Virtual Library

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    A decade of targeting EGFR (ID 35)

    • Event: ELCC 2019
    • Type: Keynote Lecture
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/12/2019, 12:10 - 12:40, Room B
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      A decade of targeting EGFR (ID 92)

      12:10 - 12:40  |  Presenting Author(s): Tony S.K. Mok

      • Abstract
      • Presentation
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      Abstract not provided

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    Biomarker development in I-O (ID 29)

    • Event: ELCC 2019
    • Type: Educational session
    • Track:
    • Presentations: 3
    • Moderators:
    • Coordinates: 4/12/2019, 08:30 - 10:00, Room B
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      Biomarkers for I-O (ID 77)

      08:30 - 10:00  |  Presenting Author(s): Lukas Bubendorf

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      Abstract not provided

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      Role of biomarkers in resistance (ID 79)

      08:30 - 10:00  |  Presenting Author(s): Ross Andrew Soo

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      Abstract not provided

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      How to implement immuno biomarkers in clinical practice (ID 80)

      08:30 - 10:00  |  Presenting Author(s): Santiago Ramon y Cajal

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      Abstract not provided

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    ESMO-IASLC Best Abstracts (ID 62)

    • Event: ELCC 2019
    • Type: Proffered Paper session
    • Track:
    • Presentations: 6
    • Moderators:
    • Coordinates: 4/11/2019, 14:45 - 16:15, Room B
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      LBA1_PR - Nivolumab (nivo) plus ipilimumab (ipi), nivo, or placebo (pbo) as maintenance therapy in patients (pts) with extensive disease small cell lung cancer (ED-SCLC) after first-line (1L) platinum-based chemotherapy (chemo): Results from the double-blind, randomized phase III CheckMate 451 study (ID 683)

      14:45 - 16:15  |  Presenting Author(s): Taofeek K Owonikoko  |  Author(s): Hye Ryun Kim, Ramaswamy Govindan, Neal Ready, Martin Reck, Solange Peters, Shaker R. Dakhil, Alejandro Navarro, Jeronimo Rodriguez-Cid, Michael Schenker, Jong S. Lee, Vanesa Gutierrez, Ivor Percent, Daniel Morgensztern, Justin Fairchild, Christine Baudelet, Keunchil Park

      • Abstract
      • Presentation
      • Slides

      Background

      In pts with ED-SCLC, response rates to 1L platinum-based chemo are high but lack durability. Treatments (txs) that prolong response duration and improve survival are needed. CheckMate 451 (NCT02538666) is a global, double-blind, phase 3 study of nivo+ipi or nivo vs pbo as maintenance therapy in pts with ED-SCLC who did not progress on 1L platinum-based chemo.

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      Pts (N = 834) with ED-SCLC, ECOG performance status (PS) ≤ 1 and response or stable disease after 4 cycles of 1L platinum-based chemo were randomized 1:1:1 (3–9 weeks from last dose of 1L chemo or 3–11 weeks for pts who received prophylactic cranial irradiation [PCI]) to nivo 1 mg/kg + ipi 3 mg/kg Q3W intravenously (IV; 4 doses followed by nivo 240 mg Q2W IV; n = 279), nivo 240 mg Q2W IV (n = 280), or pbo (n = 275), stratified by PS, sex and prior PCI. Pts were treated up to 2 years or until progression or unacceptable toxicity. Primary endpoint was overall survival (OS) for nivo+ipi vs pbo. Secondary endpoints included OS for nivo vs pbo and progression-free survival (PFS) per blinded independent central review for nivo+ipi vs pbo and nivo vs pbo.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      Minimum study follow-up was 9 months. Baseline characteristics were balanced between arms. OS was not significantly prolonged with nivo+ipi vs pbo (HR, 0.92; 95% CI 0.75–1.12; P = 0.3693). OS was also not prolonged for nivo vs pbo (HR, 0.84; 95% CI 0.69–1.02), although not formally tested due to statistical hierarchy. PFS HRs vs pbo were: nivo+ipi, 0.72 (0.60–0.87); nivo, 0.67 (0.56–0.81). Rates of all-grade (grade 3–4) tx-related adverse events were: nivo+ipi, 86% (52%); nivo, 61% (12%); pbo, 50% (8%). Rates of discontinuation due to tx toxicity were: nivo+ipi, 31%; nivo, 9%; pbo, <1%. Tx-related deaths were: nivo+ipi, 7 (2.5%); nivo, 1 (<1%); pbo, 1 (<1%).

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      In CheckMate 451, maintenance therapy with nivo+ipi (primary endpoint) or nivo did not prolong OS vs pbo for ED-SCLC patients who did not progress on 1L chemo. Safety profiles of nivo+ipi and nivo were consistent with previous reports at this dose/schedule in SCLC.

      b651e8a99c4375feb982b7c2cad376e9 Clinical trial identification

      NCT02538666; Release date: 2 September 2015.

      7a6a3ffa2dadc03a6151ee2c4d6fa383 Editorial acknowledgement

      Writing and editorial assistance was provided by Cristina Tomas, PhD, of Caudex and funded by Bristol-Myers Squibb.

      934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study

      Bristol-Myers Squibb.

      213f68309caaa4ccc14d5f99789640ad Funding

      Bristol-Myers Squibb.

      682889d0a1d3b50267a69346a750433d Disclosure

      T.K. Owonikoko: Research support: AbbVie, Adaptimmune, Amgen, AstraZeneca, Bristol-Myers Squibb, Corvus, G1 Therapeutics, Novartis, Pfizer, Regeneron/Sanofi; Advisory board: AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Lilly/Armo, PharmaMar, Xcovery; IRC/DSMB: EMD Serono, Roche/Genentech; Co-founder: Cambium Oncology. H.R. Kim: Speakers bureau, honoraria: AstraZeneca, ONO/Bristol-Myers Squibb; Consultant: Roche. R. Govindan: Consultant/advisory committees: AbbVie, Adaptimmune, AstraZeneca, Celgene, Ignyta, Inivata, Merck, Nektar, Pfizer, Roche. N. Ready: Advisor: AbbVie, G1 therapeutics, Merck, Novartis; Advisor/speaker: Bristol-Myers Squibb, Celgene; Education: AstraZeneca, EMD Serrano, Tesaro. M. Reck: Honoraria for lectures and consultancy: AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Lilly, Merck, MSD, Novartis, Pfizer, Roche. S. Peters: Honoraria, education grants, consultancy, attended advisory boards, and/or provided lectures: AbbVie, Amgen, AstraZeneca, Bayer, Biocartis, Boehringer Ingelheim, Bristol-Myers Squibb, Clovis, Daiichi Sankyo, Debiopharm, Eli Lilly, F. Hoffmann-La Roche, Foundation Medicine, Illumina, Janssen, Merck Sharp and Dohme, Merck Serono, Merrimack, Novartis, PharmaMar, Pfizer, Regeneron, Sanofi, Seattle Genetics, Takeda. A. Navarro: Advisory role: Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, Roche; Safety committee member: Oryzon Genomics; Travel support: Boehringer Ingelheim, Pfizer. J. Rodriguez-Cid: Investigational resources: AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, MSD, Novartis, Roche, Takeda; Advisory role: AbbVie, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Eisai, MSD, Novartis, Pfizer, Roche, Takeda; Speaker role: AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, Takeda. M. Schenker: For clinical trial participation (as PI/SI) my institution and I have received funds from: AbbVie, Amgen, Astellas, AstraZeneca, Bayer, Bioven, Bristol-Myers Squibb, Eisai, Eli Lilly, Gilead, Merck Serono, MSD, Mylan, Nano Carrier, Novartis, Pfizer, PharmaMar, Regeneron, Roche, Samsung D. Morgensztern: Advisory board: AbbVie, Bristol-Myers Squibb, PharmaMar, Takeda. J. Fairchild: Stock ownership: Bristol-Myers Squibb. C. Baudelet: Employee: Bristol-Myers Squibb. K. Park: Advisor: Bristol-Myers Squibb. All other authors have declared no conflicts of interest.

      cffcb1a185b2d7d5c44e9dc785b6bb25

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      LBA3 - Efficacy and safety of first-line durvalumab (D) ± tremelimumab (T) vs platinum-based chemotherapy (CT) based on clinical characteristics in patients with metastatic (m) NSCLC: Results from MYSTIC (ID 376)

      14:45 - 16:15  |  Presenting Author(s): Byoung Chul Cho  |  Author(s): Niels Reinmuth, Ki Hyeong Lee, Myung-Ju Ahn, Alexander Luft, Michael Van den Heuvel, Manuel Cobo Dols, Alexey Smolin, David Vicente, Vladimir Moiseyenko, Scott J. Antonia, Sylvestre Le Moulec, Gilles Robinet, Ronald Natale, Edward B Garon, Kazuhiko Nakagawa, Feng Liu, Piruntha Thiyagarajah, Solange Peters, Naiyer A Rizvi

      • Abstract
      • Presentation
      • Slides

      Background

      In MYSTIC (NCT02453282), an open-label, Phase 3 trial of first-line D (anti-PD-L1) ± T (anti-CTLA-4) vs CT in mNSCLC, while not statistically significant, a clinically meaningful improvement in overall survival (OS) was seen with D vs CT in pts with tumour cell PD-L1 expression ≥25% (TC ≥25% [primary analysis population]; D vs CT, HR 0.76 [97.54% CI 0.56–1.02], p=0.036; D+T vs CT, HR 0.85 [98.77% CI 0.61–1.17], p=0.202). Here we report OS in clinically relevant pt subgroups and safety results from MYSTIC.

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      Immunotherapy/CT-naïve pts with mNSCLC were randomised (1:1:1) to D (20 mg/kg q4w); D (20 mg/kg q4w) + T (1 mg/kg q4w for 4 cycles); or CT. OS was analysed in pt subgroups based on baseline clinical characteristics in the PD-L1 TC ≥25% population (prespecified: age, gender, race, histology, smoking history and immune cell [IC] PD-L1 expression ≥25% vs <25%; post hoc: ECOG performance status). Safety (CTCAE v4.03) and tolerability were evaluated in all treated pts.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      The subgroup analysis included 488 pts (D, 163; D+T, 163; CT, 162). Baseline characteristics were balanced between treatment groups. Treatment with D±T resulted in numerical improvement in OS vs CT in most clinical subgroups. OS in pts aged ≥65 y, PD-L1 IC ≥25%, and performance status 0 showed a HR (95% CI) of 0.66 (0.45, 0.95), 0.63 (0.38, 1.04), and 0.54 (0.34, 0.84), respectively, with D vs CT and a HR (95% CI) of 0.72 (0.50, 1.02), 0.64 (0.39, 1.05), and 0.76 (0.50, 1.14) with D+T vs CT. Rates of TRAEs leading to discontinuation and imAEs were highest with D+T and rates of Grade ≥3 TRAEs were highest with CT (Table).

      D (n=369)D+T (n=371)CT (n=352)
      Any TRAE leading to discontinuation (PT), n (%)20 (5.4)49 (13.2)33 (9.4)
      →Pneumonitis3 (0.8)7 (1.9)1 (0.3)
      →Interstitial lung disease2 (0.5)5 (1.3)1 (0.3)
      →Blood creatinine increased01 (0.3)4 (1.1)
      →Colitis05 (1.3)0
      →Diarrhoea04 (1.1)1 (0.3)
      Any Grade ≥3 TRAE (PT), n (%)55 (14.9)85 (22.9)119 (33.8)
      →Anaemia0036 (10.2)
      →Neutropenia1 (0.3)035 (9.9)
      →Fatigue6 (1.6)8 (2.2)7 (2.0)
      →Thrombocytopenia0018 (5.1)
      →Lipase increased3 (0.8)13 (3.5)1 (0.3)
      Any imAE (grouped term), n (%)50 (13.6)105 (28.3)12 (3.4)
      →Hypothyroidism21 (5.7)28 (7.5)2 (0.6)
      →Pneumonitis8 (2.2)25 (6.7)5 (1.4)
      →Diarrhoea7 (1.9)17 (4.6)1 (0.3)
      →Rash5 (1.4)16 (4.3)2 (0.6)
      →Colitis2 (0.5)12 (3.2)0

      5 most common events in each category listed in descending order of frequency across the 3 treatment arms. PT, preferred term; TRAE, treatment-related AE; imAE, immune-mediated AE.

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      In MYSTIC, results of OS analyses across most pt subgroups showed favourable HRs for D±T vs CT, consistent with the overall primary analysis. The safety profile of D±T was manageable and consistent with previous studies with lower rates of Grade ≥3 TRAEs reported compared to CT.

      b651e8a99c4375feb982b7c2cad376e9 Editorial acknowledgement

      Medical writing support, which was in accordance with Good Publication Practice (GPP3) guidelines, was provided by Samantha Holmes, PhD, of Cirrus Communications (Macclesfield, UK), an Ashfield company, and was funded by AstraZeneca.

      934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study

      AstraZeneca PLC.

      213f68309caaa4ccc14d5f99789640ad Funding

      AstraZeneca.

      682889d0a1d3b50267a69346a750433d Disclosure

      B.C. Cho: Grants/research support: Novartis, AstraZeneca, Yuhan, ONO/BMS, MSD, Bayer; Advisor/honoraria fees: AstraZeneca, Roche, Boehringer Ingelheim, Yuhan, BMS, MSD, Novartis; Speaker’s bureau fees: AZ, BMS, MSD, Novartis. N. Reinmuth: Personal fees: BMS, Roche, AstraZeneca, Takeda, Novartis, Boehringer Ingelheim, MSD, Lilly, outside the conduct of the study. A. Smolin: Grants: AstraZeneca; Grants, personal fees: AstraZeneca, Roche, MSD, BMS; Personal fees: BIOCAD, Boehringer Ingelheim. S.J. Antonia: Advisory boards/contracted research: Novartis; Advisory boards: BMS, Merck, CBMG, Boehringer Ingelheim, AstraZeneca, Memgen, FLX Bio, Nektar, Venn. G. Robinet: Grants, personal fees: AstraZeneca, MSD; Personal fees: Boehringer Ingelheim. R. Natale: Spouse employed (Medical Science Liaison): AstraZeneca - However, her salary and compensation is completely unrelated to the contracted research work performed at my institution for which I am a co-investigator. E.B. Garon: Research funding: Merck, Genentech, AstraZeneca, Novartis, Lilly, BMS, Mirati Therapeutics, Dynavax, Iovance Biotherapeutics.  K. Nakagawa: Research funding: GlaxoSmithKline K.K., AstraZeneca K.K., Kyowa Hakko Kirin, Pfizer Japan Inc., AbbVie Inc., Novartis Pharma K.K., Nippon Boehringer Ingelheim, Daiichi Sankyo, Eli Lilly Japan K.K., MSD K.K., Quintiles Inc., Ono Pharmaceutical, BMS, EPS International, Chugai Pharmaceutical, ICON Japan K.K., Gritstone Oncology, Inc., Linical, Yakult Honsha, PAREXEL International Corp., Otsuka Pharmaceutical, Astellas Pharma Inc., AC Medical Inc., Taiho Pharmaceutical, Merck Serono, EPS Associates, Quintiles Inc., Japan Clinical Research Operations, Eisai, PPD-SNBL K.K., Takeda Pharmaceutical, Covance Inc., inVentiv Health Japan, A2 Healthcare Corp., EP-CRSU; Honoraria: Astellas Pharma Inc., AstraZeneca K.K., Novartis Pharma K.K., Pfizer Japan Inc., Chugai Pharmaceutical, Ono Pharmaceutical, Nippon Boehringer Ingelheim, BMS, Kissei Pharmaceutical, Eli Lilly Japan K.K., MSD K.K., EPS Holdings Inc., Showa Yakuhin Kako, Clinical Trial, CareNet, Inc., Nikkei Business Publications, Inc., Nichi-Iko Pharmaceutical, Daiichi Sankyo, Taiho Pharmaceutical, AYUMI Pharmaceutical Corporation, Kyowa Hakko Kirin, Sym Bio Pharmaceuticals, Medicus Shuppan Publishers, Reno Medical K.K., Yodosha, Nanzando; Consulting or advisory role: Astellas Pharma Inc., Eli Lilly Japan K.K., Ono Pharmaceutical, Takeda Pharmaceutical. S. Peters: Personal fees: AbbVie, Amgen, AZ, Bayer, Biocartis, BI, BMS, Clovis, Daiichi Sankyo, Debiopharm, Eli Lilly, F. Hoffmann-La Roche, Foundation Medicine, Illumina, Janssen, MSD, Merck Serono, Merrimack, Novartis, Pharma Mar, Pfizer, Regeneron, Sanofi, Seattle Genetics, Takeda; Non-financial support: Amgen, AZ, BI, BMS, Clovis, F. Hoffmann-La Roche, Illumina, MSD, Merck Serono, Novartis, Pfizer. F. Liu, P. Thiyagarajah: Full-time employment: AstraZeneca. N.A. Rizvi: Advisory boards: AbbVie, AZ, BMS, EMD Serono, Genentech, GSK, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Neogenomics, Oncomed, Gritstone, Bellicum; Equity: Oncomed, Gritstone, Bellicum, ARMO; Royalties: PGDX (patent filed by MSKCC).  All other authors have declared no conflicts of interest.

      cffcb1a185b2d7d5c44e9dc785b6bb25

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      Invited Discussant LBA1_PR and LBA3 (ID 674)

      14:45 - 16:15  |  Presenting Author(s): Luis Paz-Ares

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      102O - Final analysis of the phase III KEYNOTE-042 study: Pembrolizumab (Pembro) versus platinum-based chemotherapy (Chemo) as first-line therapy for patients (Pts) with PD-L1–positive locally advanced/metastatic NSCLC (ID 542)

      14:45 - 16:15  |  Presenting Author(s): Tony S.K. Mok  |  Author(s): Yi-Long Wu, Iveta Kudaba, Dariusz M. Kowalski, Byoung Chul Cho, Hande Z. Turna, Gilberto de Castro Jr, Vichien Srimuninnimit, Konstantin K. Laktionov, Igor Bondarenko, Karou Kubota, Christian Caglevic, Boguslawa Karaszewska, Thao Dang, Lina Yin, Justina Penrod, Gilberto Lopes

      • Abstract
      • Presentation
      • Slides

      Background

      Pembro significantly improved OS vs chemo as first-line therapy in pts with PD-L1–positive locally advanced/metastatic NSCLC without EGFR/ALK alterations after median follow-up of 12.8 mo based on interim analysis of KEYNOTE-042 (NCT02220894). We present the final protocol-specified analysis with an additional 6 mo of follow-up.

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      Pts were randomized 1:1 to 35 cycles of pembro 200 mg Q3W or chemo (6 cycles of paclitaxel/pemetrexed [pem] + carboplatin with optional pem maintenance [nonsquamous only]), stratified by region (east Asia/non-east Asia), ECOG PS (0/1), histology (squamous/nonsquamous), and PD-L1 tumor proportion score (TPS; ≥50%/1%–49%). No α was allocated to OS in this analysis as the primary hypotheses for OS were met at the interim analysis. PFS differences (secondary endpoints) were assessed sequentially in pts with TPS ≥50%, ≥20%, and ≥1% using the stratified log-rank test (one-sided P = 0.01977, 0.02022, and 0.02065, respectively). Other secondary endpoints were ORR and safety. Duration of response (DOR) was an exploratory endpoint.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      1274 pts were randomized, 637 per arm. As of September 4, 2018 (median follow-up, 14 mo), 6% were receiving pembro and 3% were receiving pem maintenance. OS benefit with pembro vs chemo was maintained with longer follow-up (Table). PFS was not significantly improved with pembro vs chemo in pts with TPS ≥50%, therefore secondary efficacy hypotheses were not formally tested beyond TPS ≥50%. DOR was longer with pembro vs chemo (Table). Grade 3–5 treatment-related AEs were less frequent with pembro (18%) vs chemo (41%).

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      With an additional 6 mo follow-up, pembro demonstrated continued OS benefit vs chemo as first-line therapy in pts with locally advanced/metastatic PD-L1–positive NSCLC without EGFR/ALK alterations.

      b651e8a99c4375feb982b7c2cad376e9 Clinical trial identification

      NCT02220894.

      7a6a3ffa2dadc03a6151ee2c4d6fa383 Editorial acknowledgement

      Medical writing and editorial assistance was provided by Rozena Varghese, PharmD, of C4 MedSolutions, LLC (Yardley, PA), a CHC Group company. This assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

      934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study

      Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

      213f68309caaa4ccc14d5f99789640ad Funding

      Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

      682889d0a1d3b50267a69346a750433d Disclosure

      T.S.K. Mok: Grants or research support: AstraZeneca, Bristol-Myers Squibb, Clovis Oncology, Merck Sharp & Dohme, Novartis, Pfizer, Roche, SFJ Pharmaceuticals, XCovery; Speakers’ fees: AstraZeneca, Roche/Genentech, Pfizer, Eli Lilly, Boehringer Ingelheim, Merck Sharp & Dohme, Novartis, Bristol-Myers Squibb, Taiho, Takeda Oncology; Honoraria: AstraZeneca, Roche/Genentech, Pfizer, Eli Lilly, Boehringer Ingelheim, Merck Serono, Merck Sharp & Dohme, Novartis, SFJ Pharmaceuticals, ACEA Biosciences, Inc., Vertex Pharmaceuticals, Bristol-Myers Squibb, OncoGenex Pharmaceuticals, Inc., Celgene, Ignyta, Inc., Fishawack Facilitate Ltd, Takeda Oncology, Janssen; Major stockholder: Sanomics Ltd.; Advisory board member: AstraZeneca, Roche/Genentech, Pfizer, Eli Lilly, Boehringer Ingelheim, Clovis Oncology, Merck Serono, Merck Sharp & Dohme, Novartis, SFJ Pharmaceuticals, ACEA Biosciences, Inc., Vertex Pharmaceuticals, Bristol-Myers Squibb, geneDecode Co., Ltd., OncoGenex Technologies Inc., Celgene, Ignyta, Inc., Cirina, Fishawack Facilitate Ltd., Janssen, Takeda, ChiMed. Y-L. Wu: Honoraria: AstraZeneca, Eli Lilly, Roche, Pierre Fabre, Pfizer, Sanofi; Consulting, advisory role: AstraZeneca, Roche, Merck, Boehringer Ingelheim; Research funding to institution: Boehringer Ingelheim, Roche. B.C. Cho: Honoraria: AstraZeneca, Roche, Boehringer Ingelheim; Consultant/advisor: AstraZeneca, Roche, Boehringer Ingelheim; Speakers’ bureau: AstraZeneca, BMS, Merck Sharp & Dohme, Novartis; Research funding: Bayer, AstraZeneca, Yuhan, Novartis. G. de Castro Jr: Consulting, advisory role: AstraZeneca, MSD, BMS, Roche, Novartis, Boehringer Ingelheim; Speakers’ bureau: MSD, BMS, Novartis, AstraZeneca; Travel, accommodation, expenses: MSD, BMS, Roche, Bayer, Novartis, Boehringer Ingelheim, AstraZeneca. K. Kubota: Research funding: Boehringer Ingelheim, Taiho, Ono; Speakers’ fees: Chugai, Taiho, MSD, Boehringer Ingelheim, AstraZeneca, BMS, Eli-Lilly, Daiichi Sankyo, Novartis, Ono, Dainippon-Sumitomo, Kyowa-Kirin, Eisai; Advisory role: Taiho. C. Caglevic: Consultant/advisor: BMS, MSD, Bayer, AZ; Speakers’ bureau: BMS, MSD, Bayer, Lilly, Roche; Research funding: MSD, Boehringer Ingelheim, GSK, Bayer, AZ, Medivation, Astellas Pharma, BMS; Travel, accommodation expenses: Boehringer Ingelheim, MSD. T. Dang, L. Yin, J. Penrod: Employee: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. G. Lopes: Research funding to institution: Merck & Co., Inc., EMD Serono, AstraZeneca. All other authors have declared no conflicts of interest.

      cffcb1a185b2d7d5c44e9dc785b6bb25

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      103O_PR - Safety and efficacy of pembrolizumab (Pembro) monotherapy in elderly patients (Pts) with PD-L1&#x02013;positive advanced NSCLC: Pooled analysis from KEYNOTE-010, -024, and -042 (ID 466)

      14:45 - 16:15  |  Presenting Author(s): Kaname Nosaki  |  Author(s): Yukio Hosomi, Hideo Saka, Paul Baas, Giberto de Castro Jr, Martin Reck, Yi-Long Wu, Julie R. Brahmer, Enriqueta Felip, Takeshi Sawada, Kazuo Noguchi, Shi Rong Han, Bilal Piperdi, Debra A. Kush, Gilberto Lopes

      • Abstract
      • Presentation
      • Slides

      Background

      Approximately 70% of newly-diagnosed NSCLC cases occur in the elderly, and more than half are locally advanced/metastatic. We present a pooled analysis of efficacy and safety in elderly pts (aged ≥75 y) enrolled in 3 randomized controlled trials of pembro monotherapy vs standard chemotherapy (chemo) for PD-L1–positive advanced NSCLC.

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      Pts were aged ≥18 y with advanced NSCLC with PD-L1 tumor proportion score (TPS) ≥1% (KEYNOTE-010, -042) or TPS ≥50% (KEYNOTE-024). In KEYNOTE-010, pts were randomized to pembro 2 or 10 mg/kg Q3W or docetaxel, as second- or later-line therapy. In KEYNOTE-024 and -042, pts were randomized to first-line pembro 200 mg Q3W or platinum-based chemo. OS was estimated by the Kaplan-Meier method.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      The 3 trials included 264 pts aged ≥75 (range, 75–90) y with TPS ≥1%; 132 pts had TPS ≥50%. Independent of line of treatment, HRs (95% CI) for OS favored pembro vs chemo: 0.76 (0.56–1.02) in pts with TPS ≥1% and 0.40 (0.25–0.64) in pts with TPS ≥50%. Pembro also improved OS vs chemo in the pooled analysis of pts with TPS ≥50% who received first-line therapy (KEYNOTE-024 and -042): HR, 0.41 (95% CI, 0.23–0.73). Overall, fewer treatment-related AEs across various categories were observed with pembro vs chemo, in particular, grade 3–5 treatment-related AEs in pts aged ≥75 y (Table). Immune-mediated AEs and infusion reactions were more frequent with pembro vs chemo, with similar frequency in pts receiving pembro aged ≥75 y and <75 y (Table).

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      In this pooled analysis of pts aged ≥75 y with PD-L1–positive advanced NSCLC, pembro monotherapy improved OS vs chemo, both in pts with PD-L1 TPS ≥1% and PD-L1 TPS ≥50%. The safety profile of pembro was similar in pts aged ≥75 y and <75 y, with lower rates of grade 3–5 treatment-related AEs vs chemo.

      b651e8a99c4375feb982b7c2cad376e9 Clinical trial identification

      NCT01905657 (KEYNOTE-010); NCT02142738 (KEYNOTE-024); NCT02220894 (KEYNOTE-042).

      7a6a3ffa2dadc03a6151ee2c4d6fa383 Editorial acknowledgement

      Medical writing and editorial assistance was provided by Michael S. McNamara, MS, of C4 MedSolutions, LLC (Yardley, PA), a CHC Group company and funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

      934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study

      Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

      213f68309caaa4ccc14d5f99789640ad Funding

      Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

      682889d0a1d3b50267a69346a750433d Disclosure

      K. Nosaki: Honoraria: AstraZeneca, Chugai Pharmaceutical, Eli Lilly, MSD; Institutional research funding: MSD. Y. Hosomi: Personal fees: MSD, AstraZeneca, Eli Lilly Japan, Taiho Pharmaceutical, Chugai Pharmaceutical, Ono Pharmaceutical, Bristol-Myers Squibb. H. Saka: Grants/research support: AstraZeneca, MSD, Ono Pharmaceutical; Honoraria: AstraZeneca, MSD, Ono Pharmaceutical, Chugai Pharmaceutical, Boehringer Ingelheim, Kyorin Pharmaceutical. P. Baas: Consulting role: Genentech/Roche, Merck, Bristol-Myers Squibb, Pfizer; Research support: Bristol-Myers Squibb, Roche, Merck. G. de Castro Jr: Consulting/advisory role: AstraZeneca, MSD, BMS, Roche, Novartis, Boehringer Ingelheim; Speakers’ bureau: MSD, BMS, Novartis, AstraZeneca; Travel/accommodation expenses: MSD, BMS, Roche, Bayer, Novartis, Boehringer Ingelheim, AstraZeneca. M. Reck: Personal fees: Amgen, Hoffmann-La Roche, Lilly, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, MSD, Merck, Novartis, Pfizer, AbbVie. Y-L. Wu: Honoraria: AstraZeneca, Eli Lilly, Roche, Pierre Fabre, Pfizer, Sanofi; Consulting/advisory role: AstraZeneca, Roche, Merck, Boehringer Ingelheim; Research funding to institution: Boehringer Ingelheim, Roche. J.R. Brahmer: Grant, personal fees, Advisory boards, consulting: Merck; Uncompensated advisor and consultant: Bristol-Myers Squibb; Grants: Bristol-Myers Squibb, MedImmune/AstraZeneca; Personal fees: Amgen, Celgene, Lilly. E. Felip: Consulting, advisory role, speaker’s bureau: AbbVie, AstraZeneca, Blueprint Medicines, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Guardant Health, Janssen, Merck KGaA, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Takeda; Research funding: Fundación Merck Salud; Grant for Oncology Innovation EMD Serono. T. Sawada, K. Noguchi, S.R. Han: Employee: MSD K.K., Tokyo, Japan. B. Piperdi, D.A. Kush: Employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. G. Lopes: Research funding to institution: Merck & Co., Inc., EMD Serono, AstraZeneca.

      cffcb1a185b2d7d5c44e9dc785b6bb25

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      Invited Discussant 102O and 103O_PR (ID 675)

      14:45 - 16:15  |  Presenting Author(s): Sanjay Popat

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    Genetic heterogeneity and clonal evolution (ID 32)

    • Event: ELCC 2019
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      Clonal evolution in lung cancer (ID 84)

      10:30 - 12:00  |  Presenting Author(s): Nicholas McGranahan

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      Immune microenvironment and cancer evolution (ID 83)

      10:30 - 12:00  |  Presenting Author(s): Michael Hölzel

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      Elucidating EGFR evolution (ID 82)

      10:30 - 12:00  |  Presenting Author(s): Daniel Shao Weng Tan

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      Challenges in tracking clonal evolution (ID 85)

      10:30 - 12:00  |  Presenting Author(s): Martin Peifer

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  • +

    HHH Award lecture (ID 5)

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      The HHH model applied to radiotherapy: Honour the past, evaluate the present and stimulate the future (ID 76)

      13:45 - 14:15  |  Presenting Author(s): Françoise Mornex

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      I-O monotherapy (ID 33)

      09:00 - 10:30  |  Presenting Author(s): Martin Reck

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      Combo I-O/Chemo (ID 34)

      09:00 - 10:30  |  Presenting Author(s): Luis Paz-Ares

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      Combo I-O/I-O (ID 35)

      09:00 - 10:30  |  Presenting Author(s): Solange Peters

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      Predictive diagnostics and treatment algorithms (ID 36)

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      Microbiome in cancer immunotherapy (ID 58)

      14:10 - 14:40  |  Presenting Author(s): Laurence Zitvogel

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      Do we need a molecular board in our hospital? (ID 93)

      14:30 - 16:00  |  Presenting Author(s): Mark G. Kris

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      Biomarkers are a rapidly changing scenario: How to face it (ID 94)

      14:30 - 16:00  |  Presenting Author(s): Egbert F. Smit

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      Facts and myths of liquid biopsy (ID 95)

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    Multiple lung tumour nodules (ID 25)

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      Treatment options from the medical oncologist's perspective (ID 69)

      16:45 - 17:45  |  Presenting Author(s): Jon Zugazagoitia

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      Surgical decision: To operate or not to operate? (ID 70)

      16:45 - 17:45  |  Presenting Author(s): Tetsuya Mitsudomi

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      The role of the pathologist: Multiple primaries vs metastatic disease (ID 71)

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    My patient has stage IIIA (N2) disease: Surgery or radiotherapy? (ID 1)

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      Case presentation (ID 1)

      14:30 - 16:00  |  Presenting Author(s): Miklos Pless

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      My patient needs neoadjuivant treatment followed by surgery (ID 2)

      14:30 - 16:00  |  Presenting Author(s): Wilfried Ernst Erich Eberhardt

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      My patient needs surgery upfront followed by adjuvant treatment (ID 3)

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      My patient needs chemoradiotherapy and durvalumab (ID 4)

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