Defining best practices for tissue procurement in immuno-oncology clinical trials: consensus statement from the Society for Immunotherapy of Cancer Surgery Committee.

Immunotherapy is now a cornerstone for cancer treatment, and much attention has been placed on the identification of prognostic and predictive biomarkers. The success of biomarker development is dependent on accurate and timely collection of biospecimens and high-quality processing, storage and shipping. Tumors are also increasingly used as source material for the generation of therapeutic T cells. There have been few guidelines or consensus statements on how to optimally collect and manage biospecimens and source material being used for immunotherapy and related research. The Society for Immunotherapy of Cancer Surgery Committee has brought together surgical experts from multiple subspecialty disciplines to identify best practices and to provide consensus on how best to access and manage specific tissues for immuno-oncology treatments and clinical investigation. In addition, the committee recommends early integration of surgeons and other interventional physicians with expertise in biospecimen collection, especially in clinical trials, to optimize the quality of tissue and the validity of correlative clinical studies in cancer immunotherapy.

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Competing interests: BG is a consultant for Quest Imaging and a speaker for Castle Biosciences. PKA has partner salary from Pfizer. GB has sponsored research agreements with Takeda Oncology, Olink Proteomics, and Palleon, honorarium from Novartis, and consulting for NW Biotherapeutics. SB is a consultant for BMS. LHB is a consultant for StemImmune/Calidi, NextCure, Replimmune, Western Oncolytics, Torque Therapeutics, Khloris, Pyxis, Cytomix, and Roche-Genentech. PEF is a consultant for Monteris Medical. RLF is a consultant for Aduro Biotech, Amgen, Astra-Zeneca/Medimmune, Bain Capital Life Sciences, BMS, EMD Serono, GSK, Iovance, Lilly, MacroGenics, Merck, Nanobiotx, Numab Therapeutics, Oncorus, Ono Pharmaceutcal Co., Pfizer, PPD, Regeneron, Tesaro, Torque Therapeutics, TTMS, and VentiRx Pharmaceuticals; has contracted research agreements with Astra-Zeneca/Medimmune, BMS, Merck, Tesaro, and TTMS, has partner consulting for Janssen, Lilly, Scibase, DermTech, BMS, and Pfizer, and has partner contracted research agreements with Regeneron, Janssen, BMS, Abbvie, BI, Castle Biosciences and Lilly.YF has relationships with Imagene, Merck, Eureka and Surgamo, and partner interest in Pfizer. MLim is a consultant for Tocagen, VBI and Strykes, and receives research funding from Arbor, BMS and Biohaven. MLotze receives salary from Nurix, Inc., royalty from Cellatrope, has IP rights in Intrexon, consults for Myst, Instill, Checkmate, Carisma and Surface Oncology, and has ownership interest in iRepertoire. HM has contracted research with Puma Biotechnology. RIN is a consultant for Novartis, Castle Biosciences, and Sanofi-Granzyme and has contracted research with Regeneron and Castle Biosciences. AO is a cofounder of Tactiva Therapeutics, Inc., and receives research support from AstraZeneca and Tesaro. SP is a consultant for Abbvie, Astra-Zeneca, Cue Biopharma, Fusion Biopharma, Merck, Newlink Genetics, Oncolys Biopharma, Oncosec, Replimmune and Sensei Bio, contracted research with Abbvie, Astra-Zeneca, Cue Biopharma, Sensei Bio and Tesaro, and investigator-initiated trials with ASTX Pharmaceuticals, Astra-Zeneca, Cue Biopharma, ImmuneDesign and Merck. SAR has patents held by the NCI and cooperative research agreements with Kite, Iovance and Ziopharm. CLS is a consultant for Celldex, CureVac and Castle Biosciences, and has institutional support from Celldex, Polynoma, GSK, Merck, 3M, Theraclion and Immatics. VKS is a consultant for Array, BMS, Merck, Novartis, Pfizer, Polynoma, Regeneron and Replimmune. JBS is on the advisory board of ABL Bio and is the scientific founder of Indapta Therapeutics. ST is a consultant for TVM Life Science, received honoraria from Astra-Zeneca, Celgene and Exactis Innovation, and has research grants from BMS and Iovance. CY is a consultant for Loxo, Merck and Adaptive Biotechnologies, has contracted research with Obi and Pfizer, and has ownership interest in Molpath Dx, LLC. HLK is an employee of Immuneering Coporation.