria: AstraZeneca, Roche, Boehringer Ingelheim, Pfizer, MSD, BMS. S. Ghosh: Honoraria/speakers bureau: Pfizer. M. Tiseo: Speakers bureau, advisory role: AstraZeneca, BMS, Boehringer Ingelheim, Eli Lilly, MSD, Novartis, Otsuka, Pfizer, Pierre Fabre, Roche. J. Haney, D. Kerstein: Employment, stock and other ownership interests: Arîad. D.R. Camidge: Honoraria: AstraZeneca, Takeda, Arrys/Kyn, Genoptix, G1 Therapeutics (DSMB), Mersana Therapeutics, Roche/Genentech, Ignyta, Daichii Sankyo (ILD adjudication committee), Hansoh SRC, Bio-Thera DSMB, Lycera, Revolution Med, Orion, Clovis, Celgene, Novartis); Research funding (ARIAD/Takeda). All other authors have declared no conflicts of interest.

      cffcb1a185b2d7d5c44e9dc785b6bb25

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      107O - Crizotinib in advanced ROS1-rearranged non-small cell lung cancer (NSCLC): Overall survival (OS) and updated safety from PROFILE 1001 (Now Available) (ID 197)

      09:33 - 09:45  |  Presenting Author(s): Alice Shaw  |  Author(s): Gregory J Riely, Yung-Jue Bang, Dong-Wan Kim, D. Ross Camidge, Geoffrey I. Shapiro, Tiziana Usari, Sherry C. Wang, Keith Wilner, Jeffrey W. Clark, Sai-Hong Ignatius Ou

      • Abstract
      • Presentation
      • Slides

      Background

      In the ongoing phase 1 PROFILE 1001 study (NCT00585195), crizotinib provided a meaningful clinical benefit for patients (pts) with advanced ROS1-rearranged NSCLC, as evidenced by a high objective response rate (72%) and rapid, substantial and durable responses (median duration of response, 18 months [mo]); in addition, crizotinib was well-tolerated (Shaw, N Engl J Med, 2014). Here, we present OS results and updated safety (additional follow-up >3 years) in these pts.

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      Pts with histologically confirmed NSCLC containing ROS1 rearrangements were enrolled and treated with oral crizotinib 250 mg twice daily (BID). ROS1 status was assessed by fluorescence in situ hybridization or reverse transcriptase polymerase chain reaction.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      Between October 2010 and June 2018, 53 pts with ROS1-rearranged NSCLC were treated with crizotinib; median duration of treatment was 22 mo (95% confidence interval [CI]: 15, 36). At the time of data cutoff (June 30, 2018), 12 pts (22.6%) remained on treatment. A total of 26 deaths (49.1%) occurred over a median follow-up period of 63 mo. Median OS was 51 mo (95% CI: 29, not reached) and the probabilities of survival at 12, 24 and 48 mo were 78.8%, 67.0% and 50.7%, respectively. With a median treatment duration nearly 8 mo longer than that for the primary endpoint analysis and 30.2% of patients on treatment for more than 4 years, no new safety signals were noted. The most common grade 3 treatment-related adverse events (TRAEs; in ≥ 5% of pts) were hypophosphatemia (15.1%) and neutropenia (9.4%); no grade 4 TRAEs or treatment-related deaths were reported. With longer follow-up, there were no permanent discontinuations associated with TRAEs.

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      The results of the OS analysis and updated safety information from PROFILE 1001 continue to support the favorable benefit/risk profile of crizotinib 250 mg BID for the treatment of patients with advanced ROS1-positive NSCLC.

      b651e8a99c4375feb982b7c2cad376e9 Clinical trial identification

      NCT00585195.

      7a6a3ffa2dadc03a6151ee2c4d6fa383 Editorial acknowledgement

      Editorial assistance was provided by Vasupradha Vethantham, PhD, of inScience Communications, Springer Healthcare (New York, NY, USA), with funding from Pfizer, Inc.

      934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study

      Pfizer, Inc.

      213f68309caaa4ccc14d5f99789640ad Funding

      Pfizer, Inc.

      682889d0a1d3b50267a69346a750433d Disclosure

      A. Shaw: Fees for consulting/advisory board roles: ARIAD/Takeda, Blueprint Medicines, Daiichi Sankyo, EMD Serono, Foundation Medicine Genentech, Ignyta, KSQ Therapeutics, Loxo, Novartis, Pfizer, Roche, Taiho; Honoraria: Novartis, Pfizer, Roche; Research funding to institution: Daiichi Sankyo, Ignyta, Novartis, Pfizer, Roche/Genentech, TP Therapeutics. Y-J. Bang: Advisory boards: Astellas, AstraZeneca, Bayer, BeiGene, Bristol-Myers Squibb, Daiich-Sankyo, Eli Lilly, GreenCross, Genentech/Roche, Hanmi, Novartis,  Merck Serano,  MSD, Samyang Biopharm, Taiho; Research funding to institution: Astellas, AstraZeneca, Bayer, BeiGene, Bristol-Myers Squibb, Boeringer Ingelheim, Boston Biomedical, CKD Pharma, Curis, Daiichi Sankyo, Eli Lilly, FivePrime, Glaxo Smith-Kline, Genentech/Roche, Green Cross, MacroGenics, Merck Serano, MSD, Novartis, Pfizer, Ono, Takeda, Taiho. D.R. Camidge: Advisory boards: AbbVie, ARIAD, Array, Celgene, Clovis, Eli Lilly, G1 Therapeutics (DSMB), Genoptix, Ignyta, Mersana Therapeutics, Novartis, Orion, Roche/Genentech, Takeda; Research for investigator-initiated trials: ARIAD, Takeda. G.J. Riely: Funding to institution: Pfizer for the conduct of this research; Research support to institution: Novartis, Roche, Takeda. Compensated consultant: Genentech/Roche. G.I. Shapiro: Research funding to the Dana-Farber Cancer Institute: Pfizer for the conduct of the study; Advisory boards: Eli Lilly, G1 Therapeutics, Merck/EMD Serono, Roche, Pfizer, Vertex Pharmaceuticals. T. Usari, S.C. Wang, K. Wilner: Employee, holds stock: Pfizer. J.W. Clark: Institutional research funding: Pfizer. S-H.I. Ou: Fees for consulting/Advisory board: Pfizer; Research funding to institution: Eli Lilly, Merck/EMD Serono, Pfizer. All other authors have declared no conflicts of interest.

      cffcb1a185b2d7d5c44e9dc785b6bb25

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      Invited Discussant 106O and 107O (Now Available) (ID 678)

      09:45 - 10:00  |  Presenting Author(s): Natasha Leighl

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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    Coffee break (ID 31)

    • Type: Coffee break
    • Presentations: 0
    • Moderators:
    • Coordinates: 4/12/2019, 10:00 - 10:30, Hall 1
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    Family caregivers in LCC (ID 53)

    • Type: EONS session
    • Presentations: 4
    • Now Available
    • Moderators:
    • Coordinates: 4/12/2019, 10:30 - 12:00, Room K
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    Genetic heterogeneity and clonal evolution (ID 32)

    • Type: Special Symposium
    • Presentations: 4
    • Now Available
    • Moderators:
    • Coordinates: 4/12/2019, 10:30 - 12:00, Room B
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      Clonal evolution in lung cancer (Now Available) (ID 84)

      10:30 - 10:50  |  Presenting Author(s): Nicholas McGranahan

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      Immune microenvironment and cancer evolution (Now Available) (ID 83)

      10:50 - 11:10  |  Presenting Author(s): Michael Hölzel

      • Abstract
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      Abstract not provided

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      Elucidating EGFR evolution (Now Available) (ID 82)

      11:10 - 11:30  |  Presenting Author(s): Daniel Shao Weng Tan

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      Abstract not provided

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      Challenges in tracking clonal evolution (Now Available) (ID 85)

      11:30 - 11:50  |  Presenting Author(s): Martin Peifer

      • Abstract
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      Abstract not provided

      Information from this presentation has been removed upon request of the author.

      Information from this presentation has been removed upon request of the author.