Abstract 96P
Background
Zelenectide pevedotin (zele, formerly BT8009) is a Bicycle® Toxin Conjugate (BTC®) comprised of a bicyclic peptide targeting Nectin-4 conjugated to MMAE. NECTIN4 amp has been shown to be a predictive biomarker for response to enfortumab vedotin in metastatic urothelial cancer (Klümper et al., 2024), and this post-hoc analysis assesses the utility of NECTIN4 amp as a predictor of zele response in NSCLC pts.
Methods
Zele is being evaluated in the ongoing Ph 1/2 study BT8009-100/Duravelo-1 (NCT04561362) for safety and efficacy in pts with advanced solid tumors associated with Nectin-4 expression. This analysis focuses on NSCLC pts who had baseline tissue samples available to test for NECTIN4 amp by fluorescence in-situ hybridization. NECTIN4 amp was defined as a ratio of NECTIN4:CEN1 of ≥2.0. Anti-tumor activity was assessed per RECIST v1.1 by investigator.
Results
As of 13 Sep 2024, 40 heavily pretreated pts with NSCLC were enrolled. At baseline, NSCLC pts had a median age of 63.5 (34–80), median prior lines of therapy of 3 (1–8), and ECOG of 0 (25%) or 1 (75% each). Twenty-nine pts with NSCLC from dose escalation/expansion and treated with a starting dose of 5 mg/m2 or higher were efficacy evaluable; 3 achieved partial response (PR) resulting in an ORR of 10.3%. Seventeen pts were tested for NECTIN4 amp, of those, 6 were positive (35.3%), and 5 of them were efficacy evaluable. Of these, 2 achieved a confirmed PR with an ORR of 40.0% (5.3, 85.3), and the remaining 3 had stable disease (disease control rate 100.0%). Of the NECTIN4 non-amp pts, 8 were efficacy evaluable and none had a response. Safety and tolerability of zele in the NSCLC population was similar to a previously reported cohort of bladder cancer pts (Reig et al., 2024). Fatigue, nausea, and diarrhea were the most common AEs. Grade ≥3 zele-related adverse events (AE) occurred in 37.5% of pts, and Grade ≥3 zele-related serious adverse events occurred in 12.5% of pts.
Conclusions
NECTIN4 amplification appears to showpredictive clinical utility in identifying NSCLC pts with enhanced response to zelenectide pevedotin, with an ORR of 40.0% in NECTIN4 amp NSCLC pts. Further exploration of zele and NECTIN4 amp stratification strategies in NSCLC pts is warranted.
Clinical trial identification
NCT04561362.
Legal entity responsible for the study
BicycleTx, Ltd.
Funding
BicycleTx, Ltd.
Disclosure
L. Verlingue: Financial Interests, Personal, Stocks/Shares, CEO of Resolved dedicated to treatment approval prediction: Resolved; Financial Interests, Institutional, Research Grant: Bristol Myers Squibb; Financial Interests, Institutional, Funding, Contract for bioinformatic analysis: Pierre Fabre, Servier; Non-Financial Interests, Personal, Advisory Role: Klineo; Non-Financial Interests, Institutional, Proprietary Information, As part of the Drug Development Department (DITEP) of Gustave Roussy and of the Phase 1 unit of Centre Léon Bérard, as medical doctor, LV report being: Principal/sub-Investigator of Clinical Trials for AbbVie, Adaptimmune, Aduro Biotech, Agios Pharmaceuticals, Amgen, Argen-X Bvba, Arno Therapeutics, Astex Pharmaceuticals, AstraZeneca Ab, Aveo, Basilea Pharmaceutica International Ltd, Bayer Healthcare Ag, Bbb Technologies Bv, Beigene, Blueprint Medicines, Boehringer Ingelheim, Boston Pharmaceuticals, Bristol Myers Squibb, Ca, Celgene Corporation, Chugai Pharmaceutical Co, Clovis Oncology, Cullinan-Apollo, Daiichi Sankyo, Debiopharm, Eisai, Eisai Limited, Eli Lilly, Exelixis, Faron Pharmaceuticals Ltd, Forma Tharapeutics, Gamamabs, Genentech, GSK, H3 Biomedicine, Hoffmann La Roche Ag, Imcheck Therapeutics, Innate Pharma, Institut De Recherche Pierre Fabre, Iris Servier, Janssen Cilag, Janssen Research Foundation, Kura Oncology, Kyowa Kirin Pharm. Dev, Lilly France, Loxo Oncology, Lytix Biopharma A: Pharmas. N. Klümper: Financial Interests, Personal, Invited Speaker: MSD Oncology, Astellas Pharma, Merck KGaA; Financial Interests, Personal, Advisory Board: Astellas Pharma, MSD Oncology, Eisai, Bicycle Therapeutics; Financial Interests, Institutional, Invited Speaker: Bicycle Therapeutics. M. Eckstein: Financial Interests, Personal, Funding: BicycleTx; Financial Interests, Personal, Other, Consulting Fees: AstraZeneca, GenomicHealth, Gilead, Merck, Janssen/J&J, Diaceutics, MSD, BicycleTx; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Janssen/J&J, Diaceutics, Eisai, BicycleTx, Roche, Owkin, Ferring, Merck; Financial Interests, Personal, Expert Testimony: AstraZeneca, GenomicHealth, Gilead, Merck, Janssen/J&J, Diaceutics, MSD, BicycleTx; Financial Interests, Personal, Other, Support for attending meetings and/or travel: AstraZeneca, MSD, Diaceutics, Ferring, Merck, Roche, Janssen/J&J, Astellas, Eisai, BicycleTx; Financial Interests, Personal, Leadership Role: Clinical Advisory Board of BicycleTx, Board of ESUP of the EAU, Board of ISUP of the EAU, Board of BRIDGE Consortium; Financial Interests, Personal, Other, Receipt of equipment, materials, drugs, gifts or other services: STRATIFYER, AstraZeneca/MedImmune, Gilead, Janssen/J&J, Owkin, BicycleTx. J. Braegelmann: Financial Interests, Personal and Institutional, Research Grant: Bayer AG; Non-Financial Interests, Personal, Proprietary Information: Bicycle Therapeutics; Non-Financial Interests, Personal, Product Samples: Takara Bioscience. M. McKean: Financial Interests, Institutional, Other, Consulting: Pfizer, Castle Biosciences, IQVIA, Merck, Moderna; Financial Interests, Institutional, Research Grant: Acentage Pharma Group, Bicycle Therapeutics, Dragonfly Therapeutics, Epizyme, Exelixis, Genentech, GSK, IDEAYA Biosciences, Ikena Oncology, Infinity Pharmaceuticals, Jacobio Pharmaceuticals, Moderna, NBE Therapeutics, Novartis, Oncorus, Plexxicon, Prelude Therapeutics, Regeneron, Sapience Therapeutics, Seattle Genetics, Tizona Therpeutics, TMUNITY Therapeutics, TopAlliance Biosciences, Aadi Biosciences, Alpine Immune Sciences, Arcs Biosciences, Arvinas, ASCO, Astellas, Bayer, BioMed Valley Discoveries, BioNTech, C4 Therapeutics, EMD Serono, Erasca, Foghorn Therapeutics, G1 Therapeutics, Gilead Sciences, ImmVira Pharma, Kechow Pharma, Kezar Life Sciences, Kinnate BioPharma, MedImmune, Mereo BioPharma, Metabomed, Nektar, OncoC4, PACT Pharma, Pfizer, Poseida, Pyramid Biosciences, Scholar Rock, Synthrox, Takeda Pharmaceuticals, Teneobio, Tempest Therapeutics, Xilio, Aulos Bioscienc, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, InconVir, Jazz Pharmaceutical, Krystal Biotech, NucMito Pharmaceuticals, OnKure, Remix Therapeutics. A. Italiano: Financial Interests, Personal, Other, Contracts for services: Bayer, MSD, Merck, AstraZeneca, Roche, Novartis, Ipsen, Daiichi Sankyo; Financial Interests, Personal, Advisory Board: Bayer, MSD, Merck, AstraZeneca, Roche, Novartis, Ipsen, Daiichi Sankyo. L. Carter: Financial Interests, Personal, Other, Consultancy: Bicycle Therapeutics, Boehringer Ingelheim, Athenex; Financial Interests, Personal, Full or part-time Employment, Medical Advisor: Cancer research UK Centre for Drug Development; Financial Interests, Institutional, Invited Speaker: Boehringer Ingelheim, Bicycle Therapeutics, Cellcentric, Eli Lily, Athenex, Lupin Limited, Repare Therapeutics, Cytomx therapeutics, EMD Serono/Merck KGaA, Sierra Oncology, Nurix Therapeutics, ADC Therapeutics, Takeda; Financial Interests, Institutional, Invited Speaker, Funding for delivering commercial trial activity: Genmab. G.S. Falchook: Financial Interests, Institutional, Advisory Board, 2018: FujiFilm; Financial Interests, Institutional, Advisory Board, 7/24/2020, 9/17/2021: Silicon; Financial Interests, Institutional, Advisory Board, 3/10/21: Navire; Financial Interests, Institutional, Advisory Board, 4/22/21: Turning Point; Financial Interests, Institutional, Advisory Board, 10/2/21: Predicine; Financial Interests, Institutional, Advisory Board, 10/26/21: Inspirna; Financial Interests, Institutional, Advisory Board, 10/28/21: Regeneron; Financial Interests, Personal, Advisory Board, 6/2010, 3/2011: EMD Serono; Financial Interests, Institutional, Advisory Board, 1/18/22 and 8/17/22: Jubilant; Financial Interests, Institutional, Advisory Board, 6/4/22: BostonGene; Financial Interests, Institutional, Advisory Board, 9/30/22: AbbVie; Financial Interests, Personal, Invited Speaker, 2019: Total Health Conferencing; Financial Interests, Personal, Invited Speaker, 2020: Rocky Mountain Oncology Society; Financial Interests, Personal, Other, Travel, for work and/or research related to institution, 2015: Bristol Myers Squibb; Financial Interests, Personal, Other, Travel, for work and/or research related to institution, 2011, 2012, 2013: EMD Serono; Financial Interests, Personal, Other, Travel, to present research at a conference (Cholangiocarcinoma Foundation meeting), 2018: Fujifilm; Financial Interests, Personal, Other, Travel, to present research at a conference (ESGO), 2013: Millennium; Financial Interests, Personal, Other, Travel, for work and/or research related to institution, at least once yearly: Sarah Cannon Research Institute (employer); Financial Interests, Personal, Other, Travel, to present research at a conference (WCLC), 2022: Amgen; Financial Interests, Personal, Other, Travel, to present research at a conference (ESMO), 2022: Synthorx/Sanofi; Financial Interests, Institutional, Advisory Board, Scientific advisory board 11/18/22: Teon Therapeutics; Financial Interests, Institutional, Advisory Board, 12/8/22: Merck; Financial Interests, Personal, Invited Speaker, CME presentation about NSCLC and thyroid cancer, 2/20/24: Clinical Care Options; Financial Interests, Personal, Royalties: Wolters Kluwer; Financial Interests, Institutional, Invited Speaker, Unknown end date, before 1/2021: 3-V Biosciences, ARMO/Eli Lilly, Celldex, DelMar, eFFECTOR, Kolltan, miRNA Therapeutics, OncoMed, Precision Oncology, Strategia; Financial Interests, Institutional, Invited Speaker, 12/2019–6/2023: Abbisko; Financial Interests, Institutional, Invited Speaker, ending 4/2019: AbbVie; Financial Interests, Institutional, Invited Speaker, 8/2021 - present: ABL Bio; Financial Interests, Institutional, Invited Speaker, 12/2021–8/2023: Accutar; Financial Interests, Institutional, Invited Speaker: Aileron, Amgen, AstraZeneca, BeiGene, Fujifilm, Jacobio, Jounce, Loxo/Bayer, Merck, Regeneron, Rgenix, Takeda; Financial Interests, Institutional, Invited Speaker, ending 6/2014: American Society of Clinical Oncology, Celgene, EMD Serono, Genmab, MedImmune, National Institutes of Health, Oncothyreon, U.T. MD Anderson Cancer Center, Vegenics; Financial Interests, Institutional, Invited Speaker, 9/2021 - present: Artios, NiKang; Financial Interests, Institutional, Invited Speaker, 4/2019 - present: Bioatla; Financial Interests, Institutional, Invited Speaker, 6/2020 - present: Bioinvent; Financial Interests, Institutional, Invited Speaker, ending 11/2018: Biothera; Financial Interests, Institutional, Invited Speaker, 8/2020 - present: Bicycle; Financial Interests, Institutional, Other, Subinvestigator on a sponsored clinical trial. 3/2022 - present: Black Diamond, Seagen; Financial Interests, Institutional, Invited Speaker, 5/2021 - present: Boehringer Ingelheim, Erasca; Financial Interests, Institutional, Invited Speaker, ending 5/2021: Ciclomed; Financial Interests, Institutional, Invited Speaker, ending 7/2018: Curegenix; Financial Interests, Institutional, Invited Speaker, ending 3/2019: Curis; Financial Interests, Institutional, Invited Speaker, 9/2019 - present: Cyteir, Xencor; Financial Interests, Institutional, Invited Speaker, 11/2019 - present: Daiichi; Financial Interests, Institutional, Invited Speaker, ending 9/2022: Eli Lilly, Tesaro; Financial Interests, Institutional, Invited Speaker, 12/2019 - present: Epizyme; Financial Interests, Institutional, Invited Speaker, ending 10/2023: Exelixis, GSK; Financial Interests, Institutional, Invited Speaker, 7/2021 - present: Freenome, Samumed; Financial Interests, Institutional, Invited Speaker, ending 10/2022: Hutchison MediPharma; Financial Interests, Institutional, Invited Speaker, 10/2020 - present: IGM Biosciences, ImmunoGen/MarcoGenics; Financial Interests, Institutional, Invited Speaker, ending 6/2019: Ignyta; Financial Interests, Institutional, Invited Speaker, ending 9/2019: Incyte; Financial Interests, Institutional, Other, Subinvestigator on a sponsored clinical trial. 04/2022 - present: Jubilant; Financial Interests, Institutional, Invited Speaker, ending 5/2008, when Millennium was purchased by Takeda: Millennium; Financial Interests, Institutional, Invited Speaker, 10/2021–6/2023: Molecular Templates; Financial Interests, Institutional, Invited Speaker, 2/2021 - present: Navire; Financial Interests, Institutional, Invited Speaker, ending 2/2024: Novartis; Financial Interests, Institutional, Invited Speaker, 3/2020–2/2024: Oncorus; Financial Interests, Institutional, Invited Speaker, 3/2020 - present: Poseida; Financial Interests, Institutional, Invited Speaker, 12/2019–2/2024: Prelude; Financial Interests, Institutional, Invited Speaker, 12/2020 - present: PureTech, Silicon; Financial Interests, Institutional, Invited Speaker, 06/2021–06/2023: Pyramid; Financial Interests, Institutional, Invited Speaker, 3/2021 - present: RasCal; Financial Interests, Institutional, Other, Subinvestigator on a sponsored clinical trial. 12/2021 - present: Relay; Financial Interests, Institutional, Invited Speaker, 8/2019 - present: Ribon, Turning Point; Financial Interests, Institutional, Invited Speaker, 7/2020 - present: Sapience; Financial Interests, Institutional, Invited Speaker, 12/2021 - present: Simcha; Financial Interests, Institutional, Other, Subinvestigator on a sponsored clinical trial. 11/2021 - present: Sirnaomics; Financial Interests, Institutional, Invited Speaker, ending 5/2019: Syndax; Financial Interests, Institutional, Invited Speaker, 09/2019–02/2024: Synthorx/Sanofi; Financial Interests, Institutional, Invited Speaker, ending 12/2017: Taiho; Financial Interests, Institutional, Invited Speaker, ending 7/2022: Tarveda; Financial Interests, Institutional, Invited Speaker, 5/2021 - present. TeneoBio was purchased by Amgen.: Teneobio; Financial Interests, Institutional, Invited Speaker, ending 1/2020: Tocagen; Financial Interests, Institutional, Other, Subinvestigator on a sponsored clinical trial. 05/2022–11/2022: Metabomed; Financial Interests, Institutional, Other, Subinvestigator on a sponsored clinical trial. 6/2022 - present: Agenus; Financial Interests, Institutional, Other, Subinvestigator on a sponsored clinical trial. 06/2022 - present: Tallac; Financial Interests, Institutional, Other, Subinvestigator on a sponsored clinical trial. 7/2022 - present: Zhuhai Yufan, Mirati; Financial Interests, Institutional, Other, Subinvestigator on a sponsored clinical trial. 10/2022 - present: Immunitas, Jazz Pharmaceuticals; Financial Interests, Institutional, Other, Subinvestigator on a sponsored clinical trial. 11/2022 - present: Bayer; Financial Interests, Institutional, Invited Speaker, 1/2019 - present: ADC Therapeutics; Financial Interests, Institutional, Other, Subinvestigator on a sponsored clinical trial. 3/2023 - present: Kineta, Roche; Financial Interests, Institutional, Other, Subinvestigator on a sponsored clinical trial. 03/2023 - present: NGM Biopharmaceuticals; Financial Interests, Institutional, Invited Speaker, 4/2023 - present: Tarus; Financial Interests, Institutional, Other, Subinvestigator on a sponsored clinical trial. 05/2023 - present: Pyxis; Financial Interests, Institutional, Other, Subinvestigator on a sponsored clinical trial. 06/2023 - present: Harbour BioMed, Centessa Pharmaceuticals; Financial Interests, Institutional, Invited Speaker, 07/2023 - present: IDEAYA, Tango Therapeutics; Financial Interests, Institutional, Other, Subinvestigator on a sponsored clinical trial. 08/2023 - present: Biomea Fusion; Financial Interests, Institutional, Invited Speaker, 09/2023 - present: Conjupro Biotherapeutics; Financial Interests, Institutional, Other, Subinvestigator on a sponsored clinical trial. 09/2023 - present: Phanes Therapeutics; Financial Interests, Institutional, Other, Subinvestigator on a sponsored clinical trial. 9/2023 - present: Sarah Cannon Development Innovations; Financial Interests, Institutional, Invited Speaker, 10/20/23 - present: Nuvectis Pharma; Financial Interests, Institutional, Other, Subinvestigator on a sponsored clinical trial. 1/20/24 - present: Kura Oncology; Financial Interests, Institutional, Invited Speaker, 1/2024 - present: Eikon Therapeutics. V. Boni: Financial Interests, Personal, Advisory Board: EMD Serono, Janssen; Financial Interests, Personal, Other, IDMC participation: Nanobiotix; Financial Interests, Personal, Full or part-time Employment, DIrector of CLinical Cancer Research, Phase 1 Unit NEXT: NEXT Madrid, Universitary hospital Quiron Salud; Financial Interests, Personal, Stocks/Shares: 1TRIALSP; Non-Financial Interests, Personal, Member: ASCO, SEOM. A. Dowlati: Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, Pfizer. B. Doger de Spéville: Non-Financial Interests, Personal, Principal Investigator: Bicycle therapeutics, Janssen, Immutep, AbbVie, Ascendis, AstraZeneca, BioInvent, Boehringer, Ipsen, Merk, NEC Bio Therapeutics, Novartis, Revolution, Roche, Takeda, Zai Lab, Totus Medicines, BioNTech, Enliven. E. Fontana: Financial Interests, Personal, Invited Speaker: CARIS Life Science, Repair Therapeutics; Financial Interests, Personal, Other, Conference attendance: Sapience Pharma, Seagen, ERASCA; Financial Interests, Personal, Invited Speaker, Conference Attendance: Bicycles Therapeutics; Financial Interests, Personal, Advisory Board: Astellas, Pfizer, Bicycles Therapeutics, BMS; Financial Interests, Personal, Full or part-time Employment: Hospital Corporation of America (HCA) International; Financial Interests, Personal, Officer: EORTC; Financial Interests, Institutional, Invited Speaker: Repair Therapeutics, Bicycle Therapeutics, Artios Pharma, Seagen, Amgen, Nurix Therapeutics, BioNTech SE, Relay Therapeutics, Taiho Pharmaceutical, Pfizer, Roche, Daiichi Sankyo, Gilead Science, Basilea Pharmaceutica, Jiangsu Hengrui Medicine, Mereo Biopharma, HUTCHMED, Merus, Crescendo Biologics, GSK plc, BeiGene, Turning Point Therapeutics, Sapience Pharma, Arcus Bioscience, Exelixis, Nerviano Medica, Elipsees, Deciphera, Ribon Therapeutics, Erasca, PMV Pharma, Takeda, Acerta Pharma, ADC Therapeutics, Array Biopharma, Astellas, Astex, AstraZeneca, Bayer, BluePrint, Boehringer Ingelheim, Calithera, Carrick Therapeutics, Casi Therapeutics, Clovis Oncology, CytomX Therapeutics, EliLilly, Fore Biotherapeutics, G1 Therapeutics, Genentech, H3 Biomedicine, Immunocore, Immunomedics, Incyte, Instil Bio, Iovance, Janssen, Kronos Bio, Lupin Limited, Macrogenics, Menarini, Merck KGaA, MIllenium Pharmaceuticals, MSD, Oncologie, Oxford Vacmedix, Plexxikon, QED Therapeutics, Servier, Synthon Biopharmaceuticals, Tesaro. J. Rodon: Financial Interests, Personal, Advisory Board: Ellipses Pharma, IONCTURA SA, Aadi Bioscience, Envision Pharma, Molecular Partners, Mekanistic, Amgen; Financial Interests, Personal, Other, Consultancy: Clarion Healthcare, Debiopharm, Cullgen, Pfizer, Macrogenics, Oncology One, Columbus Venture Partners, Sardona Therapeutics, Avoro Capital Advisors, Vall d’Hebron Institute of Oncology/Ministero De Empleo Y Seguridad, Chinese University of Hong Kong, Boxer Capital, LLC, Tang Advisors, LLC, Alnylam Pharmaceuticals, Bridgebio Pharma; Financial Interests, Personal, Other, Consultancy/Advisory Board: Monte Rosa Therapeutics, Merus N.V., Incyte; Financial Interests, Institutional, Other, Clinical Research: Novartis, Spectrum Pharmaceuticals, Symphogen, BioAtla, Pfizer, GenMab, CytomX, Kelun-Biotech, Takeda-Millenium, GSK; Financial Interests, Institutional, Other, Research Funding: Blueprint Medicines, Black Diamond, Merck Sharp & Dohme; Financial Interests, Institutional, Research Grant, Research Funding/Clinical Research: Hummingbird, Yingli; Financial Interests, Institutional, Research Grant, Research Funding: Vall d’Hebron Institute of Oncology/Cancer Core Europe; Financial Interests, Institutional, Research Grant, Clinical Research: Bicycle Therapeutics, Taiho, Roche Pharmaceuticals, Merus, Curis, AadiBioscience, Nuvation, ForeBio, BioMed Valley Discoveries, Loxo Oncology, Cellestia, Deciphera, Ideaya, Amgen, Tango Therapeutics, Mirati, Linnaeus Therapeutics, Bayer, Hutchinson MediPharma; Other, Personal, Other: VHIO/Ministero De Empleo Y Seguridad Social; Other, Personal, Other, Travel: European Society for Medical Oncology, Loxo Oncology. L. Demars: Financial Interests, Personal, Full or part-time Employment, Sept 2023-current: Bicycle Therapeutics; Financial Interests, Personal, Other, Support for attending meetings and/or travel: Bicycle Therapeutics, Mersana Therapeutics; Financial Interests, Personal, Stocks/Shares: Bicycle Therapeutics. G. Brown: Financial Interests, Personal, Full or part-time Employment: Bicycle Therapeutics; Financial Interests, Personal, Stocks/Shares: Bicycle Therapeutics; Financial Interests, Personal, Other, Provision of study materials: Bicycle Therapeutics. C. Xu: Financial Interests, Personal, Full or part-time Employment: Bicycle Therapeutics; Financial Interests, Personal, Stocks/Shares: Bicycle Therapeutics. C. Campbell: Financial Interests, Personal, Full or part-time Employment: Bicycle Tx; Financial Interests, Personal, Stocks/Shares: Bicycle Tx; Non-Financial Interests, Personal, Member: AACR. T. Gelb: Financial Interests, Personal, Full or part-time Employment: Bicycle Therapeutics; Financial Interests, Personal, Stocks/Shares: Bicycle Therapeutics. S. Santos: Financial Interests, Personal, Stocks/Shares: Bicycle Therapeutics Stock Options; Financial Interests, Personal, Full or part-time Employment: Bicycle Therapeutics Stock Options. C. Baldini: Financial Interests, Institutional, Advisory Board: BMS; Financial Interests, Institutional, Expert Testimony: MSD; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Institutional, Research Grant: BMS; Financial Interests, Institutional, Invited Speaker: iTeos, AZ, Janssen, Amgen, Bicycle Therapeutics, MSD, Seattle Genetics, Tahio, Pyramid Bioscience, Tango, Roche Genentech; Non-Financial Interests, Personal, Member: ASCO, SIOG, SOFOG, AACR, ESMO.