All times are listed in CEST (Central European Summer Time)
- Rafal Dziadziuszko (Gdansk, Poland)
- Fiona Blackhall (Manchester, United Kingdom)
1261O - Neoadjuvant nivolumab (N) + ipilimumab (I) vs chemotherapy (C) in the phase III CheckMate 816 trial
- Mark M. Awad (Boston, United States of America)
Abstract
Background
The phase 3 CheckMate 816 trial met both of its primary endpoints, with neoadjuvant N + C demonstrating statistically significant and clinically meaningful improvements in event-free survival (EFS) and pathological complete response (pCR) vs C in patients (pts) with resectable NSCLC; N + C continues to show long-term EFS benefit vs C. Here, we report exploratory analyses from the concurrently randomized N + I and C arms of the study.
Methods
Adults with stage IB (≥ 4 cm)–IIIA (per AJCC 7th ed) resectable NSCLC, ECOG PS ≤ 1, and no known
Results
In the concurrently randomized N + I (n = 113) and C (n = 108) arms, BL characteristics were generally balanced between treatment (tx) arms. At a median follow-up of 49.2 mo (database lock, 14 Oct 2022), both EFS and OS appeared to favor N + I vs C. Median EFS was 54.8 mo vs 20.9 mo with N + I vs C (HR 0.77 [95% CI 0.51–1.15]; 3-y EFS rates, 56% vs 44%). Median OS was not reached in either tx arm (HR 0.73 [95% CI 0.47–1.14]; 3-y OS rates, 73% vs 61%). pCR rate (95% CI) was higher with N + I vs C (20% [13.4–29.0] vs 5% [1.5–10.5]). Definitive surgery occurred for 74% and 76% of pts in the N + I and C arms, respectively; R0 resection rates were 80% and 71%. A high vs low BL 4-gene inflammatory score was associated with improved EFS and pCR with N + I. Grade 3–4 tx-related adverse events (AEs) and grade 3–4 surgery-related AEs were reported in 14% vs 36% and 15% vs 14% of pts in the N + I and C arms, respectively. Outcomes in key subgroups, including by PD-L1 expression, will be presented.
Conclusions
These exploratory analyses from CheckMate 816 showed potential clinical benefit and a manageable safety profile with neoadjuvant N + I vs C; N + C remains the standard neoadjuvant treatment for pts with resectable NSCLC, as previously reported.
Clinical trial identification
NCT02998528.
Editorial acknowledgement
Editorial assistance in the writing of the abstract was provided by Christine Billecke, PhD, and Michele Salernitano of Ashfield MedComms, an Inizio company.
Legal entity responsible for the study
Bristol Myers Squibb.
Funding
Bristol Myers Squibb.
Disclosure
M.M. Awad: Financial Interests, Personal, Speaker, Consultant, Advisor: Genentech, Bristol Myers Squibb, Merck, AstraZeneca, Maverick, Blueprint Medicine, Syndax, Ariad, Nektar, ArcherDX, Mirati, NextCure, Novartis, EMD Serono; Financial Interests, Institutional, Research Funding: AstraZeneca, Lilly, Genentech, Bristol Myers Squibb. P.M. Forde: Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, BMS, Daiichi, F-Star, G1, Genentech, Iteos, Janssen, Merck, Novartis, Sanofi, Surface.; Financial Interests, Institutional, Research Funding: AstraZeneca, BioNTech, BMS, Corvus, Kyowa, Novartis, and Regeneron and trial steering committee membership for AstraZeneca, Biontech, BMS, Corvus; Financial Interests, Personal, Member of Board of Directors: Mesothelioma Applied Research Foundation; Non-Financial Interests, Personal, Advisory Board: LUNGevity. N. Girard: Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, MSD, Roche, Pfizer, Mirati, Amgen, Novartis, Sanofi, Gilead; Financial Interests, Personal, Advisory Board: AstraZeneca, BMS, MSD, Roche, Pfizer, Janssen, Boehringer, Novartis, Sanofi, AbbVie, Amgen, Lilly, Grunenthal, Takeda, Owkin, Leo Pharma, Daiichi Sankyo, Ipsen; Financial Interests, Institutional, Research Grant, Local: Roche, Sivan, Janssen; Financial Interests, Institutional, Funding: BMS, Leo Pharma; Financial Interests, Institutional, Research Grant: MSD; Non-Financial Interests, Officer, International Thymic malignancy interest group, president: ITMIG; Other, Family member is an employee: AstraZeneca. J.D. Spicer: Financial Interests, Institutional, Research Grant: AstraZeneca, BMS, CLS Therapeutics, Protalix Biotherapeutics, Merck, Roche; Financial Interests, Personal, Speaker, Consultant, Advisor: Roche, Merck, BMS, AstraZeneca, Regeneron, Protalix Biotherapeutics, Xenetic Biosciences, Amgen, Novartis; Financial Interests, Personal, Financially compensated role: PeerView, BMS, AstraZeneca; Non-Financial Interests, Personal, Advisory Board: PUCC trial, Industry chair for Canadian Association of Thoracic Surgeons. C. Wang: Financial Interests, Personal, Advisory Board: Bristol Myers Squibb; Financial Interests, Personal, Leadership Role, Vice Chairmen of Oncology committee - National Health Commission Capacity Building and Continuing Education: Vice Chairmen of CSCO-Lung. S. Lu: Financial Interests, Institutional, Invited Speaker: Hansoh, AstraZeneca, Roche, Hengrui; Financial Interests, Institutional, Advisory Board: AstraZeneca, Pfizer, Boehringer lngelheim, Hutchison MediPharma, ZaiLab, GenomiCare, Yuhan Corporation, Menarini, InventisBio Co.Ltd, Roche, Simcere Zaiming Pharmaceutical Co., Ltd.; Financial Interests, Research Grant: AstraZeneca, Hutchison, BMS, Heng Rui, Roche, Hansoh, BeiGene, Lilly Suzhou Pharmaceutical Co. Ltd; Financial Interests, Coordinating PI: FibroGen. T. Mitsudomi: Financial Interests, Personal, Invited Speaker: AstraZeneca, Chugai, Novartis, MSD, Ono, Pfizer, Amgen, Takeda, Eli Lilly, Merck Biopharma, Bayer; Financial Interests, Personal, Advisory Board: AstraZeneca, Boehringer Ingelheim, Ono, Janssen; Financial Interests, Institutional, Local PI: Boehringer Ingelheim, Chugai, MSD, Taiho, Daiichi Sankyo, Ono; Financial Interests, Institutional, Coordinating PI: AstraZeneca; Non-Financial Interests, Leadership Role, Past President of International Association of Study for Lung Cancer: IASLC; Non-Financial Interests, Leadership Role: International Association for Study of Lung Cancer. E. Felip: Financial Interests, Personal, Advisory Board: AbbVie, Amgen, AstraZeneca, Bayer, BeiGene, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, F. Hoffmann-La Roche, Gilead, GSK, Janssen, Merck Serono, Merck Sharp & Dohme, Novartis, Peptomyc, Regeneron, Sanofi, Takeda, Turning Point, Pfizer; Financial Interests, Personal, Invited Speaker: Amgen, Daiichi Sankyo, Genentech, Janssen, Medical Trends, Medscape, Merck Serono, PeerVoice, Pfizer, Sanofi, Takeda, Touch Oncology, AstraZeneca, Bristol Myers Squibb, Eli Lilly, F. Hoffmann-La Roche, Merck Sharp & Dohme; Financial Interests, Personal, Member of Board of Directors, Independent member: Grifols; Financial Interests, Institutional, Local PI, Clinical Trial: AstraZeneca AB, AbbVie, Amgen, Bayer Consumer Care AG, BeiGene, Boehringer Ingelheim GmbH, Bristol Myers Squibb International Corporation, Daiichi Sankyo Inc., Exelixis Inc., F. Hoffmann-La Roche Ltd., Genentech Inc., GSK Research and Development Limited, Janssen Cilag International NV, Merck Sharp & Dohme Corp, Merck KGAA, Mirati Therapeutics Inc, Novartis Pharmaceutica SA, Pfizer, Takeda Pharmaceuticals International; Non-Financial Interests, Leadership Role, President (2021-2023): SEOM (Sociedad Espanola de Oncologia Medica); Non-Financial Interests, Member, Member of Scientific Committee: ETOP (European Thoracic Oncology Platform); Non-Financial Interests, Member, Member of the Scientiffic Advisory Committee: CAC Hospital Universitari Parc Taulí. S. Broderick: Financial Interests, Personal, Advisory Board: AstraZeneca. S.J. Swanson: Financial Interests, Personal, Speaker’s Bureau: Ethicon. J.R. Brahmer: Financial Interests, Institutional, Research Grant: Bristol Myers Squibb, AstraZeneca; Financial Interests, Personal, Speaker, Consultant, Advisor: Bristol Myers Squibb, AstraZeneca, Merck, Regeneron; Financial Interests, Personal, Invited Speaker: Bristol Myers Squibb; Financial Interests, Personal, Advisory Board: Johnson and Johnson, Sanofi, GSK, LUNGevity Lung Cancer Research Foundation, Lung Cancer Foundation of America Scientific Advisory Board Member; Financial Interests, Personal, Member of Board of Directors: Society for the Immunotherapy of Cancer (SITC) Board Member. K.M. Kerr: Financial Interests, Personal, Advisory Board, Consultancy: AbbVie, Amgen, AstraZeneca, Bayer, Debiopharm, Diaceutics, Merck Serono, Merck Sharp & Dohme, Novartis, Pfizer, Regeneron, Roche, Roche Diagnostics/Ventana, Jannsen; Financial Interests, Personal, Invited Speaker: AstraZeneca, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Merck Serono, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Roche Diagnostics/Ventana, Medscape, Prime Oncology; Non-Financial Interests, Leadership Role, Past Pathology Committee Chair: IASLC; Non-Financial Interests, Member, Lobbying and pressure group for UK - generally writing reports to lobby government: UK Lung Cancer Consortium. J.L. Cai: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. J. Neely: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. D. Balli: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. N. Hu: Financial Interests, Institutional, Full or part-time Employment: Bristol Myers Squibb. M. Provencio Pulla: Financial Interests, Personal, Advisory Board: BMS, MSD, Bayer, Lilly, Roche, Takeda, Janssen; Non-Financial Interests, Leadership Role, President of Spanish Lung cancer Group: President; Non-Financial Interests, Leadership Role, Insutituto Investigación Sanitaria Puerta de Hierro: Director. All other authors have declared no conflicts of interest.
LBA56 - Overall survival in the KEYNOTE-671 study of perioperative pembrolizumab for early-stage non-small-cell lung cancer (NSCLC)
- Jonathan D. Spicer (Montreal, Canada)
Abstract
Background
At the protocol-specified first interim analysis of the phase 3 KEYNOTE-671 study of resectable early-stage NSCLC (NCT03425643), neoadjuvant pembrolizumab (pembro) + chemotherapy (chemo) followed by resection and adjuvant pembro significantly improved EFS, mPR, and pCR with an expected safety profile vs neoadjuvant chemo and resection alone. We present results of the protocol-specified second interim analysis of KEYNOTE-671.
Methods
Patients (pts) with resectable stage II, IIIA, or IIIB (N2) NSCLC per AJCC v8 were randomized 1:1 to pembro 200 mg (n = 397) or placebo (n = 400) Q3W. Pts were to receive 4 cycles of neoadjuvant pembro or placebo plus cisplatin-based chemo and ≤13 cycles of adjuvant pembro or placebo. Dual primary endpoints are EFS (time from randomization to local progression precluding planned surgery, unresectable tumor, progression or recurrence per RECIST v1.1 by investigator assessment, or death from any cause) and OS.
Results
Median time from randomization to the 10 July 2023 data cutoff was 36.6 mo (range, 18.8-62.0). With 254 (31.9%) deaths, OS was significantly improved in the pembro arm (HR 0.72 [95% CI 0.56-0.93];
Conclusions
Neoadjuvant pembro + chemo followed by resection and adjuvant pembro provided a statistically significant and clinically important improvement in OS compared with neoadjuvant chemo and resection alone in pts with resectable stage II, IIIA, or IIIB (N2) NSCLC. The OS gains seen in KEYNOTE-671 with the absence of new safety signals establish the perioperative pembro regimen as a new standard of care for resectable early-stage NSCLC.
Clinical trial identification
NCT03425643, first posted February 7, 2018.
Editorial acknowledgement
Editorial assistance provided by Melanie A. Leiby, PhD, an employee of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Legal entity responsible for the study
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Funding
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Disclosure
J.D. Spicer: Financial Interests, Personal, Advisory Role, honoraria: AstraZeneca, Merck & Co., Inc., Rahway, NJ, USA, Bristol-Myers Squibb, Amgen, Chemocentryx, Regeneron, Protalix Biotherapeutics, Xenetic Biosciences, Novartis; Financial Interests, Institutional, Funding: AstraZeneca, Merck Sharp & Dohme Corp., Bristol-Myers Squibb, CLS Therapeutics, Protalix Biotherapeutics. S. Gao: Financial Interests, Institutional, Funding, To support study conduct: Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.. M. Liberman: Financial Interests, Personal, Advisory Board: Johnson & Johnson; Financial Interests, Personal, Stocks/Shares, CMO: Endocision, AssistIQ, Ditch Labs; Financial Interests, Local PI: Merck, AstraZeneca, Pfizer, BMS; Financial Interests, Research Grant: J&J. T. Kato: Financial Interests, Personal, Advisory Board, speaker, consultancy: AstraZeneca, Eli Lilly, Merck Biopharma, MSD; Financial Interests, Personal, Advisory Board, speaker: Pfizer, Amgen, Janssen; Financial Interests, Personal, Other, consultancy: Daiichi Sankyo, Takeda, Taiho; Financial Interests, Personal, Other, consultancy, speaker: Chugai; Financial Interests, Personal, Invited Speaker: Ono, Novartis, Bristol-Meyers Squibb, Boehringer Ingelheim; Financial Interests, Personal, Advisory Board: Beigene, Glaxo; Financial Interests, Personal, Advisory Board, Steering Committee: Roche; Financial Interests, Personal, Full or part-time Employment, Family member: Eli Lilly; Financial Interests, Institutional, Local PI: Chugai, MSD, Pfizer, Eli Lilly, AbbVie, Regeneron, Novartis, Amgen, Merck Biophama, BeiGene, Haihe Biopharma, Blueprint Medicines, Turning Point, Takeda, Daiichi Sankyo, Gilead, GSK, Janssen, Bayer; Financial Interests, Institutional, Steering Committee Member, Local PI: AstraZeneca. M. Tsuboi: Financial Interests, Personal, Invited Speaker, Lecture: Johnson & Johnson Japan; Financial Interests, Personal, Advisory Board, Lectures, Advisory boards: AstraZeneca KK, Chugai Pharmaceutical Co.,Ltd, MSD; Financial Interests, Personal, Invited Speaker, Lectures: Eli Lilly Japan, Bristol-Myers Squibb KK, Taiho Pharma, Medtronic Japan, ONO Pharmaceutical CO.,LTD, Daiichi Sankyo company limited; Financial Interests, Personal, Advisory Board, Advisory boards: Novartis, MiREXS; Financial Interests, Institutional, Research Grant: Beohringer-Ingelheim Japan, MSD, AstraZeneca KK, Ono Pharmaceutical Co.,Ltd, Bristol-Myers Squibb KK, Novartis, MiRXES; Financial Interests, Personal, Steering Committee Member: MSD, AstraZeneca, Novartis; Financial Interests, Institutional, Steering Committee Member: Eli Lilly Japan. S. Lee: Financial Interests, Personal, Advisory Board: AstraZeneca/MedImmune, Roche, Merck, Pfizer, Lilly, BMS/Ono, Takeda, Janssen, IMBdx; Financial Interests, Personal, Invited Speaker: AstraZeneca/MedImmune, Roche, Merck, Lilly, Amgen; Financial Interests, Institutional, Research Grant: Merck, AstraZeneca, Lunit. K. Chen: Financial Interests, Institutional, Funding, Supports study conduct: MSD. M. Majem: Financial Interests, Personal, Advisory Board: Amgen, Roche, AstraZeneca,Takeda, Janssen, Cassen Recordati, BMS; Financial Interests, Personal, Invited Speaker: Amgen, Roche, AstraZeneca, Pfizer, Takeda, Helsinn; Financial Interests, Institutional, Funding: BMS, AstraZeneca, Roche. E. Eigendorff: Financial Interests, Institutional, Funding, Studying funding to the institution to support study conduct: MSD. G. Martinengo: Financial Interests, Institutional, Funding, Funding to institution to suport study conduct: MSD. O. Bylicki: Financial Interests, Personal, Advisory Board, Expert Board: BMS, Roche, Takeda; Financial Interests, Personal, Advisory Board, Annuel contrat: MSD; Financial Interests, Personal, Advisory Board, expert board: AstraZeneca, janssen. M.C. Garassino: Financial Interests, Personal, Advisory Board: Eli Lilly, SeaGen International GmbH, Eli Lilly, Incyte, GSK, Bayer Healthcare Pharmaceuticals, Blueprint Medicines, AstraZeneca UK, AstraZeneca and Daiichi Sankyo Oncology Teams, Roche, Daiichi Sankyo, Mirati Therapeutics, Inc, Daiichi Sankyo/AstraZeneca, AstraZeneca Poland, Daiichi Sankyo, Inc., MSD, Eli Lilly, Pfizer, AstraZeneca/MedImmune, Sanofi Genzyme corporation, Sanofi / Prex, Regeneron Pharmaceuticals, Eli Lilly, Mirati Therapeutics, Inc.; Financial Interests, Personal, Invited Speaker: WebMD, WebMD Oncology/Takeda, MSD Italia, Srl, GrupoPacifico-Secretaria Técnica ICAPEM/AstraZeneca, S.O.S S.r.l, Medscape, ecancer, Ideology; Financial Interests, Personal, Invited Speaker, Global Experts Meeting: AstraZeneca; Financial Interests, Personal, Other, AstraZeneca Spain: Invitation to a lung cancer investigator meeting: AstraZeneca; Financial Interests, Personal, Advisory Board, Advisory Boards: Takeda, Daiichi Sankyo, BeiGene; Financial Interests, Personal, Other, PACIFIC-R Global Scientific Committee: AstraZeneca; Financial Interests, Personal, Other, Steering Committee member and Co-chair at the AstraZeneca Lung Cancer Summit 2019: AstraZeneca; Financial Interests, Personal, Other, MK-3475 KN671 Steering Committee.: MSD; Financial Interests, Personal, Other, Pacific 6 International Coordinating Investigator: AstraZeneca; Financial Interests, Personal, Other, Janssen Scientific Advisory Board and Therapeutic Area Steering Committee Meeting on Lung Cancer: Janssen; Financial Interests, Personal, Other, Pfizer Global Lung Cancer Educational Programme - Steering Committee: Pfizer; Financial Interests, Personal, Other, Seattle Genetics Lung Cancer Platform Study: Seattle Genetics; Financial Interests, Personal, Other, GSK Lung Cancer Global Council: GSK; Financial Interests, Personal, Other, PACIFIC-R Scientific Committee: AstraZeneca UK; Financial Interests, Personal, Other, GSK-Garassino- ZEAL Steering Committee 2020-23: GSK; Financial Interests, Personal, Advisory Board, Advisory Board: AbbVie, Abion, Bayer; Financial Interests, Personal, Invited Speaker, Satellite Symposium: merck; Financial Interests, Personal, Advisory Board, Advisory boards: Merck, Sanofi, Gilead; Financial Interests, Personal, Invited Speaker, Invited speaker: Medscape; Financial Interests, Personal, Advisory Board, Invited speaker: OncoHost; Financial Interests, Personal, Advisory Board, Advisor: Boheringer; Financial Interests, Personal, Steering Committee Member, Member of the MK-3475 KN671 Steering Committee (KEYNOTE-671): MSD; Financial Interests, Personal, Coordinating PI, Coordinating investigator for the MK-3475 KEYNOTE 189: MSD; Financial Interests, Personal and Institutional, Coordinating PI, Pacific 6 Steering Committee and International Coordinating Investigator: AstraZeneca; Financial Interests, Institutional, Steering Committee Member, Steering Committee ML41118 Roche: Roche; Financial Interests, Institutional, Local PI, TURNING POINT: Bayer; Financial Interests, Institutional, Local PI, Phase II: Celgene Corporation, Spectrum Pharmaceuticals, Merk Serono; Financial Interests, Institutional, Local PI, A Phase 1: Janssen; Financial Interests, Institutional, Local PI, Array 818-202: Pfizer; Financial Interests, Institutional, Local PI, PAPILLON Study: Janssen; Financial Interests, Institutional, Local PI: Amgen; Financial Interests, Institutional, Local PI, Phase 3: Bluprint; Financial Interests, Institutional, Local PI, Phase 3 Study RESILIENT: IPSEN Bioscience Inc.; Financial Interests, Institutional, Local PI, Phase III: Amgen, GSK Research & Develpoment Ltd., Novartis; Financial Interests, Institutional, Local PI, Phase III - CEACAM5: Sanofi; Financial Interests, Institutional, Local PI, Phase I-JNJ-61186372, a Human Bispecific EGFR and cMet Antibody: Janssen; Financial Interests, Institutional, Local PI, Phase II - SAVANNAH: AstraZeneca S.p.A.; Financial Interests, Institutional, Local PI, phase III NEOCOAST: MedImmune LCC; Financial Interests, Institutional, Local PI, Phase II - coast: MedImmune LCC; Financial Interests, Institutional, Local PI, Phase III - ADRIATIC: AstraZeneca; Financial Interests, Institutional, Local PI, Phase III (CANOPY-1): Novartis; Financial Interests, Institutional, Local PI, Phase 1b: Exelixis Inc.; Financial Interests, Institutional, Local PI, Phase 3-GO40241: Roche; Financial Interests, Institutional, Local PI, Phase III- CASPIAN: AstraZeneca; Financial Interests, Institutional, Local PI, Phase III CA209-017: BMS; Financial Interests, Institutional, Local PI, MK3475-091 - PEARLS: Merk; Financial Interests, Institutional, Local PI, Phase III - Roche GO29431: Roche; Financial Interests, Institutional, Local PI, Phase III - ARCTIC: AstraZeneca; Financial Interests, Institutional, Local PI, Phase III - AURA 3: AstraZeneca AB; Financial Interests, Institutional, Local PI, Phase III CA209-057: BMS; Financial Interests, Institutional, Local PI, OPEL/2014/14/067: Otsuka Pharmaceutical Italy S.r.l.; Financial Interests, Institutional, Local PI, Phase II - VISION: Merck KGaA; Financial Interests, Institutional, Local PI, Phase III MK-3475-715: Incyte Corporation; Financial Interests, Institutional, Local PI, Phase 1/2 (TRIDENT-1): Turning Point Therapeutics, Inc.; Financial Interests, Institutional, Local PI, HERTHENA-Lung01: A Phase 2: Daiichi Sankyo Development Ltd.; Financial Interests, Institutional, Local PI, Phase II ATLANTIC: AstraZeneca S.p.A.; Financial Interests, Institutional, Local PI, Clinical trial: Affimed; Financial Interests, Institutional, Local PI, Clinical trial poziotinib: spectrum; Non-Financial Interests, Principal Investigator, STYLE Trial: Pfizer; Non-Financial Interests, Principal Investigator, Studio TYME: Eli Lilly; Non-Financial Interests, Principal Investigator, People: MSD; Non-Financial Interests, Principal Investigator, FAME trial: Istituto Nazionale dei Tumori; Non-Financial Interests, Principal Investigator, POST-ALK: Istituto Nazionale dei Tumori; Non-Financial Interests, Principal Investigator, Bando finalizzata Mesotelioma: Istituto Nazionale dei Tumori; Non-Financial Interests, Principal Investigator, TERAVOLT: Istituto Nazionale dei Tumori; Non-Financial Interests, Principal Investigator, IND227: Istituto dei Tumori Pascale - Napoli; Non-Financial Interests, Principal Investigator, Progetto Timoma: Istituto Nazionale dei Tumori; Non-Financial Interests, Principal Investigator, APOLLO: Istituto Nazionale dei Tumori; Non-Financial Interests, Principal Investigator, Beverly: Istituto dei Tumori Pascale - Napoli; Non-Financial Interests, Principal Investigator, RAMES: GOIRC; Non-Financial Interests, Principal Investigator, Studio CHANCE: GOIRC; Non-Financial Interests, Principal Investigator, Creta trial: Sant'Orsola Malpighi - Bologna (Alma Mater Studiorum Università Bologna); Non-Financial Interests, Principal Investigator, MILES 5: Istituto dei Tumori Pascale - Napoli; Non-Financial Interests, Principal Investigator, LIPI: GUSTAVE-ROUSSY PARIGI LIPI TRIAL- no profit; Non-Financial Interests, Principal Investigator: AO Spedali Civili Brescia; Non-Financial Interests, Principal Investigator, phase III trial: European Thoracic Oncology Platform (ETOP); Non-Financial Interests, Leadership Role, Honorary President and Founder: Women for Oncology Italy; Non-Financial Interests, Other, Member of ASCO Scientific Committee (2018-2021): ASCO; Non-Financial Interests, Leadership Role, Board member: AIOT (Associazione Italiana Oncologia Toracica); Non-Financial Interests, Member: AIOM, AIOT; Non-Financial Interests, Member, WCLC annual congress Lung Cancer Track: WCLC; Non-Financial Interests, Member, Scientific Committee: IPOP (Italian lung cancer charity), TUTOR (Italian thymic malignancies charity); Non-Financial Interests, Member, Member since 2013-2018: EMA Scientific Advisory Group (SAG); Non-Financial Interests, Other, Scientific Programme Committee: AACR; Non-Financial Interests, Leadership Role, previous ESMO National Societies Committee Chair and ESMO Council Member: ESMO; Other, Travel, Accommodations, Expenses: Pfizer; Other, Relationships to Disclose Travel, Accommodations, Expenses: Roche, AstraZeneca; Other, travel and accomodation: Merk. D. Rodriguez Abreu: Financial Interests, Personal, Advisory Board: MSD, Novartis, Roche/Genentech, pfizer, Bristol-Myers Squibb, AstraZeneca, Regeneron, Gilead, Sanofi, Amgen, Takeda, Eli Lilly, Incyte, Merck Serono; Financial Interests, Personal, Invited Speaker: MSD, Novartis, Roche/Genentech, pfizer, Bristol-Myers Squibb, AstraZeneca, Regeneron, Gilead, Sanofi, Amgen, Takeda, Eli Lilly, Merck Serono; Financial Interests, Personal, Other, Travel expenses: MSD, Novartis, Roche/Genentech, pfizer. J. Chaft: Other, Personal, Speaker, Consultant, Advisor: arcus biosciences, AstraZeneca, Bristol Myers Squibb Company, Flame biosciences, Guardant Health, Merck, Regeneron Pharmaceuticals; Financial Interests, Institutional, Funding, Funding to support study conduct: Merck Sharp & Dohme; Financial Interests, Institutional, Funding, Funded by Cancer Center Support Grant P30 CA008748: NIH. S. Novello: Financial Interests, Personal, Invited Speaker: AstraZeneca, MSD, Eli Lilly, Novartis, Beigene, Amgen; Financial Interests, Personal, Advisory Board: BI, BMS, Pfizer, Takeda, Roche, Sanofi, Amgen; Financial Interests, Institutional, Coordinating PI, IIT: MSD, BI; Non-Financial Interests, Leadership Role, president of this european advocacy: WALCE. J. Yang: Financial Interests, Personal, Full or part-time Employment: Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.. S.M. Keller: Financial Interests, Personal, Full or part-time Employment: Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.; Financial Interests, Personal, Stocks/Shares: Merck & Co., Inc.. A. Samkari: Financial Interests, Personal, Full or part-time Employment: Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.; Financial Interests, Personal, Stocks/Shares: Merck & Co., Inc.. H. Wakelee: Financial Interests, Personal, Advisory Board, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Blueprint, Mirati; Financial Interests, Personal, Invited Speaker, Develop and present a series of lectures: Fishawack Facilitate LTD; Financial Interests, Personal, Invited Speaker, Series of CME lectures: Medscape, Research to Practice; Financial Interests, Personal, Other, Discussion of new data at conferences: Curio Science; Financial Interests, Personal, Invited Speaker, Series of lectures/webinars for PER/OncLive: MJH Holdings; Financial Interests, Personal, Writing Engagement: UpToDate; Financial Interests, Personal, Invited Speaker, CME lecture: Axis Medical Education, Nexus Oncology; Financial Interests, Institutional, Local PI, Clinical Trial Conduct: ACEA Biosciences, Arrys Therapeutics, AstraZeneca/Medimmune, BMS, Clovis Oncology, Novartis, Seagen, Xcovery; Financial Interests, Institutional, Coordinating PI, Clinical Trial Conduct: Celgene; Financial Interests, Institutional, Steering Committee Member, Clinical Trial Conduct: Genentech/Roche, Merck; Non-Financial Interests, Leadership Role, Executive Committee: ECOG-ACRIN; Financial Interests, Institutional, Local PI, clinical trial conduct: Helsinn; Non-Financial Interests, Officer, President: International Association for the Study of Lung Cancer (IASLC). All other authors have declared no conflicts of interest.
Invited Discussant 1261O and LBA56
- Jarushka Naidoo (Dublin, Ireland)
Q&A
- All Speakers (Lugano, Switzerland)
LBA60 - Stereotactic body radiation therapy with sequential immunochemotherapy as neoadjuvant therapy in resectable non-small cell lung cancer
- Ze-rui Zhao (Guangzhou, China)
Abstract
Background
Phase 3 trials of neoadjuvant immunochemotherapy in patients with resectable non-small-cell lung cancer (NSCLC) have reported major pathological response (MPR) rates ranging from 30.2% to 48.5%. Stereotactic body radiotherapy (SBRT) may have an immunomodulating effect and augment the effect of preoperative immune checkpoint blockade monotherapy. In this single-arm phase 2 trial, we investigated the use of SBRT plus immunochemotherapy in the neoadjuvant setting for patients with resectable NSCLCs.
Methods
Eligiblepatients with resectable NSCLCs (stage II-IIIB as per the 8th edition of the AJCC) without known EGFR/ALK alterations received SBRT (8Gy x 3 fractions) to the primary tumor followed by two cycles of PD-1 inhibitor tislelizumab plus platinum-doublet chemotherapy of each 21-day cycle. Patients without systemic disease progression proceeded to resection 4-6 weeks after treatment. The primary endpoint was MPR defined as 10% or fewer viable tumors in the primary tumor and lymph nodes. The sample size was determined based on Simon’s optimal two-stage design, considering a threshold MPR rate of 30% and an expected MPR rate of 50%. If there were 19 or more MPRs in 46 patients, the null hypothesis can be rejected.
Results
Between May 2022, and June 2023, 46 patients were enrolled, with 38 (82.6%) having stage III diseases. Two surgeries were canceled due to disease progression and G5 neutropenia, respectively. Forty-four (95.7%) patients underwent R0 resection and none of them required pneumonectomy. The study met the primary endpoint. The MPR rate was 76.1% (35/46, 95% CI: 61.2-87.4), and pathological complete response rate was 52.2% (24/46, 95% CI: 36.9-67.1). Nodal clearance (ypN0) was found in 35 of 46 cN1/2 cases (76.1%). Grade 3 or greater adverse events related to neoadjuvant treatment occurred in 12 patients (26.1%), the most frequent being neutropenia (13.0% [n=6]), pneumonia (4.3% [n=2]), and anemia (4.3% [n=2]). Two patients had delayed operations due to G3 pneumonia (77 and 134 days after the last cycle of immunochemotherapy). No deaths within 30 days of surgery were reported.
Conclusions
Neoadjuvant SBRT followed by immunochemotherapy is well tolerated, feasible, and yielded a high MPR rate.
Clinical trial identification
NCT05319574 Release date: April 8, 2022.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
1291O - Radiotherapy boost to 74 Gy based on FDG-PET at 42 Gy of radiochemotherapy (RCT) in patients with inoperable stage III non-small cell lung cancer (RTEP7 – IFCT 1401): A prospective multicentre, open-label, randomised, controlled trial
- Gerard Zalcman (Paris, France)
Abstract
Background
To assess the possibility and safety of a boost delivery up to74 Gy, based on lung tumour early response to on-treatment FDG-PET /CT (42 Gy), in inoperable patients with stage III non-small-cell lung cancer (NSCLC)treated with concomitant radio-chemotherapy (RCT).
Methods
158 patients were prospectively included in a multicentre phase II-III study. Patients were randomized into two groups: patients from arm A (experimental) with residual metabolism on FDG-PET2 at 42 Gy received a radiation boost (74 Gy), while patients without residual uptake on FDG-PET2 at 42 Gy and patients in arm B (standard) received a standard radiotherapy (RT) dose (66 Gy). Local control rate (LCR%), median overall survival (OS, months), and progression-free survival (PFS) were analysed for three years after the end of RCT. FDG-PET parameters were measured at baseline (PET1), 42 Gy (PET2), and 6 months post-RCT (PET3). All patients were evaluated with the RECIST 1.1 criteria. The main objective was the LCR at 1 year after RCT.
Results
Patient demographic characteristics and FDG-PET parameters were similar between the two arms (A vs. B). The mean age was 62.3 years; 53.2% of lesions were stage IIIA and 45.6% were stage IIIB. The mean radiation dose was 71.65 Gy for experimental arm and 66 Gy for standard arm (p < 0.001). The median follow-up time was 45.1 months. The LCR at 1 year after RCT was 77.6% [95% CI: 67.6% – 87.6%] in arm A and 71.2% [95% CI : 60.8% - 81.6%] in arm B. The median OS and the PFS (months) were respectively NR [95% CI: 40.9 – NR] in arm A and 43.3 [95% CI: 33.4 - NR] in arm B, and 22.3 [95% CI: 14.8 – 33.7] in arm A and 12.3 [95% CI : 9.4 – 23.3] in arm B. Using multivariate analysis, ΔSUVmax > 66% (p < 0.01), Δ metabolic tumoral volume (MTV) > 100% (p = 0.04) between PET1 and PET3, and the boost realization (p = 0.05) were the only predictors of PFS. There were less acute or late toxicity in boost radiation arm.
Conclusions
Boost at 74 Gy based on interim FDG-PET is feasible and safe during thoracic RCT, without acute or late toxicity. Boost administration, ΔSUVmax, ΔMTV seem to be prognostic factors in patients with stage III inoperable NSCLC.
Clinical trial identification
N° ID RCB°: 2014-A01628-39.
Legal entity responsible for the study
Centre Henri Becquerel.
Funding
French Ministry of health (PHRC K-2014); IFCT.
Disclosure
P. Boisselier: Financial Interests, Personal, Other, Support for attending meetings and/or travel: Merck, Serono, MSD, AstraZeneca. C. Le Pechoux: Financial Interests, Institutional, Speaker, Consultant, Advisor: MSD; Financial Interests, Personal, Other, Support for attending meetings and/or travel: Janssen, Roche, Ose; Financial Interests, Institutional, Advisory Board: AstraZeneca, BMS, Roche, Varian. E. Giroux-Leprieur: Financial Interests, Personal, Speaker, Consultant, Advisor: Amgen, AstraZeneca, Ipsen, Janssen, Lilly, MSD, Novartis, Pfizer, Sanofi, Takeda; Financial Interests, Personal, Other, Support for attending meetings and/or travel: Takeda, MSD, AstraZeneca, Roche. C. Audigier Valette: Financial Interests, Personal, Advisory Board: Roche, BMS, MSD, AstraZeneca, Sanofi, Janssen; Financial Interests, Personal, Invited Speaker: Pfizer. S. Thureau: Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Other, Expertise: AstraZeneca. G. Zalcman: Financial Interests, Institutional, Other, Honorarium: BMS, AstraZeneca, Roche, Pfizer. All other authors have declared no conflicts of interest.
Invited Discussant LBA60 and 1291O
- Rafal Dziadziuszko (Gdansk, Poland)
Q&A
- All Speakers (Lugano, Switzerland)
LBA98 - Efficacy and safety of ramucirumab plus carboplatin and paclitaxel in untreated metastatic thymic carcinoma: RELEVENT phase II trial
- Claudia Proto (Milan, Italy)
Abstract
Background
Thymic carcinoma (TC) is a rare tumor with aggressive and poorly responsive behavior. In advanced lines, antiangiogenics showed activity in TC. Ramucirumab (R) is a VEGF2 inhibitor monoclonal antibody already approved for other solid tumors. RELEVENT trial was design to assess activity and safety of the combination of R plus carboplatin (CBDCA) and paclitaxel (PTX) as first line treatment in patients (pts) with advanced TC.
Methods
This academic open-label single arm phase II trial was conducted within the Italian network TYME. Eligible pts had naive advanced TC (pathological diagnosis was centrally reviewed). All pts received R 10 mg/kg, CBDCA AUC5 and PTX 200 mg/m2 d1q21 for 6 cycles, followed by R 10 mg/kg maintenance until disease progression or intolerable toxicity. The trial was conceived with a Green-Dahlberg 2-stage design, 30 pts were analyzed in the 1st stage (null hypothesis ORR 20%). In case of at least 5 responses, further 25 pts could have been added in the 2nd stage. The primary endpoint was ORR. DCR, PFS, OS and safety were secondary endpoints. A centralized radiologic review was performed.
Results
From 11/2018 to 06/2023, 52 pts were screened and 37 were enrolled. Median (m) age was 60.5 years, 26 (70.3%) pts were male and 32 (86.5%) had stage IVB disease. ECOG PS was 0 in 26 (70%) and 1 in 11 (30%) pts; 35 pts were assessable for the primary endpoint ORR. At the 1st stage, ORR (by investigator assessment) was 80% [95%CI 63.1-91.6] with DCR of 100% [95%CI 90-100]. At the centralized radiological review on 33/35 evaluable pts, ORR was 57.6% [95%CI 39.2-74.5], with 19 pts (57.6%) having a PR and 14 (42.4%) a SD, DCR was 100% [95%CI 89-100]. After a m follow up of 31.6 months [21.6-40.5], mPFS was 18.1 [95%CI 10.5-52.3] and mOS 43.8 [95%CI 22.5-NE] months. Of 35 pts, 28 (80%) experienced at least one treatment related adverse event (AE), 45.7% were G3 or more, (hypertension 8.8% and neutropenia 20% were the most common).
Conclusions
In previously untreated advanced TC, the addition of R to CBDCA and PTX showed highest activity compared to historical controls, with manageable safety profile. Despite the small number of pts, given the rarity of the disease, these results support the use of this combination as first line treatment in TC.
Clinical trial identification
NCT03921671.
Legal entity responsible for the study
Fondazione IRCCS Istituto Nazionale dei Tumori.
Funding
AIFA - Lilly.
Disclosure
C. Proto: Financial Interests, Personal and Institutional, Other: BMS and MSD. F.G.M. De Braud: Financial Interests, Personal and Institutional, Other: Amgen, AstraZeneca, Boehringer-Ingelheim, BMS, Eli Lilly, F. Hoffmann-La Roche, Ignyta, Merck Sharp and Dohme, Merck Serono, Novartis, Pfizer.. R. Berardi: Financial Interests, Advisory Role: AZ, BOERINGHER, MSD, LILLY, Roche, Amgen, GSK, EISAI, BMS. P.A. Zucali: Financial Interests, Advisory Role: Merck Sharp & Dohme (MSD), Astellas, Janssen, Sanofi, Ipsen, Pfizer, Novartis, Bristol Meyer Squibb, Amgen, AstraZeneca, Roche, and Bayer. M.C. Garassino: Financial Interests, Advisory Role: AstraZeneca, MSD International GmbH, BMS, Boehringer Ingelheim Italia S.p.A, Celgene, Eli Lilly, Ignyta, Incyte, Inivata, MedImmune, Novartis, Pfizer, Roche, Takeda. G. Lo Russo: Financial Interests, Invited Speaker: Eli Lilly, BMS, Italfarmaco, Novartis, AstraZeneca, Merck Sharp and Dohme, Takeda, Amgen, F. Hoffmann-La Roche, Sanofi, Pfizer, GSK. All other authors have declared no conflicts of interest.
LBA92 - Tarlatamab for patients (pts) with previously treated small cell lung cancer (SCLC): Primary analysis of the phase II DeLLphi-301 study
- Luis Paz-Ares (Madrid, Spain)
Abstract
Background
Tarlatamab, a bispecific T-cell engager (BiTE), represents a new immunotherapeutic approach for SCLC. It binds to both delta-like ligand 3 (DLL3) on SCLC cells and CD3 on T cells, resulting in T-cell mediated tumor lysis. A phase 1 study demonstrated encouraging safety and efficacy (median duration of response (mDoR): 12.3 mo; median overall survival (mOS): 13.2 mo) in previously treated SCLC. Here, the phase 2 data from the DeLLphi-301 study are presented.
Methods
Pts with SCLC who relapsed after 1 platinum-based regimen (± checkpoint inhibitor) and at least 1 other prior line of therapy received 10 mg or 100 mg tarlatamab Q2W. The primary endpoint was objective response rate (ORR) by blinded independent central review (RECIST 1.1). Other endpoints were DoR, progression-free survival (PFS), OS, and treatment-emergent adverse events (TEAEs).
Results
Overall, 220 pts received tarlatamab. The median follow-up was 10.6 mo for efficacy outcomes (Table). At the 10 mg dose, ORR was 40.0%, mPFS was 4.9 mo, mOS was 14.3 mo, and mDoR was not reached, with 57.5% of responders experiencing ≥ 6 mo of response and 55.0% still with an ongoing response. The most common TEAE was cytokine release syndrome (CRS; 51.1%, 10 mg; 60.9%, 100 mg), primarily occurring in cycle 1, and was mostly grade 1 or 2. Incidence of grade 3 CRS (0.8%, 10 mg; 5.7%, 100 mg) and grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS) and associated neurologic events was low (0%, 10 mg; 4.6%, 100 mg), with no grade 4 or 5 events. Discontinuations due to treatment-related AEs were infrequent (3.0%, 10 mg; 3.4%, 100 mg). Similar safety profiles were seen with 24h or 48h inpatient monitoring. *Efficacy analysis set per intention-to-treat (ITT) analysis (Pts in safety substudy (n = 34) not included as data immature). NE = not estimable
10 mg (n = 100)* 100 mg (n = 88)* ORR, % (97.5% CI) 40.0 (29.1–51.7) 31.8 (21.1–44.1) Complete response, n (%) 1 (1.0) 7 (8.0) Partial response, n (%) 39 (39.0) 21 (23.9) Stable disease, n (%) 30 (30.0) 27 (30.7) Progressive disease, n (%) 20 (20.0) 13 (14.8) Not evaluable, n (%) 2 (2.0) 4 (4.5) Death before post-baseline scan, n (%) 6 (6.0) 13 (14.8) No post-baseline scan, n (%) 2 (2.0) 3 (3.4) mDoR, mo (95% CI) NE (5.9–NE) NE (6.6–NE) Disease control rate % (95% CI) 70.0 (60.0, 78.8) 62.5 (51.5, 72.6) mOS, mo (95% CI) 14.3 (10.8–NE) NE (12.4–NE) mPFS, mo (95% CI) 4.9 (2.9–6.7) 3.9 (2.6–4.4)
Conclusions
Tarlatamab demonstrated impressive antitumor activity with durable responses and promising survival. Tarlatamab showed a favorable benefit-risk profile with no new safety signals, supporting the use of tarlatamab in pts with previously treated SCLC.
Clinical trial identification
NCT05060016.
Editorial acknowledgement
Medical writing support for the development of this abstract was provided by Liz Leight, PhD, an employee of Amgen Inc. and Sukanya Raghuraman, PhD, of Cactus Life Sciences, part of Cactus Communications, and was funded by Amgen Inc.
Legal entity responsible for the study
Amgen Inc.
Funding
Amgen Inc.
Disclosure
L. Paz-Ares: Financial Interests, Personal, Invited Speaker: MSD, Lilly, Janssen Pharmaceuticals, Mirati Therapeutics, Bristol Myers Squibb, AstraZeneca, PharmaMar, GSK, Sanofi; Financial Interests, Personal, Member of Board of Directors: STAb Therapeutics, Altum sequencing; Non-Financial Interests, Personal, Member: IASLC, ESMO, SEOM, ASEICA, CNIO, ONCOSUR, AECC, CRIS; Financial Interests, Personal, Advisory Role: Lilly, MSD, Roche, PharmaMar, Merck, AstraZeneca, Novartis, Servier, Amgen, Pfizer, Sanofi, Bayer, Bristol Myers Squibb, Mirati Therapeutics, GSK, Janssen, Takeda, Daiichi Sankyo. M. Ahn: Financial Interests, Personal, Invited Speaker: AstraZeneca, Yuhan, Takeda, Amgen, MSD, Merck, Daiichi Sankyo; Financial Interests, Personal, Other, Consultancy (including expert testimony): AstraZeneca, Yuhan, Arcus, Takeda, Amgen, MSD, Merck, Daiichi Sankyo, Alpha Pharmaceuticals, Pfizer, Voronoi, Eutilex; Financial Interests, Personal, Advisory Role: AstraZeneca, Yuhan, Arcus, Takeda, Amgen, MSD, Merck, Daiichi Sankyo, Alpha Pharmaceuticals, Pfizer, Voronoi, Eutilex. E. Felip: Financial Interests, Personal, Advisory Board: AbbVie, Amgen, AstraZeneca, Bayer, BeiGene, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, F. Hoffmann-La Roche, Gilead, GSK, Janssen, Merck Serono, Merck Sharp & Dohme, Novartis, Peptomyc, Regeneron, Sanofi, Takeda, Turning Point, Pfizer; Financial Interests, Personal, Invited Speaker: Amgen, Daiichi Sankyo, Genentech, Janssen, Medical Trends, Medscape, Merck Serono, PeerVoice, Pfizer, Sanofi, Takeda, Touch Oncology, AstraZeneca, Bristol Myers Squibb, Eli Lilly, F. Hoffmann-La Roche, Merck Sharp & Dohme; Financial Interests, Personal, Member of Board of Directors, Independent member: Grifols; Financial Interests, Institutional, Local PI, Clinical Trial: AstraZeneca AB, AbbVie, Amgen, Bayer Consumer Care AG, BeiGene, Boehringer Ingelheim GmbH, Bristol-Myers Squibb International Corporation, Daiichi Sankyo Inc., Exelixis Inc., F. Hoffmann-La Roche Ltd., Genentech Inc., GSK Research and Development Limited, Janssen Cilag International NV, Merck Sharp & Dohme Corp, Merck KGAA, Mirati Therapeutics Inc, Novartis Pharmaceutica SA, Pfizer, Takeda Pharmaceuticals International; Non-Financial Interests, Leadership Role, President (2021-2023): SEOM (Sociedad Espanola de Oncologia Medica); Non-Financial Interests, Member, Member of Scientific Committee: ETOP (European Thoracic Oncology Platform); Non-Financial Interests, Member, Member of the Scientific Advisory Committee: CAC Hospital Universitari Parc Taulí. S. Handzhiev: Financial Interests, Institutional, Advisory Board: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim; Non-Financial Interests, Institutional, Principal Investigator: Boehringer Ingelheim, Amgen. I. Korantzis: Financial Interests, Personal, Principal Investigator: Amgen Inc.; Financial Interests, Personal, Sponsor/Funding: Amgen Inc.. H. Izumi: Financial Interests, Personal, Invited Speaker: Takeda, Merck, Ono Pharmaceutical, MSD, Chugai, Bristol Myers Squibb, Japan; Financial Interests, Institutional, Principal Investigator: AbbVie, AstraZeneca, Amgen, Takeda, Eisai, Ono Pharmaceutical; Financial Interests, Personal, Advisory Role: Amgen. K. Ohashi: Financial Interests, Personal, Invited Speaker: Eli Lilly Japan, Kyowa-Kirin, Chugai Pharmaceutical Co., Ltd., Novartis Japan; Financial Interests, Institutional, Local PI: BeiGene, Daiichi-Sakyo, Amgen, Eli Lilly; Financial Interests, Personal, Research Grant: Daiichi Sankyo, Eli Lilly Japan, Chugai Pharmaceutical Co., Ltd.. M. Majem: Financial Interests, Personal, Advisory Board: Amgen, Roche, AstraZeneca, Takeda, Janssen, Cassen Recordati, BMS; Financial Interests, Personal, Invited Speaker: Amgen, Roche, AstraZeneca, Pfizer, Takeda, Helsinn; Financial Interests, Institutional, Funding: BMS, AstraZeneca, Roche. J. Wolf: Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, Blueprint, BMS, Boehringer-Ingelheim, Daiichi Sankyo, Ignyta, Janssen, Lilly, Loxo, MSD, Novartis, Pfizer, Roche, Seattle Genetics, Takeda; Financial Interests, Personal, Invited Speaker: Bayer, Chugai; Financial Interests, Institutional, Research Grant: BMS, Janssen, Novartis, Pfizer. M. Reck: Financial Interests, Personal, Invited Speaker: Amgen, AstraZeneca, BMS, Boehringer-Ingelheim, Lilly, MSD, Merck, Novartis, Regeneron, Roche, Sanofi; Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, BMS, Biontech, Boehringer-Ingelheim, Daiichi Sankyo, Gilead, MSD, Mirati, Pfizer, Regeneron, Sanofi, Roche; Financial Interests, Personal, Other, Member of DMSB: Daiichi Sankyo. H. Hummel: Non-Financial Interests, Institutional, Principal Investigator: Amgen Inc., Revolution Medicines, Boehringer Ingelheim, Bristol Myers Squibb, Merck, Novartis, AstraZeneca, Dracen Pharmaceutical, Daiichi Sankyo, AvenCell, Celgene; Financial Interests, Institutional, Sponsor/Funding: Amgen Inc., Boehringer Ingelheim, Bristol Myers Squibb, Johnson & Johnson, Revolution Medicines, AstraZeneca, Daiichi Sankyo; Financial Interests, Personal, Advisory Role: Amgen Inc., Boehringer Ingelheim, Bristol Myers Squibb, Johnson & Johnson; Financial Interests, Personal, Steering Committee Member: Amgen Inc.. F. Blackhall: Financial Interests, Personal, Invited Speaker, Educational Symposium lecture: AstraZeneca; Financial Interests, Personal, Advisory Board, NTRK Advisory Board and guidelines for diagnosis: Bayer; Financial Interests, Personal, Other, IDMC Chair: AstraZeneca; Financial Interests, Personal, Advisory Board, Small cell Advisory Board Oct 2020: Amgen; Financial Interests, Personal, Invited Speaker, ESMO Satellite Symposium November 2020: Takeda; Financial Interests, Personal, Other, Consultancy for RETinhibitor development: Blueprint; Financial Interests, Personal, Other, Real world evidence research study design and analysis (EGFR): Janssen; Financial Interests, Institutional, Coordinating PI, Institutional payment for clinical trial activities: Amgen, Pfizer; Financial Interests, Institutional, Coordinating PI, Payment for clinical trial activities: Mirati; Financial Interests, Institutional, Coordinating PI, Clinical trial activities: BMS; Financial Interests, Institutional, Funding, Real world evidence research programme: Roche; Non-Financial Interests, Advisory Role, Application of genotyping platforms in lung cancer: Guardant Health; Non-Financial Interests, Advisory Role, Clinical trials of IMPs in lung cancer and translational lung cancer biomarkers: Astra-Zeneca. A.C. Dingemans: Financial Interests, Institutional, Advisory Board: Roche, Sanofi, Amgen, Bayer, Boehringer Ingelheim; Financial Interests, Institutional, Invited Speaker: Takeda, Lilly, Jansen, Pfizer, AstraZeneca; Financial Interests, Institutional, Research Grant: Amgen; Financial Interests, Institutional, Local PI: Lilly, Amgen, Daiichi, JNJ, Mirati; Financial Interests, Institutional, Coordinating PI: Roche; Financial Interests, Institutional, Steering Committee Member: Roche; Non-Financial Interests, Other, Chair EORTC lung cancer group: EORTC; Non-Financial Interests, Member: IASCL, ASCO, AACR. T.K. Owonikoko: Financial Interests, Institutional, Research Funding: Novartis, Bayer, Regeneron, AstraZeneca, G1 Therapeutics, Bristol-Myers, United Therapeutics, Amgen, Loxo/Lilly, Fujifilm, Pfizer, Aeglea Biotherapeutics, Incyte, Merck, Mersana, Turning Point, Oncorus, Ipsen, Eisai, Roche/Genentech, Cardiff Oncology, Ymabs; Financial Interests, Personal, Advisory Board, Consulting/Advisory Board: Novartis, Lilly, AbbVie, Eisai, G1 Therapeutics, Bristol Myers Squibb, Amgen, AstraZeneca, PharmaMar, Boehringer Ingelheim, EMD Serono, XCovery, Bayer, Merck, Oncocyte, Takeda, Jazz, Zentalis, Ipsen, Daiichi Sankyo, Janssen, BeiGene, Genentech, Exelixis, Coherus, GenCART, Heat Biologics, Meryx; Financial Interests, Personal, Other, Independent Review Committees/Data and Safety Monitoring Board: EMD Serono, Roche/Genentech, Takeda; Financial Interests, Personal, Stocks or ownership: Cambium Oncology, Taobob LLC, Coherus Biosciences, GenCART. S.S. Ramalingam: Financial Interests, Personal, Other, Editor in Chief, CANCER journal: American Cancer Society; Financial Interests, Research Grant: Merck, AstraZeneca, Advaxis, BMS, Amgen, Takeda, Genmab, GSK. J. Sands: Financial Interests, Personal, Speaker, Consultant, Advisor: Arcus, Amgen Inc., AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, PharmaMar, Guardant Health, Sanofi, Takeda; Non-Financial Interests, Personal and Institutional, Principal Investigator: Amgen Inc., Lilly, Merck, Genentech, Daiichi Sankyo, PharmaMar, Phanes Therapeutics, Inc, Legend Biotech; Financial Interests, Personal, Advisory Role: Curadev Pharma. T. Jiang, S. Mukherjee, E. Anderson: Financial Interests, Personal, Full or part-time Employment: Amgen Inc.; Financial Interests, Personal, Stocks/Shares: Amgen Inc.. B.C. Cho: Financial Interests, Personal, Other, Consulting role: Abion, BeiGene, Novartis, AstraZeneca, Boehringer-Ingelheim, Roche, BMS, CJ, CureLogen, Cyrus therapeutics, Ono, Onegene Biotechnology, Yuhan, Pfizer, Eli Lilly, GI-Cell, Guardant, HK Inno-N, Imnewrun Biosciences Inc., Janssen, Takeda, MSD, Janssen; Financial Interests, Personal, Advisory Board: KANAPH Therapeutic Inc, Bridgebio therapeutics, Cyrus therapeutics, Guardant Health, Oscotec Inc; Financial Interests, Personal, Other, Advisory role: Medpacto, Blueprint medicines, RandBio, Hanmi; Financial Interests, Personal, Member of Board of Directors: Interpark Bio Convergence Corp., J INTS BIO; Financial Interests, Personal, Stocks/Shares: TheraCanVac Inc, Gencurix Inc, Bridgebio therapeutics, KANAPH Therapeutic Inc, Cyrus therapeutics, Interpark Bio Convergence Corp., J INTS BIO; Financial Interests, Personal, Royalties: Champions Oncology, Crown Bioscience, Imagen; Financial Interests, Institutional, Research Grant: MOGAM Institute, LG Chem, Oscotec, Interpark Bio Convergence Corp, GIInnovation, GI-Cell, Abion, AbbVie, AstraZeneca, Bayer, Blueprint Medicines, Boehringer Ingelheim, Champions Onoclogy, CJ bioscience, CJ Blossom Park, Cyrus, Dizal Pharma, Genexine., Janssen, Lilly, MSD, Novartis, Nuvalent, Oncternal, Ono, Regeneron, Dong-A ST, Bridgebio therapeutics, Yuhan, ImmuneOncia, Illumina, Kanaph therapeutics, Therapex, JINTSbio, Hanmi, CHA Bundang Medical Center; Other, Founder: DAAN Biotherapeutics.
Invited Discussant LBA98 and LBA92
- Pilar Garrido Lopez (Madrid, Spain)
Q&A
- All Speakers (Lugano, Switzerland)