All times are listed in CEST (Central European Summer Time)
- Solange Peters (Lausanne, Switzerland)
- Jean-Yves Blay (Lyon, France)
LBA1 - CheckMate 77T: Phase III study comparing neoadjuvant nivolumab (NIVO) plus chemotherapy (chemo) vs neoadjuvant placebo plus chemo followed by surgery and adjuvant NIVO or placebo for previously untreated, resectable stage II–IIIb NSCLC
- Tina Cascone (Houston, United States of America)
Abstract
Background
Neoadjuvant (neoadj) NIVO + chemo provides efficacy benefit vs chemo in patients (pts) with resectable NSCLC. However, the efficacy of perioperative NIVO + chemo has not been evaluated in phase 3 studies. Here, we report prespecified interim analysis results from CheckMate 77T, a randomized, double-blind, phase 3 study evaluating neoadj NIVO + chemo followed by surgery and adjuvant (adj) NIVO (NIVO + chemo/NIVO) compared with neoadj placebo + chemo followed by surgery and adj placebo (chemo/PBO) in resectable stage II–IIIB NSCLC.
Methods
Adults with untreated resectable stage IIA (>4 cm)–IIIB (N2) NSCLC (AJCC v8),
Results
Baseline characteristics were balanced between arms (NIVO + chemo/NIVO, n = 229; chemo/PBO, n = 232). At a minimum follow-up of 15.7 mo, NIVO + chemo/NIVO significantly improved EFS vs chemo/PBO (median [95% CI], not reached [28.9 mo–not reached] vs 18.4 mo [13.6–28.1]; HR [97.36% CI], 0.58 [0.42–0.81];
Conclusions
CheckMate 77T met its primary endpoint with a statistically significant and clinically meaningful improvement in EFS with neoadj NIVO + chemo followed by surgery and adj NIVO vs chemo/PBO in pts with resectable NSCLC. No new safety signals were noted with the NIVO + chemo/NIVO regimen.
Clinical trial identification
NCT04025879.
Editorial acknowledgement
Editorial assistance was provided by Adel Chowdhury, PharmD and Samantha Dwyer, PhD of Ashfield MedComms, an Inizio company.
Legal entity responsible for the study
Bristol Myers Squibb.
Funding
Bristol Myers Squibb.
Disclosure
T. Cascone: Financial Interests, Institutional, Speaker, Consultant, Advisor: Society for Immunotherapy of Cancer (SITC), MarkFoundation for Cancer Research, Bristol Myers Squibb, Roche, Medscape, IDEOlogy Health, Physicians' Education Resource® LLC (PER®), OncLive and PeerView; Financial Interests, Institutional, Advisory Board: MedImmune/AstraZeneca, Bristol Myers Squibb, Merck, Genentech, Arrowhead Pharmaceuticals, Pfizer Inc. and Regeneron; Financial Interests, Institutional, Other, travel and/or food/beverage: SITC, International Association for the Study of Lung Cancer, Parker Institute for Cancer Immunotherapy, Physicians' Education Resource® LLC (PER®), Dava Oncology, IDEOlogy Health, OncLive, MedImmune/AstraZeneca and Bristol Myers Squibb; Financial Interests, Institutional, Research Funding: EMD Serono, MedImmune/AstraZeneca and Bristol Myers Squibb. M.M. Awad: Financial Interests, Personal, Other, consultant: 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. J.D. Spicer: Financial Interests, Institutional, Research Grant: AstraZeneca, BMS, CLS Therapeutics, Protalix Biotherapeutics, Merck, Roche; Financial Interests, Personal, Other, consulting fees: Roche, Merck, BMS, AstraZeneca, Regeneron, Protalix Biotherapeutics, Xenetic Biosciences, Amgen, Novartis; Financial Interests, Personal, Speaker’s Bureau: PeerView, BMS, AstraZeneca Payments to me; Non-Financial Interests, Personal, Advisory Board: PUCC trial; Non-Financial Interests, Personal, Leadership Role: Industry chair for Canadian Association of Thoracic Surgeons. S. Lu: Financial Interests, Institutional, Invited Speaker: Hansoh, AstraZeneca, Roche, Hengrui; Financial Interests, Institutional, Advisory Board: AdtraZeneca, Prizer, Boehringerlngelheim, 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. B. Sepesi: Financial Interests, Personal, Speaker, Consultant, Advisor, Consulting and speaking fees: AstraZeneca, Medscape; Financial Interests, Personal, Speaker, Consultant, Advisor, Speaking fees: PEER VIEW. F. Tanaka: Financial Interests, Personal and Institutional, Research Grant: Boehringer Ingelheim Japan, Ono Pharmaceutical, Taiho Pharmaceutical, Eli Lilly Japan, Chugai Pharmaceutical; Financial Interests, Personal, Speaker, Consultant, Advisor: AstraZeneca, Chugai Pharmaceutical, Ono Pharmaceutical; Financial Interests, Personal, Speaker’s Bureau: MSD, BMS, Boehringer Ingelheim Japan, Ono Pharmaceutical, Johnson and Johnson, Covidien Japan, Taiho Pharmaceutical, Eli Lilly Japan, AstraZeneca, Chugai Pharmaceutical, Kyowa-Kirin, Takeda Pharmaceutical, Pfizer, Olympus, Stryker, Intuitive Japan. J.M. Taube: Financial Interests, Personal, Speaker, Consultant, Advisor, Consulting fees: Bristol Myers Squibb, Merck & Co, AstraZeneca, Roche Pharmceuticals; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Other, Patent: Machine learning algorithm for irPRC. R. Cornelissen: Financial Interests, Personal, Other, consulting fees: Janssen, MSD, Spectrum; Financial Interests, Personal, Speaker’s Bureau: Librerium; Financial Interests, Personal, Other, Support for attending meetings and travel: Librerium. J. Kuzdzal: Financial Interests, Institutional, Research Funding: BMS, Roche; Financial Interests, Institutional, Research Grant: Jagiellonian University Medical College; Financial Interests, Personal, Other, Support for attending meetings and/or travel: Jagiellonian University Medical College, John Paul II Hospital,; Financial Interests, Personal, Stocks/Shares: Medycyna Praktyczna Publishing House, Medycyna Praktyczna Education, and Technet. L. Wu: Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, BMS, Hengrui Medicine, Innovate Biopharmaceuticals, Lilly, MSD, Pfizer, Roche. C. Coronado Erdmann: Financial Interests, Personal, Full or part-time Employment: BMS; Financial Interests, Personal, Stocks or ownership: BMS, Incyte. S. Meadows-Shropshire: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks or ownership: 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.
LBA2 - ALINA: Efficacy and safety of adjuvant alectinib versus chemotherapy in patients with early-stage ALK+ non-small cell lung cancer (NSCLC)
- Ben J. Solomon (Melbourne, Australia)
Abstract
Background
For patients (pts) with resected, stage IB–IIIA,
Methods
Eligible pts were ≥18 years old, had an ECOG PS of 0/1 and completely resected, stage IB (≥4 cm)–IIIA,
Results
A total of 257 pts were randomised to receive alectinib (n=130) or CT (n=127); baseline characteristics were overall well balanced between arms. At data cutoff (26 June 2023), median follow up was 27.8 months. A significant DFS benefit was observed with alectinib vs CT in both the stage II–IIIA (HR 0.24; 95% CI: 0.13–0.45) and ITT populations (HR 0.24; 95% CI: 0.13–0.43; Table). A clinically meaningful CNS-DFS benefit was observed in the ITT population (HR 0.22; 95% CI 0.08–0.58). OS data were immature. No unexpected safety findings were observed.
Conclusions
Alectinib is the first ALK inhibitor to significantly improve DFS compared with CT and provides an effective new treatment strategy for pts with resected AEs, adverse events; NE, not estimable. ∗No Grade 5 AEs in either treatment arm
Stage II–IIIA ITT (Stage IB–IIIA) Efficacy Alectinib (n=130) DFS events, n (%) 14 (12.1) 45 (39.1) 15 (11.5) 50 (39.4) Median DFS, months (95% CI) NE 44.4 (27.8–NE) NE 41.3 (28.5–NE) Stratified HR (95% CI) 0.24 (0.13–0.45) 0.24 (0.13–0.43) <0.0001 <0.0001 24-month DFS rate, % 93.8 63.0 93.6 63.7 36-month DFS rate, % 88.3 53.3 88.7 54.0 Safety Alectinib Grade 3–4 AEs, n (%)* 38 (29.7) 37 (30.8) Serious AEs, n (%) 17 (13.3) 10 (8.3) Serious treatment-related AEs, n (%) 2 (1.6) 8 (6.7) AEs leading to treatment withdrawal, n (%) 7 (5.5) 15 (12.5)
Clinical trial identification
NCT03456076.
Editorial acknowledgement
Third-party medical writing assistance was provided by Sean R Mills, PhD of Ashfield MedComms, an Inizio company, and was funded by F. Hoffmann-La Roche Ltd.
Legal entity responsible for the study
F. Hoffmann-La Roche Ltd.
Funding
F. Hoffmann-La Roche Ltd.
Disclosure
B.J. Solomon: Financial Interests, Personal, Invited Speaker: Roche/Genentech, Pfizer, AstraZeneca, Amgen, GSK; Financial Interests, Personal, Advisory Board: Roche/Genentech, Pfizer, Merck, Bristol Myers Squibb, AstraZeneca, Amgen, Lilly, Beigene, D3 Bio, Takeda, Janssen, GSK; Non-Financial Interests, Personal, Member of Board of Directors: Cancer Council of Victoria, Thoracic Oncology Group of Australasia, International Association for the Study of Lung Cancer; Financial Interests, Institutional, Research Grant: Sanofi ; Financial Interests, Institutional, Sponsor/Funding, Clinical trial funding to institution: Pfizer, Novartis, Roche/Genentech, Beigene, Lilly, Bristol Myers Squibb, Nuvalent, AstraZeneca. J.S. Ahn: Financial Interests, Personal, Invited Speaker: Takeda Pharm, Novartis Korea, Yuhan, Samyang, Amgen Korea, Boryung, BC World, Roche Korea, Menarini Korea, Pfizer, Lilly Korea, Boehringer Ingelheim, Kyowa Kirin, AstraZeneca Korea, Bayer Korea, Hanmi; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Role: Immuneoncia, Daiichi Sankyo Korea, Pharmbio Korea, Therapex, Guardant, Bayer Korea, Yooyoung, Vifor Pharma, Bixink. R. Dziadziuszko: Financial Interests, Personal, Invited Speaker: Roche, Pfizer, Amgen; Financial Interests, Personal, Advisory Board: Roche, AstraZeneca, Takeda, Novartis, MSD, Bristol Myers Squibb, Pfizer. F. Barlesi: Financial Interests, Institutional, Advisory Board: AstraZeneca, Bayer, Bristol Myers Squibb, Boehringer Ingelheim, Eli Lilly Oncology, F. Hoffmann–La Roche Ltd, Novartis, Merck, Mirati, MSD, Pierre Fabre, Pfizer, Sanofi Aventis, Seattle Genetics, Takeda, AbbVie, ACEA, Amgen, Eisai, Ignyta; Non-Financial Interests, Principal Investigator: AstraZeneca, BMS, Merck, Pierre Fabre, F. Hoffmann-La Roche Ltd., Innate Pharma, Mirati. M. Nishio: Financial Interests, Personal, Speaker’s Bureau: Ono Pharmaceuticals, Chugai Pharmaceutical, Taiho Pharmaceutical, Bristol Myers Squibb, Daiichi Sankyo, Lilly, AstraZeneca, MSD, AbbVie, Takeda, Pfizer, Boehringer Ingelheim, Novartis, Nippon Kayaku, Merck, Janssen. D.H. Lee: Financial Interests, Personal, Advisory Role: AbbVie, AstraZeneca, Boehringer-Ingelheim, Bristol-Myers Squibb, Eli Lilly ChongKeunDang, Janssen, MSD, Novartis, Ono, Pfizer, Roche, ST Cube, Takeda, BC World Pharm, Yuhan. H. Horinouchi: Financial Interests, Personal, Invited Speaker: AstraZeneca, Roche/Chugai, Amgen, AbbVie, Daiichi Sankyo, BMS, Ono, MSD; Financial Interests, Institutional, Research Grant: AstraZeneca, AbbVie, Roche/Chugai, Daiichi- Sankyo, MSD, BMS, Ono, Janssen, Bayer, Amgen; Financial Interests, Personal, Advisory Board: AstraZeneca, AbbVie, Daiichi Sankyo, BMS, Ono, Amgen; Financial Interests, Institutional, Principal Investigator: AstraZeneca, AbbVie, Roche/Chugai, MSD, BMS, Ono. M.J. Hochmair: Financial Interests, Personal, Invited Speaker: MSD, Roche, Lilly, AstraZeneca, Takeda; Financial Interests, Personal, Advisory Board: MSD, Roche, Lilly, AstraZeneca, Takeda. F. de Marinis: Financial Interests, Personal, Advisory Board: BMS, AstraZeneca, Novartis, Roche/Genentech, MSD, Merck. M.R. Migliorino: Financial Interests, Personal, Invited Speaker: Roche, Novartis, Takeda, AstraZeneca ; Financial Interests, Personal, Advisory Board: Pfizer. T.O. Lohmann: Financial Interests, Personal, Stocks/Shares: F. Hoffmann-La Roche Ltd; Financial Interests, Personal, Full or part-time Employment: F. Hoffmann-La Roche Ltd. T. Xu: Financial Interests, Personal, Full or part-time Employment: F. Hoffmann-La Roche Ltd. A. Cardona Gavaldon: Financial Interests, Institutional, Stocks/Shares: F. Hoffmann-La Roche Ltd; Financial Interests, Institutional, Full or part-time Employment: F. Hoffmann-La Roche Ltd. W. Bordogna: Financial Interests, Personal, Full or part-time Employment: F. Hoffmann-La Roche; Financial Interests, Personal, Stocks/Shares: F. Hoffmann-La Roche. T. Ruf: Financial Interests, Personal, Stocks/Shares: F. Hoffmann-La Roche Ltd ; Financial Interests, Personal, Full or part-time Employment: F. Hoffmann-La Roche Ltd. Y. Wu: Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, Boehringer Ingelheim, Eli Lilly, Hengrui, Merck, MSD, Pfizer, Roche, Sanofi; Financial Interests, Institutional, Research Grant: AstraZeneca, BMS, Boehringer Ingelheim; Non-Financial Interests, Personal, Advisory Board: AstraZeneca, MSD, Takeda; Non-Financial Interests, Personal, Principal Investigator: AstraZeneca, BMS, Boehringer Ingelheim, Eli Lilly, Hengrui, Merck, MSD, Pfizer, Roche. All other authors have declared no conflicts of interest.
Invited Discussant LBA1 and LBA2
- Marina C. Garassino (Chicago, United States of America)
LBA3 - Randomized phase III study of selpercatinib versus cabozantinib or vandetanib in advanced, kinase inhibitor-naïve, RET-mutant medullary thyroid cancer
- Julien Hadoux (Villejuif, Cedex, France)
Abstract
Background
Selpercatinib is a highly selective and potent RET inhibitor approved for treatment of advanced
Methods
LIBRETTO-531 (NCT04211337) is a randomized phase 3 study comparing first-line selpercatinib versus physician’s choice of cabozantinib or vandetanib. Eligible patients had kinase inhibitor-naïve progressive disease documented in the 14 months prior to enrollment. The pre-planned interim efficacy analysis occurred after 59 progression-free survival (PFS) events. The primary endpoint was blinded independent central review (BICR)-assessed PFS.
Results
In total, 291 patients were randomized. Baseline characteristics were well-balanced between study arms. At a median follow-up of 12 months, median PFS by BICR was not reached with selpercatinib remaining inestimable (95% CI: NE, NE) and was 16.8 months (95% CI: 12.2, 25.1) with control (HR: 0.280, 95% CI: 0.165, 0.475; P<.0001); by investigator assessment the HR was 0.187 (95% CI: 0.109, 0.321; P<.0001). BICR overall response rate (ORR) was 69.4% (95% CI: 62.4, 75.8) with selpercatinib compared to 38.8% (95% CI: 29.1, 49.2) with control (odds ratio 3.7, 95% CI, 2.2, 6.3; P<0.0001). At a median follow-up of 15 months, overall survival (OS) was better with selpercatinib (HR: 0.374, 95% CI: 0.147, 0.949). The most common treatment-emergent adverse events observed with selpercatinib were hypertension, dry mouth, and diarrhea; and with control, diarrhea, palmar-plantar erythrodysaesthesia syndrome, and hypertension. In total, 38.9% of patients treated with selpercatinib had a dose reduction (versus 77.3% in control) and 4.7% discontinued treatment due to an adverse event (versus 26.8% in control).
Conclusions
The study met the interim analysis criteria of efficacy. First-line selpercatinib delivered markedly prolonged PFS, improved ORR, and better OS compared with MKI. This study highlights the importance of selectivity in targeting
Clinical trial identification
NCT04211337.
Legal entity responsible for the study
Eli Lilly and Company.
Funding
Eli Lilly and Company.
Disclosure
J. Hadoux: Financial Interests, Personal, Advisory Board: IPSEN, Lilly, Pharma Mar; Financial Interests, Institutional, Invited Speaker: AAA, Pfizer; Financial Interests, Institutional, Advisory Board: EISAI, HRA pharma. R. Elisei: Financial Interests, Personal, Speaker, Consultant, Advisor, consulting fees: Eisai, Ipsen, Eli Lilly and Company, Loxo Oncology, Bayer, Roche; Financial Interests, Personal, Advisory Board: Eisai, Ipsen, Eli Lilly and Company, Loxo Oncology, Bayer, Roche. M.S. Brose: Financial Interests, Institutional, Funding, grant funding: Eli Lilly and Company, Bayer/Loxo Oncology, Exelixis, Blueprint Medicines; Financial Interests, Personal, Speaker, Consultant, Advisor, consulting fees: Bayer, Eli Lilly and Company; Financial Interests, Personal, Advisory Board: Eli Lilly and Company, Bayer, Exelixis, Aadi. A. Hoff: Financial Interests, Personal, Advisory Board: Knight, Bayer; Financial Interests, Personal, Invited Speaker: Bayer; Financial Interests, Personal, Writing Engagement: Bayer; Financial Interests, Personal, Other, Libretto-531 - Steering Committee: Eli Lilly; Financial Interests, Institutional, Local PI, A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer (LIBRETTO-531): Eli Lilly; Financial Interests, Institutional, Coordinating PI, A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Cabozantinib (XL184) in Subjects With Radioiodine-Refractory Differentiated Thyroid Cancer Who Have Progressed After Prior VEGFR-Targeted Therapy.: Exelixis; Financial Interests, Institutional, Local PI, Study of Efficacy and Safety of Dabrafenib Plus Trametinib in Previously Treated Patients With Locally Advanced or Metastatic, Radio-active Iodine Refractory BRAFV600E Mutation-positive Differentiated Thyroid Cancer.: Novartis; Other, Husband - President Oncologia D'OR: Oncologia D'OR. B. Robinson: Financial Interests, Personal, Leadership Role: Cochlear, Mayne Pharma; Financial Interests, Personal, Stocks or ownership: Cochlear, Mayne Pharma; Financial Interests, Personal, Advisory Board: Eisai, Loxo, Blueprint Medicines, Lilly; Financial Interests, Personal, Speaker’s Bureau: Eisai; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Eisai. B. Jarzab: Financial Interests, Personal, Speaker, Consultant, Advisor, Consulting: EwoPharma, IPSEN; Financial Interests, Personal, Advisory Board: Sobi; Financial Interests, Personal, Other, Honoraria: AstraZeneca, Amgen, Bayer Health Care, Eisai, Exelixis, Ipsen, Sanofi-Genzyme, Novartis, Oxigene, Pfizer, Elli Lilly; Financial Interests, Research Funding: AstraZeneca, Bayer Health Care, Eisai, Exelixis, Ipsen, Sanofi-Genzyme, Novartis, Pfizer, Elli Lilly; Financial Interests, Other, clinical trials: AstraZeneca, Bayer Health Care, Eisai, Exelixis, Ipsen, Sanofi-Genzyme, Novartis, Pfizer, Elli Lilly. K. Kopeckova: Financial Interests, Personal, Expert Testimony, Treatment of thyroid cancer: Eli Lilly; Financial Interests, Personal, Advisory Board, Systemic treatment of DTC: Ipsen; Financial Interests, Personal, Invited Speaker, Breast Cancer Treatment with PARP inhibitors: AstraZeneca; Financial Interests, Personal, Other, International collaboration for thyroid cancer: EISAI. J. Wadsley: Financial Interests, Institutional, Invited Speaker, Have regularly spoken at the invitation of Lilly, and attended advisory boards: Lilly; Financial Interests, Institutional, Invited Speaker, Have regularly spoken on behalf of AAA and attended advisory boards: Novartis (AAA); Financial Interests, Institutional, Invited Speaker: Bayer, Roche, AstraZeneca, Incyte; Financial Interests, Institutional, Invited Speaker, Have been invited to speak and to advisory boards: Eisai; Financial Interests, Institutional, Advisory Board: Ipsen; Financial Interests, Personal and Institutional, Invited Speaker, Funding received to run SELIMETRY trial: AstraZeneca; Financial Interests, Personal and Institutional, Invited Speaker, Funding received to support SELIMETRY trial: Sanofi Genzyme; Non-Financial Interests, Principal Investigator, Local PI for LIBRETTO 531 trial: Lilly. D. Führer: Financial Interests, Personal, Advisory Board, honoraria for advisory board: Lilly, Roche, Ipsen, Eisai, Novartis; Financial Interests, Personal, Speaker’s Bureau: Lilly, Roche, Ipsen, Eisai, Novartis. B. Keam: Financial Interests, Personal, Invited Speaker: Merck, Lily, MSD Oncology, AstraZeneca, Ono Pharmaceutical; Financial Interests, Personal, Advisory Board: Handok, TrialInformatics, ImmunOncia, NeoImmunetech, Beigen. E.J. Sherman: Financial Interests, Personal, Advisory Board: Eisai, Roche, Regeneron, Exelixis, Bayer; Financial Interests, Invited Speaker: Novartis; Financial Interests, Institutional, Invited Speaker: Regeneron; Financial Interests, Institutional, Invited Speaker, Also Local PI: Eli Lilly; Non-Financial Interests, Principal Investigator, PI of randomized study in thyroid cancer: Novartis. M. Tahara: Financial Interests, Personal, Advisory Board: Merck Biopharma, Ono pharma, Bristol- Myers Squibb, MSD, Pfizer, Bayer, Lilly, Rakuten Medical, Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: Eisai; Financial Interests, Institutional, Invited Speaker: MSD, AstraZeneca, Ono Pharma, Novartis, Pfizer, Bristol-Myers Squibb, Loxo, GSK, Lilly, Rakuten Medical, Bayer; Financial Interests, Institutional, Research Grant: Bayer. M.I. Hu: Financial Interests, Steering Committee Member: Eli Lilly & Co; Financial Interests, Institutional, Local PI: Eli Lilly & Co; Other, Co-chair of writing committee for the update of the American Thyroid Association guidelines on systemic therapies for medullary thyroid cancer (non-financial): American Thyroid Association. Y. Lin: Financial Interests, Personal, Full or part-time Employment: Eli Lilly and Company; Financial Interests, Personal, Stocks/Shares: Eli Lilly and Company. P. Maeda: Financial Interests, Personal, Full or part-time Employment: Eli Lilly and Company; Financial Interests, Personal, Stocks/Shares: Eli Lilly and Company. L.J. Wirth: Financial Interests, Personal, Advisory Board: Bayer, Coherus, Eli Lilly, Eisai, Exelixis; Financial Interests, Personal, Other, Consultant: Curie Therapeutics, Morphic Therapeutics, Tome Biosciences; Financial Interests, Personal, Other, DMSC: PDS Biotherapeutics; Financial Interests, Institutional, Steering Committee Member: Novartis, Eli Lilly. J. Capdevila Castillon: Financial Interests, Personal, Invited Speaker: Novartis, Novartis, Pfizer, Ipsen, Exelixis, Bayer, Eisai, Advanced Accelerator Applications, Amgen, Sanofi, Lilly, Merck Serono; Financial Interests, Personal, Advisory Board: Pfizer, Ipsen, Exelixis, Bayer, Eisai, Advanced Accelerator Applications, Amgen, Sanofi, Lilly, Merck Serono; Financial Interests, Personal, Research Grant: Novartis, Pfizer, AstraZeneca, Advanced Accelerator Applications, Eisai, Bayer. All other authors have declared no conflicts of interest.
Invited Discussant LBA3
- Laura D. Locati (Milan, Italy)
LBA4 - Randomized phase III study of first-line selpercatinib versus chemotherapy and pembrolizumab in RET fusion-positive NSCLC
- Herbert Ho Fung Loong (Sha Tin, Hong Kong PRC)
Abstract
Background
Selpercatinib is a highly selective and potent, brain penetrant RET inhibitor, approved for treatment of advanced
Methods
LIBRETTO-431 (NCT04194944) is a randomized, open-label, phase 3 trial comparing first-line selpercatinib vs chemotherapy (cisplatin/carboplatin + pemetrexed) +/- pembrolizumab. The primary endpoint of blinded independent central review (BICR)-assessed PFS was tested first in patients stratified by investigator’s intent to treat with pembrolizumab, if assigned to the control arm, (ITT-pembro) and then in the ITT population. The pre-planned interim efficacy analysis by BICR occurred after 98 PFS events in the ITT-pembro population. Crossover to selpercatinib was allowed following BICR progression on the control arm.
Results
A total of 261 patients were enrolled from 23 countries. Baseline characteristics were balanced across study arms. At a median follow up of approximately 19 months, selpercatinib demonstrated superior PFS vs control in the ITT-pembro (HR: 0.465, 95% CI: 0.309, 0.699; p-value: 0.0002) and ITT populations (HR: 0.482, 95% CI: 0.331, 0.700; p-value: 0.0001). In the ITT-pembro population, median PFS was 24.8 months (95% CI: 16.9, NE) with selpercatinib vs 11.2 months (95% CI: 8.8, 16.8) with control. Clinically meaningful improvements in ORR, DOR, and intracranial response were also observed with selpercatinib vs control. Time to CNS progression was longer with selpercatinib than control (cause-specific HR 0.26; 95% CI: 0.11, 0.59; p=0.0006). Adverse events observed with selpercatinib and the control arm were generally consistent with those previously reported.
Conclusions
Selpercatinib achieved a statistically significant and clinically meaningful improvement in PFS compared to chemotherapy + pembrolizumab in advanced
Clinical trial identification
NCT04194944.
Editorial acknowledgement
Justin Williams, employee of Eli Lilly and Company, provided critical analysis and input with his medical writing assistance.
Legal entity responsible for the study
Eli Lilly and Company.
Funding
Eli Lilly and Company.
Disclosure
H.H.F. Loong: Financial Interests, Institutional, Invited Speaker: Boehringer-Ingelheim, MSD; Financial Interests, Personal, Invited Speaker: Eli Lilly, Illumina, Bayer, Guardant Health; Financial Interests, Personal, Advisory Board: Novartis, Takeda. K. Goto: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical Co., Ltd., Amgen K.K., Takeda Pharmaceutical Co., Ltd., Eli Lilly Japan K.K., Amgen Inc., Amoy Diagnosties Co.,Ltd., AstraZeneca K.K., Bayer HealthCare Pharmaceuticals Inc., Boehringer Ingelheim Japan, Inc., Bristol-Myers Squibb K.K., DAIICHI SANKYO Co., Ltd., Eisai Co., Ltd., Guardant Health Inc., Merck Biopharma Co., Ltd., Novartis Pharma K.K., Ono Pharmaceutical Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Thermo Fisher Scientific K.K., Merck Biopharma Co., Ltd., Taiho Pharmaceutical Co., Ltd.; Financial Interests, Personal, Advisory Board: Janssen Pharmaceutical K.K.; Financial Interests, Personal, Expert Testimony: Medpace Japan K.K.; Financial Interests, Personal and Institutional, Funding: Amgen Inc., Amgen K.K., AstraZeneca K.K., Boehringer Ingelheim Japan, Inc., Bristol-Myers Squibb K.K., Chugai Pharmaceutical Co., Ltd., DAIICHI SANKYO Co., Ltd., Eisai Co., Ltd., Eli Lilly Japan K.K., Haihe Biopharma Co., Ltd., Ignyta,Inc., Janssen Pharmaceutical K.K., KISSEI PHARMACEUTICAL CO., LTD., Kyowa Kirin Co., Ltd., Loxo Oncology, Inc., MEDICAL BIOLOGICAL LABORATORIES CO., LTD., Merck Biopharma Co., Ltd., Merus N.V., MSD K.K., Ono Pharmaceutical Co., Ltd., Pfizer Japan Inc., Sumitomo Dainippon Pharma Co., Ltd., Spectrum Pharmaceuticals, Inc., Sysmex Corporation., Taiho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Turning Point Therapeutics,Inc., Amgen Astellas BioPharma K.K., Bayer Yakuhin, Ltd., Blueprint Medicines Corporation., Life Technologies Japan Ltd., NEC Corporation., Novartis Pharma K.K.; Non-Financial Interests, Member: American Society of Clinical Oncology, The Japan Lung Cancer Society, Japanese Society of Medical Oncology, The Japanese Cancer Association. B.J. Solomon: Financial Interests, Institutional, Advisory Board: AstraZeneca, Novartis, Merck, Bristol Myers Squibb; Financial Interests, Personal, Invited Speaker: Pfizer, AstraZeneca, Roche/Genentech; Financial Interests, Personal, Advisory Board: Amgen, Roche-Genentech, Eli Lilly, Takeda, Janssen; Financial Interests, Personal, Full or part-time Employment, Employed as a consultant Medical Oncologist at Peter MacCallum Cancer Centre: Peter MacCallum Cancer Centre; Financial Interests, Personal, Member of Board of Directors: Cancer Council of Victoria, Thoracic Oncology Group of Australasia; Financial Interests, Personal, Royalties: UpToDate; Financial Interests, Institutional, Invited Speaker, Principal Investigator and Steering committee Chair: Roche/Genentech, Pfizer; Financial Interests, Institutional, Invited Speaker: Novartis. K. Park: Financial Interests, Personal, Advisory Board: JNJ, AstraZeneca, Daiichi Sankyo; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim; Financial Interests, Personal, Other, DMC member: BeiGene, Incyte; Financial Interests, Personal, Other, Advisor/Consultant: Genius, IMBdx; Financial Interests, Personal, Other, Advisor: ABION; Financial Interests, Personal, Stocks/Shares, Stock option: IMBDx, GENIUS. M. Pérol: Financial Interests, Personal, Advisory Board: Roche, AstraZeneca, MSD, BMS, Lilly, Novartis, Takeda, Gritstone, Sanofi, Pfizer, Amgen, JANSSEN, GSK, ESAI, IPSEN; Financial Interests, Personal, Invited Speaker: Roche, AstraZeneca, MSD, BMS, BOEHRINGER INGELHEIM, Takeda, Illumina, Pfizer, Medscape, Roche; Financial Interests, Institutional, Research Grant: AstraZeneca, Roche, Takeda, Boehringer Ingelheim; Financial Interests, Personal, Other, DMSB: Roche. E. Arriola: Financial Interests, Personal, Advisory Board: Roche, Boehringer Ingelheim, Lilly; Financial Interests, Personal, Invited Speaker: Takeda, MSD, AstraZeneca, BMS, Thermo Fisher Scientific, Guardant Health, Pfizer; Financial Interests, Personal, Other, Co-founder: Trialing Health; Financial Interests, Institutional, Research Grant: AstraZeneca. S. Novello: Financial Interests, Personal, Invited Speaker: AZ, MSD, Eli Lilly, Novartis, Beigene, Amgen; Financial Interests, Personal, Advisory Board: BI, BMS, Pfizer, Takeda, Roche, Sanofi, Amgen; Financial Interests, Institutional, Invited Speaker, IIT: MSD, BI; Non-Financial Interests, Leadership Role, president of this european advocacy: WALCE. A. Ardizzoni: Financial Interests, Personal, Invited Speaker, Honoraria for lectures: BMS, AstraZeneca, MSD; Non-Financial Interests, Personal, Advisory Board: Roche, AstraZeneca, BMS, Sanofi, Eli Lilly and Company. M. Mak: Financial Interests, Personal, Invited Speaker: Roche, MSD, Sanofi, Takeda, AstraZeneca; Financial Interests, Personal, Expert Testimony: Eli Lilly, Jassen. F.C. Santini: Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Advisory Board: Lilly. A. Drilon: Financial Interests, Personal, Advisory Board: Ignyta/Genentech/Roche, Loxo/Bayer/Lilly, Takeda/Ariad/Millennium, TP Therapeutics, AstraZeneca, Pfizer, Blueprint Medicines, Helsinn, BeiGene, BerGenBio, Hengrui Therapeutics, Exelixis, Tyra Biosciences, Verastem Oncology, MORE Health, AbbVie, 14ner/Elevation Oncology, Remedica Ltd., ArcherDX, Monopteros, Novartis, EMD Serono, Melendi, Liberum, Repare RX, Amgen, Janssen, EcoR1, Monte Rosa; Financial Interests, Personal, Other, CME: Medscape, Onclive, PeerVoice, Physicians Education Resources, Targeted Oncology, Research to Practice, PeerView Institute, Paradigm Medical Communications, WebMD, MJH Life Sciences, Med Learning, Imedex, Answers in CME, Medscape, Clinical Care Options, AiCME; Financial Interests, Personal, Other, CME, Consulting: Axis; Financial Interests, Personal, Other, Consulting: Nuvalent, Merus, EPG Health, mBrace, Harborside Nexus, Ology, TouchIME, Entos, Treeline Bio, Prelude, Applied Pharmaceutical Science, Inc; Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical, Remedica Ltd, RV More; Financial Interests, Personal, Stocks/Shares: Treeline Biosciences; Financial Interests, Personal, Royalties: Wolters Kluwer; Financial Interests, Personal, Other, stocks: mBrace; Financial Interests, Institutional, Funding, Research funding: Pfizer, Exelixis, PharmaMar, GSK, Teva, Taiho; Financial Interests, Personal, Funding, Research: Foundation Medicine; Non-Financial Interests, Member: ASCO, AACR, IASLC; Other, Food/Beverage: Merck, PUMA, Merus; Other: Boehringer Ingelheim. 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. H. Han: Financial Interests, Personal, Full or part-time Employment: Eli Lilly and Company; Financial Interests, Personal, Stocks/Shares: Eli Lilly and Company. M. Uh: Financial Interests, Personal, Full or part-time Employment: Eli Lilly and Company; Financial Interests, Personal, Stocks/Shares: Eli Lilly and Company. T. Puri: Financial Interests, Personal, Full or part-time Employment, Full time employee of Eli Lilly and Company: Eli Lilly and Company; Financial Interests, Personal, Stocks/Shares, Full time employee of Eli Lilly and Company with stock options: Eli Lilly and Company. V. Ilaria: Financial Interests, Personal, Full or part-time Employment: Eli Lilly and Company - Indianapolis, IN; Financial Interests, Personal, Stocks/Shares: Eli Lilly and Company - Indianapolis, IN. C. Zhou: Financial Interests, Personal, Invited Speaker, Honoraria: Eli Lily, Roche, Sanofi, Qilu Pharma, Hengrui, Innovent Biologics, C-Stone, LUYE Pharma, TopAlliance Biosciences Inc; Financial Interests, Personal, Invited Speaker, BI: BI; Financial Interests, Personal, Invited Speaker, MSD: MSD; Financial Interests, Personal, Advisory Board, Advisor: Amoy Diagnositics. All other authors have declared no conflicts of interest.
LBA5 - Amivantamab plus chemotherapy vs chemotherapy as first-line treatment in EGFR Exon 20 insertion-mutated advanced non-small cell lung cancer (NSCLC): Primary results from PAPILLON, a randomized phase III global study
- Nicolas Girard (Paris, France)
Abstract
Background
Amivantamab (ami) is an EGFR-MET bispecific antibody with immune cell–directing activity. Ami combined with carboplatin/pemetrexed (ami-chemo) demonstrated safety and antitumor activity in the phase 1 CHRYSALIS study. PAPILLON (NCT04538664) evaluated ami-chemo vs chemo in first-line
Methods
Treatment-naïve pts were randomized 1:1 to ami-chemo or chemo. The primary endpoint was progression-free survival (PFS) by blinded independent central review. Secondary endpoints included objective response rate (ORR), PFS after first subsequent therapy (PFS2), overall survival (OS), and safety. Crossover to ami monotherapy was allowed for the chemo arm upon progression.
Results
Overall, 308 pts were randomized (ami-chemo, 153; chemo, 155); median age was 61/62 years, 56/60% female, 64/59% Asian, and 23/23% with history of brain metastases for ami-chemo/chemo, respectively. At median follow-up of 14.9 months, the median PFS was 11.4 months (95% CI, 9.8–13.7) for ami-chemo vs 6.7 months (95% CI, 5.6–7.3) for chemo (hazard ratio [HR], 0.40; 95% CI, 0.30–0.53;
Conclusions
Among pts with
Clinical trial identification
NCT04538664.
Editorial acknowledgement
Medical writing assistance was provided by Katharine Fang, PhD (Janssen Global Services LLC), with support from Claire E. Brady, PharmD and Jessica Swanner, PhD (Lumanity Communications Inc) and funded by Janssen Global Services LLC.
Legal entity responsible for the study
Janssen Pharmaceuticals.
Funding
Janssen Pharmaceuticals.
Disclosure
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 Ingelheim, 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. K. Park: Financial Interests, Personal, Advisory Board: AstraZeneca, Lilly, Ono Pharmaceutical, Bristol Myers Squibb, MSD, Blueprint Medicines, Amgen, Merck KGaA, Loxo, AbbVie, Daiichi Sankyo, Boehringer Ingelheim, Johnson & Johnson, Eisai, Puma Biotechnology; Financial Interests, Personal, Speaker’s Bureau: Boehringer Ingelheim; Financial Interests, Personal, Research Grant: AstraZeneca, MSD Oncology. 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. L. Paz-Ares: Financial Interests, Personal, Advisory Board, Speaker fees: Roche, MSD, BMS, AstraZeneca, Lilly, PharmaMar, Beigene, Daiichi, Medscape, PER; Financial Interests, Personal, Advisory Board: Merck Serono, Pfizer, Bayer, Amgen, Janssen, GSK, Novartis, Takeda, Sanofi, Mirati; Financial Interests, Personal, Other, Board member: Genomica, Altum sequencing; Financial Interests, Institutional, Coordinating PI: Daiichi Sankyo, AstraZeneca, Merck Sharp & Dohme corp, BMS, Janssen-cilag international NV, Novartis, Roche, Sanofi, Tesaro, Alkermes, Lilly, Takeda, Pfizer, PharmaMar; Financial Interests, Personal, Coordinating PI: Amgen; Financial Interests, Other, Member: AACR, ASCO, ESMO; Financial Interests, Other, Foundation Board Member: AECC; Financial Interests, Other, President.ASEICA( Spanish Association of Cancer Research ): ASEICA; Financial Interests, Other, Foundation president: ONCOSUR; Financial Interests, Other, member: Small Lung Cancer Group. S. Cheng: Financial Interests, Personal, Advisory Board: Merck, AstraZeneca. M. Thiagarajan: Financial Interests, Personal, Writing Engagement: Janssen Global Services LLC; Financial Interests, Personal, Member of Board of Directors: Malaysian Oncological Society. J.W. Goldman: Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Advisory Board: Genentech, Eli Lilly, Janssen, AbbVie, Gritstone; Financial Interests, Institutional, Coordinating PI: AstraZeneca, Eli Lilly; Financial Interests, Institutional, Local PI: Genentech, Janssen, BMS, AbbVie. J.K. Sabari: Financial Interests, Personal, Advisory Board: AstraZeneca, Genentech, Janssen, Pfizer, Regeneron, Sanofi Genzyme, Takeda, Mirati Therapeutics. R.E. Sanborn: Financial Interests, Personal, Advisory Board: AstraZeneca, EMD Serono, Daiichi Sankyo, Lilly Oncology, Janssen Oncology, Macrogenics, Sanofi Aventis, Regeneron, Mirati Therapeutics, GSK, G1 Therapeutics; Financial Interests, Personal, Invited Speaker: Illumina; Financial Interests, Personal, Steering Committee Member: GSK, Janssen Oncology; Financial Interests, Institutional, Funding, Funding for investigator-sponsored trial: Merck, AstraZeneca; Financial Interests, Institutional, Other, Institutional research support: BMS; Financial Interests, Institutional, Funding, Clinical trial funding: Jounce. A.S. Mansfield: Financial Interests, Institutional, Research Grant: Novartis, Verily; Financial Interests, Institutional, Speaker, Consultant, Advisor: Rising Tide – grant reviewer, TRIPTYCH Health Partners Expert Think Tank, Janssen - steering committee, BeiGene, Chugai Pharmaceutical Co Ltd (Roche), Ideology Health LLC (formerly Nexus Health Media) - moderator, AXIS Medical Education, Inc. – CME presentation, Johnson & Johnson Global Services – steering committee, Intellisphere LLC (OncLive Summit Series) – CME presentation, Answers in CME – CME presentation, Immunocore - presentation; Financial Interests, Personal, Speaker, Consultant, Advisor: Antoni van Leeuwenhoek Kanker Instituut – CME presentation, University of Miami Int’l Mesothelioma Symposium – speaker; Financial Interests, Personal, Other, Travel: Shanghai Roche; Financial Interests, Institutional, Advisory Board: AbbVie Advisory Board, AstraZeneca Advisory Board, Bristol Myers Squibb Advisory Board, Genentech/Roche Advisory Board, Takeda Oncology; Non-Financial Interests, Personal, Member of Board of Directors: Mesothelioma Applied Research Foundation, Friends of Patan Hospital; Financial Interests, Personal, Research Funding, Study funding, article processing charges: Bristol Myers Squibb. J. Hung: Financial Interests, Personal, Speaker, Consultant, Advisor: AstraZeneca, Roche, OnO Pharma, Eli Lilly and Company, Takeda, Boehringer Ingelheim, Pfizer, Chugai, Novartis, Janssen Pharma. S. Popat: Financial Interests, Personal, Advisory Board: Boehringer Ingelheim, Novartis, Amgen, Janssen, Daiichi Sankyo, AstraZeneca, Bayer, BMS, Blueprint, Merck Serono, Guardant Health, Beigene, Takeda, Lilly, Roche, Turning Point Therapeutics, GSK, MSD, Pfizer, Sanofi, EQRx; Financial Interests, Personal, Invited Speaker: Medscape, VJ Oncology; Financial Interests, Personal, Other, Journal Deputy Editor, Lung Cancer: Elsevier; Financial Interests, Institutional, Other, Sub-investigator: Amgen; Financial Interests, Institutional, Coordinating PI: Ariad, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Takeda, Turning Point Therapeutics, Roche, Janssen, BMS, Lilly; Financial Interests, Institutional, Local PI: AstraZeneca, Roche, GSK, Trizel; Financial Interests, Institutional, Other, Sub-Investigator: MSD, Blueprint; Financial Interests, Institutional, Research Grant: Guardant Health; Non-Financial Interests, Leadership Role, Chair of Steering Committee, Unpaid: British Thoracic Oncology Group; Non-Financial Interests, Officer, Thoracic Faculty, Unpaid: European Society of Medical Oncology; Non-Financial Interests, Leadership Role, Foundation Council Member, Unpaid: European Thoracic Oncology Platform; Non-Financial Interests, Advisory Role, Mesothelioma Task-force Member, Unpaid: International Association for the Study of Lung Cancer; Non-Financial Interests, Member of Board of Directors, Unpaid: Mesothelioma Applied Research Foundation; Non-Financial Interests, Advisory Role, Honorary Clinical Advisor, Unpaid: ALK Positive UK; Non-Financial Interests, Advisory Role, Research Advisory Group Member, Unpaid: Ruth Strauss Foundation; Non-Financial Interests, Advisory Role, Scientific Adivsory Board Member, Unpaid: Lung Cancer Europe. J. Dias: Financial Interests, Personal, Advisory Board: AstraZeneca, Merck Sharp and Dohme; Financial Interests, Personal, Invited Speaker: Amgen, AstraZeneca, Janssen, Roche, Sanofi, Takeda; Financial Interests, Institutional, Other, Local subinvestigator: AbbVie, AstraZeneca, Beigene, Daiichi Sankyo, GSK, Lilly, Novartis, Regeneron, Sanofi, Takeda, Xcovery; Financial Interests, Institutional, Local PI: Amgen, Bristol-Myers Squibb, Debiopharm, Incyte Corporation, Ipsen, Janssen, Merck, Merck Sharp and Dohme, Roche; Other, Financial support for participation in scientific events: Amgen, Janssen. A. Bhattacharya: Financial Interests, Personal, Full or part-time Employment: Janssen. T. Agrawal: Financial Interests, Personal, Full or part-time Employment: Janssen. M. Shreeve: Financial Interests, Personal, Full or part-time Employment: Janssen; Financial Interests, Personal, Stocks or ownership: Johnson and Johnson. R.E. Knoblauch: Financial Interests, Personal, Full or part-time Employment: Janssen; Financial Interests, Personal, Stocks or ownership: Johnson and Johnson. C. Zhou: Financial Interests, Personal, Invited Speaker, Honoraria: Eli Lily, Roche, Sanofi, Qilu Pharma, Hengrui, Innovent Biologics, C-Stone, LUYE Pharma, TopAlliance Biosciences Inc; Financial Interests, Personal, Invited Speaker, BI: BI; Financial Interests, Personal, Invited Speaker, MSD: MSD; Financial Interests, Personal, Advisory Board, Advisor: Amoy Diagnositics. All other authors have declared no conflicts of interest.
Invited Discussant LBA4 and LBA5
- Benjamin Besse (Villejuif, France)