Miller, Claire
Sommavilla, Roberto
O’Bryant, Cindy L.
Barve, Minal
Dowlati, Afshin
Luke, Jason J.
Khatun, Mahmuda
Morris, Thomas
Cullberg, Marie
Article History
Received: 11 January 2024
Accepted: 30 March 2024
First Online: 20 April 2024
Declarations
:
: C.M., M.K., T.M., and M.C. are employees of AstraZeneca and may hold stocks and/or shares. R.S. was an employee of AstraZeneca at the time the study was conducted. C.L.O. and M.B. have no relevant conflicts of interest to declare. A.D. has received consulting or advisory role fees from AbbVie/Stemcentrx, AstraZeneca, Bayer, Bristol Myers Squibb, G1 Therapeutics, Ipsen, Merck, and Takeda; and has received research funding (to their institution) from AbbVie/Stemcentrx, Amgen, Bayer, Bristol Myers Squibb, EMD Serono, Ipsen, Lilly/ImClone, Mirati Therapeutics, Regeneron, Seattle Genetics, Symphogen, Takeda, Tesaro, and United Therapeutics. J.J.L. has served on data and safety monitoring boards for AbbVie, Agenus, Evaxion, and Immutep; has served on scientific advisory boards for (no stock) 7 Hills, Affivant, BioCytics, Bright Peak, Exo, F-star, Inzen, RefleXion, and Xilio, and (stock) Actym, Alphamab Oncology, Arch Oncology, Duke Street Bio, Kanaph, Mavupharma, NeoTx, Onc.AI, OncoNano, physIQ, Pyxis, Saros, STipe, and Tempest; has provided consultancy (with compensation) for AbbVie, Agenus, Alnylam, AstraZeneca, Atomwise, Bayer, Bristol Myers Squibb, Castle, Checkmate, Codiak, Crown, Cugene, Curadev, Day One, Eisai, EMD Serono, Endeavor, Flame, G1 Therapeutics, Genentech, Gilead, Glenmark, HotSpot, Ikena, Immatics, Immunocore, Incyte, Instil, Inzen, IO Biotech, Janssen, Kadmon, KoBioLabs, Krystal, KSQ, LegoChem, MacroGenics, Merck, Mersana, Nektar, Novartis, Partner, Pfizer, Pioneering Medicines, PsiOxus, Regeneron, Replimune, Ribon, Roivant, Servier, Stingthera, Sumitomo, Synlogic, Synthekine, and Teva; and has received research funding (to their institution, for clinical trials) from AbbVie, Astellas, AstraZeneca, Bristol Myers Squibb, Corvus, Day One, EMD Serono, F-star, Genmab, HotSpot, Ikena, Immatics, Incyte, Kadmon, KAHR, MacroGenics, Merck, Moderna, Nektar, NextCure, Novartis, Numab, Palleon, Pfizer, Replimune, Rubius, Scholar Rock, Servier, Synlogic, Takeda, Trishula, Tizona, and Xencor; and has the following patent: US-11638728 (Microbiome Biomarkers for Anti-PD-1/PD-L1 Responsiveness: Diagnostic, Prognostic and Therapeutic Uses Thereof).
: The study was conducted in accordance with the Declaration of Helsinki, the International Council for Harmonisation Good Clinical Practice guideline, and all applicable local regulations. The institutional review boards or independent ethics committees of all investigational sites approved the protocol.
: All patients provided written consent.