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Practice Guideline
. 2020 Jul;31(7):861-872.
doi: 10.1016/j.annonc.2020.03.299. Epub 2020 Apr 6.

JSCO-ESMO-ASCO-JSMO-TOS: international expert consensus recommendations for tumour-agnostic treatments in patients with solid tumours with microsatellite instability or NTRK fusions

T Yoshino  1 , G Pentheroudakis  2 , S Mishima  3 , M J Overman  4 , K-H Yeh  5 , E Baba  6 , Y Naito  7 , F Calvo  8 , A Saxena  9 , L-T Chen  10 , M Takeda  11 , A Cervantes  12 , H Taniguchi  3 , K Yoshida  13 , Y Kodera  14 , Y Kitagawa  15 , J Tabernero  16 , H Burris  17 , J-Y Douillard  18
Affiliations
Free article
Practice Guideline

JSCO-ESMO-ASCO-JSMO-TOS: international expert consensus recommendations for tumour-agnostic treatments in patients with solid tumours with microsatellite instability or NTRK fusions

T Yoshino et al. Ann Oncol. 2020 Jul.
Free article

Abstract

A Japan Society of Clinical Oncology (JSCO)-hosted expert meeting was held in Japan on 27 October 2019, which comprised experts from the JSCO, the Japanese Society of Medical Oncology (JSMO), the European Society for Medical Oncology (ESMO), the American Society of Clinical Oncology (ASCO), and the Taiwan Oncology Society (TOS). The purpose of the meeting was to focus on what we have learnt from both microsatellite instability (MSI)/deficient mismatch repair (dMMR) biomarkers in predicting the efficacy of anti-programmed death-1 (PD-1)/programmed death ligand-1 (PD-L1) immunotherapy, and the neurotrophic tyrosine receptor kinase (NTRK) gene fusions in predicting the efficacy of inhibitors of the tropomyosin receptor kinase (TRK) proteins across a range of solid tumour types. The recent regulatory approvals of the anti-PD-1 antibody pembrolizumab and the TRK inhibitors larotrectinib and entrectinib, based on specific tumour biomarkers rather than specific tumour type, have heralded a paradigm shift in cancer treatment approaches. The purpose of the meeting was to develop international expert consensus recommendations on the use of such tumour-agnostic treatments in patients with solid tumours. The aim was to generate a reference document for clinical practice, for pharmaceutical companies in the design of clinical trials, for ethics committees in the approval of clinical trial protocols and for regulatory authorities in relation to drug approvals, with a particular emphasis on diagnostic testing and patient selection.

Keywords: NTRK; microsatellite instability; mismatch repair; recommendations; tumour-agnostic.

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Conflict of interest statement

Disclosure EB has received research funding from Taiho, Chugai, Astellas, Merck biopharma, Daiichi Sankyo, Ono, Kyowa-Kirin and Takeda; HB has received fees for consultancy/advisory roles paid to his institution from Mersana, AstraZeneca, FORMA therapeutics, Janssen, Novartis, Roche/Genentech, MedImmune, BMS, Celgene, Incyte, Boehringer Ingelheim, Eisai and Tolero Pharmaceuticals, and research funding paid to his institution from AstraZeneca, Novartis, MedImmune, BMS, Celgene, Incyte, Janssen, Roche/Genentech, MacroGenics, Boehringer Ingelheim, Lilly, Seattle Genetics, Merck, Agios, Jounce Therapeutics, Moderna Therapeutics, CytomX Therapeutics, GlaxoSmithKline, Verastem, Tesaro, Immunocore, Takeda, Millennium, Biomed Valley Discoveries, TG therapeutics, eFFECTOR Therapeutics, Gilead Sciences, BioAtla, CicloMed, Loxo, Vertex, Harpoon Therapeutics, Jiangsu Hengrui Medicine, Arch, Kyocera, Arvinas and Revolution Medicines; AC has received fees for consultancy/advisory roles from Merck Serono, Roche, BeiGene, Bayer, Servier, Eli Lilly, Novartis, Takeda, Astellas and Pierre Fabre and research funding from Genentech, Merck Serono, Roche, BeiGene, Bayer, Servier, Eli Lilly, Novartis, Takeda, Astellas, FibroGen, Amcure, Sierra Oncology, AstraZeneca, Medimmune, BMS and MSD; FC has received fees for consultancy/advisory roles from Phillips; L-TC has received research funding from Novartis, Merck Serono, TTY, Polaris, SyncorePharm, Pfizer, and BMS, honoraria from ONO, Eli Lilly, MSD, Pharma Engine, TTY, SyncorePharm, Novartis, AstraZeneca and Ipsen, patents and royalties for ENO-1 mAb from HuniLife, and is a Scientific Advisory Board member at Pharma Engine and a board member at Sinopharm Taiwan, Ltd; YK has received fees for consultancy/advisory roles from Ono Asahi Kasei and BMS research funding from Taiho, Chugai, Yakult, Daiichi-Sankyo, Merck Serono, Asahi Kasei, EA Pharma, Otsuka Pharmaceutical Co., Ltd, Otsuka Pharmaceutical Factory Inc., Takeda, Shionogi, Kaken Pharmaceuticals, Kowa Pharmaceuticals, Astellas, Medicon, Dainippon Sumitomo Pharmaceuticals, Taisho Toyama Pharmaceuticals, Kyowa Kirin, Pfizer Japan, Ono, NIHON, Japan Blood Products Organization, Medtronic Japan, Sanofi K.K., and grants from Eisai, Tsumura, KCI Licensing, Inc, Abbott Japan, Fuji Film and Toyama Chemical Co.; YKo has receive research funding from Taiho, Chugai, Takeda, MSD, Nihon Kayaku, Yakult, Lilly Japan, Ono, EA Pharma, Novartis, Daiichi-Sankyo, BMS and Sanofi; YN has received fees for consultancy/advisory roles from Eli Lilly, AstraZeneca, Chugai, Pfizer, Novartis, Eisai, Bayer, Fuji Film Toyama Chemistry, Shionogi, Taiho, Ono, Guardent Health, Kyowa Kirin and Mundipharma; MJO has received fees for consultancy/advisory roles from Janssen Research and Development LLC, AgilVax, Takeda Pharmaceuticals (Japan), Acrotech Biopharma, Promega, Genentech Inc., and Novartis Pharmaceuticals and research funding from Roche, BMS, Merck, AstraZeneca and Nouscom; GP has received fees for consultancy/advisory roles from Roche, Merck and Amgen and research funding from: Roche, Amgen, Novartis, MSD, BMS, Pfizer, Boehringer and Astra Zeneca; AS has received fees for consultancy from Genentech, AstraZeneca and Medtronic and for advisory boards from AstraZeneca and Takeda; JT has received fees for consultancy/advisory roles from Array Biopharma, AstraZeneca, Bayer, BeiGene, Boehringer Ingelheim, Chugai, Genentech, Genmab A/S, Halozyme, Imugene Limited, Inflection Biosciences Limited, Ipsen, Kura Oncology, Eli Lilly, MSD, Menarini, Merck Serono, Merrimack, Merus, Molecular Partners, Novartis, Peptomyc, Pfizer, Pharmacyclics, ProteoDesign SL, Rafael Pharmaceuticals, F. Hoffmann-La Roche Ltd, Sanofi, SeaGen, Seattle Genetics, Servier, Symphogen, Taiho, VCN Biosciences, Biocartis, Foundation Medicine, HalioDx SAS and Roche Diagnostics; MT has received fees for consultancy/advisory roles from Chugai; HT has received research funding from Sysmex, Takeda and Daiichi-Sankyo; KHY has received fees for consultancy/advisory roles from Amgen, Boehringer Ingelheim, Bayer, BMS, MSD, Merck Serono, Eli Lilly, Ono and Takeda; KY has received fees for consultancy/advisory roles from Abbott, AbbVie, Asa hi Kasei Pharma, Astellas, Biogen Japan, Celgene, Chugai, Covidien Japan, Daiichi Sankyo, Eisai, Eli Lilly Japan, GlaxoSmithKline, Johnson & Johnson, KCI, Kyowa Kirin, Meiji Seika Pharma, Merck Serono, MSD, Nippon Kayaku, Novartis, Ono Pharm., Otsuka Pharm., Sanofi, Taiho Pharm., Toray Medical, Tsumura and Yakult Honsha; TY has received research funding from Novartis Pharma K.K., MSD K.K., Sumitomo Dainippon Pharma Co., Ltd, Chugai, Sanofi K.K., Daiichi Sankyo, Parexel International Inc., Ono, GlaxoSmithKline K.K. and Boehringer Ingelheim Japan. JYD and SM declare no conflicts of interests.

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