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e-Poster Display Session

35P - Toxicity and safety of novel immuno-oncology (IO) treatments after prior immune checkpoint inhibitors (ICIs) exposure


09 Dec 2020


e-Poster Display Session


Augusto Valdivia


Annals of Oncology (2020) 31 (suppl_7): S1428-S1440. 10.1016/annonc/annonc391


A. Valdivia1, A. Hernando2, O. Saavedra2, R. Berché2, I. Braña2

Author affiliations

  • 1 Vall d'Hebron University Hospital, Barcelona/ES
  • 2 Vall d'Hebron Institute of Oncology (VHIO)-Cellex Center, Barcelona/ES

Abstract 35P


Despite positive effects of ICIs in multiple tumor types, lack of harmonized biomarkers for immune related adverse events (irAEs) remains a challenge. Patients (pts) with prior moderate or severe irAEs are excluded from early IO trials. We investigated whether irAEs during prior ICIs impacts on the risk of developing additional irAEs for subsequent IO lines.


Pts treated with IO within phase I clinical trials (IO-Phase1) from 2016-2020 were reviewed. Among 568, 101 pts with prior ICIs exposure (IO-prePhase1) were selected. The incidence, type, duration and severity of irAEs were collected for IO-prePhase1 and IO-Phase1. The severity of irAEs was classified as per CTCAE v.4.03.


Out of 101 pts, median age was 58.5 years, all ECOG ≤1. Up to 30 pts experienced irAEs of any grade, 16 (15.8%) during IO-prePhase1 and 14 (13.7%) during IO-Phase1. The most frequent irAEs were thyroiditis 31%, colitis 19% and rash 19% during IO-prePhase1 vs colitis 21%, hepatitis 14% and hypophysitis 14% during IO-Phase1. Five out of 16 pts that experienced irAEs during IO-prePhase1 developed a new irAE during IO-Phase1. The OR for suffering a new irAE after prior irAE was 3.8 (p=0,03, Chi2). No significant association was observed in type or severity of irAEs between IO-prePhase1 and IO-Phase1. Up to 38% of pts experiencing irAEs during IO-prePhase1 required corticosteroids (CT) versus 50% in IO-Phase1. The median time to onset of irAEs was 43 days (23-161) for IO-prePhase1 vs 68 days (33-126) for IO-Phase1 (p=0.23 Wilcoxon). No significant differences were found in irAEs duration: 201 days (22-573) in IO-prePhase1 vs 58.5 (18-102) in IO-Phase1 (p=0.23, Wilcoxon). Importantly, 4 pts discontinued treatment during IO-PrePhase1 due to an irAE. Only 1 pt out of 4 experienced a new irAE during IO-Phase1 successfully managed with CT treatment. Interestingly, incidence irAEs as a time-dependent variable for IO-Phase1 was not significantly associated with overall survival (p= 0.9 logrank).


Our results suggest that experiencing irAEs during prior ICIs may increase the probability of suffering new irAEs for subsequent IO lines. The consideration of novel IO treatments for this subset of patients should be individualized.

Legal entity responsible for the study

The authors.


Has not received any funding.


A. Hernando: Travel/Accommodation/Expenses: Bristol Myers-Squibb; Travel/Accommodation/Expenses: Kyowa Kirin; Travel/Accommodation/Expenses: Merck; Research grant/Funding (self): TTCC; Research grant/Funding (self): Hold´em for life. I. Braña: Advisory/Consultancy: Orion Pharma; Advisory/Consultancy: MSD; Advisory/Consultancy: Rakuten Aspyrian; Speaker Bureau/Expert testimony: BMS; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: AstraZeneca; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Merck Serono. M. Vieito Villar: Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy: Debiopharm; Advisory/Consultancy: TFS; Travel/Accommodation/Expenses: EMD Seton. L. Fariñas Madrid: Advisory/Consultancy: Tesaro; Advisory/Consultancy: GSK; Speaker Bureau/Expert testimony: AstraZeneca; Speaker Bureau/Expert testimony: Roche; Speaker Bureau/Expert testimony: MSD. P. Iranzo Gomez: Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol Myers Squibb; Honoraria (self), Advisory/Consultancy: F. Hoffmann La Roche AG; Advisory/Consultancy, Travel/Accommodation/Expenses: Merck Sharp & Dohme; Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Travel/Accommodation/Expenses: Boehringer Ingelheim; Advisory/Consultancy: MSD Oncology; Advisory/Consultancy: Rovi; Advisory/Consultancy: Grunenthal Pharma S.A.. E. Muñoz Couselo: Honoraria (self), Advisory/Consultancy: Bristol Myers Squibb; Honoraria (self), Advisory/Consultancy: Amgen; Honoraria (self), Advisory/Consultancy: Merck Sharp & Dohme; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Pierre Fabre; Honoraria (self), Advisory/Consultancy: Roche; Advisory/Consultancy: Sanofi. J. Tabernero: Advisory/Consultancy: Array Biopharma; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Bayer; Advisory/Consultancy: BeiGene; Advisory/Consultancy: Boehringer Ingelheim; Advisory/Consultancy: Chugai; Advisory/Consultancy: Genentech, Inc.; Advisory/Consultancy: Genmab A/S; Advisory/Consultancy: Halozyme; Advisory/Consultancy: Imugene Limited; Advisory/Consultancy: Inflection Biosciences Limited; Advisory/Consultancy: Ipsen; Advisory/Consultancy: Kura Oncology; Advisory/Consultancy: Lilly; Advisory/Consultancy: MSD; Advisory/Consultancy: Menarini; Advisory/Consultancy: Merck Serono; Advisory/Consultancy: Merrimack; Advisory/Consultancy: Merus; Advisory/Consultancy: Molecular Partners. R. Dienstmann: Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Research grant/Funding (institution): Merck; Speaker Bureau/Expert testimony: Ipsen; Speaker Bureau/Expert testimony: Sanofi; Speaker Bureau/Expert testimony: MSD Oncology; Speaker Bureau/Expert testimony: Servier; Speaker Bureau/Expert testimony: Amgen. E. Garralda: Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Advisory/Consultancy: Ellipses Pharma; Advisory/Consultancy: Neomed Therapeutics; Advisory/Consultancy: Janssen; Advisory/Consultancy: Boehringer Ingelheim; Advisory/Consultancy: Seattle Genetics; Advisory/Consultancy: TFS; Advisory/Consultancy: Alkermes; Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony: Thermo Fisher Scientific; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Bristol Myers Squibb; Speaker Bureau/Expert testimony: MSD; Honoraria (institution): Novartis; Travel/Accommodation/Expenses: Menarini; Travel/Accommodation/Expenses: Glycotope; Travel/Accommodation/Expenses: Merck Sharp & Dohme. All other authors have declared no conflicts of interest.

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