Bendell, Johanna
LoRusso, Patricia
Overman, Michael http://orcid.org/0000-0001-5377-135X
Noonan, Anne M. http://orcid.org/0000-0001-8083-8492
Kim, Dong-Wan http://orcid.org/0000-0001-5124-7132
Strickler, John H. http://orcid.org/0000-0001-7579-1175
Kim, Sang-We
Clarke, Stephen
George, Thomas J. http://orcid.org/0000-0002-6249-9180
Grimison, Peter S. http://orcid.org/0000-0002-2653-1657
Barve, Minal
Amin, Manik http://orcid.org/0000-0001-8467-6152
Desai, Jayesh
Wise-Draper, Trisha http://orcid.org/0000-0002-7279-4028
Eck, Steven
Jiang, Yu
Khan, Anis A. http://orcid.org/0000-0001-8262-3022
Wu, Yuling
Martin, Philip
Cooper, Zachary A. http://orcid.org/0000-0003-1059-0940
Elgeioushi, Nairouz
Mueller, Nancy
Kumar, Rakesh http://orcid.org/0000-0002-4627-3667
Patel, Sandip Pravin
Article History
Received: 2 November 2022
Accepted: 19 March 2023
First Online: 5 April 2023
Declarations
:
: J. Bendell reports research funding (to institution) from Gilead, Genentech/Roche, BMS, Five Prime, Lilly, Merck, MedImmune, Celgene, EMD Serono, Taiho, Macrogenics, GSK, Novartis, OncoMed, LEAP, TG Therapeutics, AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, Bayer, Incyte, Apexigen, Koltan, SynDevRex, Forty Seven, AbbVie, Array, Onyx, Sanofi, Takeda, Eisai, Celldex, Agios, Cytomx, Nektar, ARMO, Boston Biomedical, Ipsen, Merrimack, Tarveda, Tyrogenex, Oncogenex, Marshall Edwards, Pieris, Mersana, Calithera, Blueprint, Evelo, FORMA, Merus, Jacobio, Effector, Novocare, Arrys, Tracon, Sierra, Innate, Arch Oncology, Prelude Oncology, Unum Therapeutics, Vyriad, Harpoon, ADC, Amgen, Pfizer, Millennium, ImClone, Acerta Pharma, Rgenix, Bellicum, Gossamer Bio, Arcus Bio, Seattle Genetics, Tempest Therapeutics, Shattuck Labs, Synthorx, Inc., Revolution Medicines, Inc., Bicycle Therapeutics, Zymeworks, Relay Therapeutics, Scholar Rock, NGM Biopharma, Stemcentrx, BeiGene, CALGB, Cyteir Therapeutics, Foundation Bio, Innate Pharma, Morphotex, OncXerna, NuMab, AtlasMedx, Treadwell Therapeutics, IGM Biosciences, Mabspace, Hutchinson MediPharma, REPARE Therapeutics, NeoImmune Tech, Regeneron, and PureTech Health; consultancy/advisory role (to institution) with Gilead, Genentech / Roche, BMS, Five Prime, Lilly, Merck, MedImmune, Celgene, Taiho, Macrogenics, GSK, Novartis, OncoMed, LEAP, TG Therapeutics, AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, Bayer, Incyte, Apexigen, Array, Sanofi, ARMO, Ipsen, Merrimack, Oncogenex, FORMA, Arch Oncology, Prelude Therapeutics, Phoenix Bio, Cyteir, Molecular Partners, Innate, Torque, Tizona, Janssen, Tolero, Amgen, Seattle Genetics, Moderna Therapeutics, Tanabe Research Laboratories, BeiGene, Continuum Clinical, Agios, Bicycle Therapeutics, Relay Therapeutics, Evelo, Pfizer, Samsung Bioepios, and Fusion Therapeutics; food/beverage/travel from Gilead, Genentech / Roche, BMS, Lilly, Merck, MedImmune, Celgene, Taiho, Novartis, OncoMed, Boehringer Ingelheim, ARMO, Ipsen, Oncogenex, and FORMA. P. LoRusso reports advisory boards with AbbVie, GenMab, Genentech, CytomX, Takeda, Cybrexa, Agenus, IQVIA, TRIGR, Pfizer, ImmunoMet, Black Diamond, GlaxoSmithKline, QED Therapeutics, AstraZeneca, EMD Serono, Shattuck, Astellas, Salarius, Silverback, MacroGenics, Kyowa Kirin Pharmaceutical Development, Kineta, Inc., Zentalis Pharmaceuticals, Molecular Templates, ABL Bio, STCube Pharmaceuticals, Bayer, I-Mab, Seagen, ImCheck, Relay Therapeutics, Stemline, Compass BADX, Mekanist, and Mersana Therapeutics; consultancy for I-Mab, SK Life Science, and SOTIO; membership on a Data Safety Monitoring Board or Committee for Agios, Five Prime, Halozyme, and Tyme; and membership of the imCORE Alliance for Genentech / Roche. M. Overman reports consulting for Phanes Therapeutics, Takeda Pharmaceuticals, Ipsen Biopharmaceuticals, Pfizer, Merck, GlaxoSmithKline, Promega, 3D Medicine, Nouscom, Gritstone, Tempus, and Roche; research funding from Roche, Takeda, Merck, BMS, AstraZeneca, and Nouscom. A. M. Noonan reports being a paid advisory board member for Eisai. D.-W. Kim reports travel expenses/accommodation from Amgen and Daiichi Sankyo and research grants/funding (to institution) from Alpha Biopharma, AstraZeneca, Boehringer-Ingelheim, Hanmi, Janssen, Merus, Mirati Therapeutics, MSD, Novartis, Ono Pharmaceutical, Pfizer, Genentech / Roche, Takeda, TP Therapeutics, Xcovery, and Yuhan. J.H. Strickler reports a consultant or advisory role for AbbVie, AstraZeneca, Bayer, GSK, Inivata, Mereo Biopharma, Natera, Pfizer, Seagen, Silverback Therapeutics, and Viatris and research funding from or contracted research for AstraZeneca, Bayer, Erasca, Seagen, Amgen, Daiichi Sankyo, Gossamer Bio, AStar D3, Sanofi, Genentech / Roche, Curegenix, Nektar, AbbVie, and Silverback Therapeutics. S. Clarke reports personal fees for advisory boards and speaker fees from AstraZeneca. T. J. George reports consultancy for Tempus Labs, Inc, and Pfizer, and institutional research funding from Bristol Myers Squibb, Merck, AstraZeneca, Lilly, Bayer, Incyte, Ipsen, Seagen, Genentech, Astellas, GlaxoSmithKline, Amgen, and OncoC4. P. S. Grimison reports study site funding for clinical trial participation from MedImmune/AstraZeneca. T. Wise-Draper reports grants from Merck & Co (clinical trial support), Janssen, Bristol Myers Squibb, and GlaxoSmithKline, and consultancy for Merck & Co, Caris Life Sciences (Molecular Tumor Board Consultant), Exicure, Rakuten, and Shattuck Labs. S. Eck reports employment by and stock ownership in AstraZeneca. Y. Jiang reports employment by and stock ownership in AstraZeneca. A. A. Khan reports employment by and stock ownership in AstraZeneca, and a patent pending of relevance to this work. Y. Wu reports employment by and stock ownership in AstraZeneca. P. Martin reports employment by and stock ownership in AstraZeneca. Z. A. Cooper reports employment by and stock ownership in AstraZeneca. N. Elgeioushi reports employment by and stock ownership in AstraZeneca. N. Mueller reports employment by and stock ownership in AstraZeneca. R. Kumar reports employment by and stock ownership in AstraZeneca, and a patent pending of relevance to this work. S. P. Patel reports personal fees for advisory board participation for AstraZeneca, Bristol Myers Squibb, Eli Lilly, Illumina, Paradigm, Rakuten, and Tempus; research grants/funding (to institution) from AstraZeneca, Bristol Myers Squibb, Eli Lilly, Fate Therapeutics, Genocea, Merck, Novartis, Pfizer, Roche/Genentech, and Tempus. No disclosures were reported by the other authors.
: The study protocol was approved by the institutional review board or ethics committee for each participating center, and the study was run in accordance with ethical principles originating in the Declaration of Helsinki and consistent with the International Conference on Harmonization guidelines on Good Clinical Practice, as well as applicable regulatory requirements.
: All patients provided written, informed consent to participate in the study, including consent to provide archived tumor specimens from core biopsy or larger resection < 3 years from screening for biomarker studies. All patients were encouraged to provide consent for paired pretreatment and on-treatment tumor biopsies where clinically feasible.