Reaching beyond maximum grade: progress and future directions for modernising the assessment and reporting of adverse events in haematological malignancies.

Remarkable improvements in outcomes for many haematological malignancies have been driven primarily by a proliferation of novel therapeutics over the past two decades. Targeted agents, immune and cellular therapies, and combination regimens have adverse event profiles distinct from conventional finite cytotoxic chemotherapies. In 2018, a Commission comprising patient advocates, clinicians, clinical investigators, regulators, biostatisticians, and pharmacists representing a broad range of academic and clinical cancer expertise examined issues of adverse event evaluation in the context of both newer and existing therapies for haematological cancers. The Commission proposed immediate actions and long-term solutions in the current processes in adverse event assessment, patient-reported outcomes in haematological malignancies, toxicities in cellular therapies, long-term toxicity and survivorship in haematological malignancies, issues in regulatory approval from an international perspective, and toxicity reporting in haematological malignancies and the real-world setting. In this follow-up report, the Commission describes progress that has been made in these areas since the initial report.

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Declaration of interests CAJ reports personal fees from Kite/Gilead, Novartis, BMS/Celgene, Precision Biosciences, Nkarta, AbbVie, Bluebird Bio, Epizyme, Lonza, and Ipsen, outside the submitted work. DV reports personal fees from AbbVie, AstraZeneca, Kite/Gilead, Kyowa Kirin, Sandoz Canada, Nanostring, Immunovaccine, Roche, Celgene, Seattle Genetics, and Lundbeck/Teva; and research funding (to his institution) from AstraZeneca and Roche, outside the submitted work. GV reports personal fees from Roche, Eisai, Novartis, and Seattle Genetics; and grants from Breast Cancer Now, EORTC, Yorkshire Cancer Research, Pfizer, and IQVIA, outside the submitted work. JaG reports grants from Novartis, Pfizer, Bristol-Myers Squibb, Incyte, Takeda, Servier, UCB, Amgen, Roche, Alnylam, Boehringer-Ingelheim, Biomarin, Daiichi Sankyo, Janssen, Sobi, Gilead, and Bayer, outside the submitted work. JFS reports grants, personal fees, non-financial support, and speakers bureau participation for AbbVie and Roche; personal fees and non-financial support from BMS; personal fees from Genentech, Mei Pharma, Morphosys, Sunesis, and Takeda; and grants and personal fees from Janssen, outside the submitted work. JRW reports personal fees from Merck, Celgene, Cidara, ReViral, Shire, Ansun, Janssen, and Behring, outside the submitted work. KM reports grants from Pfizer, outside the submitted work. LN reports honoraria from ADC Therapeutics, Bayer, and Morphosys; grants and honoraria from BMS/Celgene, Epizyme, Genentech, Gilead/Kite, Novartis, Pfizer, Takeda, and TG Therapeutics; and grants from Caribou Biosciences and IGM Biosciences, outside the submitted work. M-VM reports personal fees from Janssen, BMS-Celgene, Takeda, Amgen, Sanofi, Oncopeptides, Adaptive, GSK, AbbVie, Roche, Seattle Genetics, Pfizer, and Regeneron, outside the submitted work. MH reports grants from U24 CA076518 National Cancer Institute and grants from U24 HL138660 National Heart, Lung and Blood Institute, during the conduct of the study; grants from Amgen, Vor BioPharma, Gamida Cell, Medac, Magenta Therapeutics, Astellas, OncoImmune, and Genentech; and consulting fees from AlloVir, outside the submitted work. MJM reports personal fees from Genentech, Roche, GlaxoSmithKline, Bayer, Pharmacyclics, Janssen, Seattle Genetics, Immunovaccine Technology, and Takeda; consulting advisory roles for Merck, Juno Therapeutics, Teva, and Daiichi Sankyo; research funding from IGM Biosciences; and a consulting advisory role and research funding from Rocket Medical, outside the submitted work. PM reports personal fees from Janssen, Celgene, BMS, AbbVie, Sanofi, and Amgen, outside the submitted work. PS reports research support from Celgene, Amgen, Janssen, and Takeda; and honoraria and serving on advisory boards for Celgene, Janssen, Amgen, Takeda, BMS, and SkylineDx, outside the submitted work. SS reports grants and consulting fees from BMS, Janssen, and Magenta; grants from Allogene; and consulting fees from Oncopeptides, outside the submitted work. TCE-G reports previous employment at Roche and personal fees from AbbVie, outside the submitted work. All other authors declare no competing interests.