Abstract 1071P
Background
The utilization of immune checkpoint inhibitors (ICIs) has become increasingly prevalent in cancer treatment. However, ICIs may also precipitate a spectrum of immune-related adverse events, which can target various organ systems. Among these, pulmonary immune-related adverse events (pirAEs) are the leading cause of ICI cessation and mortality.
Methods
Individual Case Safety Reports (ICSRs) were obtained from FAERS and VigiBase. We identified reports pertaining to eight ICIs for the purposes of this study, namely nivolumab, pembrolizumab, cemiplimab, atezolizumab, avelumab, durvalumab, ipilimumab, and tremelimumab. Subsequently, we utilized expert consensus to select 52 significant pirAEs with high incidence or of clinical significance and then evaluated the incidence and mortality of pirAEs across varying time periods following the initiation of ICIs therapy.
Results
16,372 and 7,943 ICSRs were collected using FAERS and VigiBase, respectively. More than 50% of pirAEs occurred within 60 days after treatment with ICIs (FAERS:70.0%,VigiBase:55.7%), and their mortality was higher than that after 60 days (15% vs 12%, 12% vs 7%). In each period after the use of ICIs, pirAEs with the highest incidence were interstitial lung disease (14.6%,26.4%), dyspnoea (18.4%,17.0%)and pneumonitis (13.0%,17.0%). The all-cause mortality of respiratory failure (30%, 58%), pulmonary hemorrhage (28%,57%), acute interstitial pneumonitis (75%, 27%), and stridor (31%, 30%)was over 25%. The mortality of respiratory failure remained stable at a high level in each period after initiation of immune therapy (24-40%, 42-69%).
Conclusions
Using data from the FAERS and VigiBase, we conducted an analysis of the frequency and incidence of pirAEs during varied periods after the onset of ICIs therapy. We offer a groundbreaking revelation, identifying the occurrence of pirAEs which manifest early on, within the initial 60 days of treatment, and exhibit a high incidence and mortality rate. Among pirAEs, interstitial lung disease, dyspnea, and pneumonitis were most frequently reported with respiratory failure being a consistently fatal adverse event highlighting the necessity of heightened physician vigilance.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
1047P - AXA-042, a systemically administered TLR2/6 agonist, demonstrates target engagement and TLR pathway activation in patients with advanced solid tumors
Presenter: Ben Tran
Session: Poster session 19
1048P - Phase I/II Study of JK08, an IL-15 antibody fusion protein targeting CTLA-4, with unresectable locally advanced or metastatic cancer
Presenter: Nuria Kotecki
Session: Poster session 19
1049P - Phase Ib/II trial of envafolimab, a novel subcutaneous single-domain anti-PD-L1 monoclonal antibody, plus lenvatinib in patients with selected advanced solid tumors
Presenter: Tianshu Liu
Session: Poster session 19
1050P - Sensitization to immunotherapy through manipulation of tumor transcription by lurbinectedin
Presenter: Joan Russo-Cabrera
Session: Poster session 19
1051P - Intratumoral injection of LTX-315 in combination with pembrolizumab in patients with advanced melanoma refractory to prior PD-1/PD-L1 therapy: Interim results from the ATLAS-IT-05 trial
Presenter: Stephane Dalle
Session: Poster session 19
1052P - Phase-Ib trial of metformin combined with nivolumab for refractory/recurrent solid tumors
Presenter: Toshio Kubo
Session: Poster session 19
1053P - Tumor-restricted delivery of an immune-therapeutic payload by modified macrophages for the treatment of glioblastoma: The TEM-GBM STUDY (NCT03866109)
Presenter: Fabio Ciceri
Session: Poster session 19
1054P - A phase Ia study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of a modular CLDN18.2-targeting PG CAR-T therapy (IBI345) in patients with CLDN18.2+ solid tumors
Presenter: Songbing Qin
Session: Poster session 19
1055P - Safety and Activity of SmarT cells plus PD-1 blocking antibodies in patients with heavily pretreated solid cancers: An open-label and dose-escalation study
Presenter: Qin Liu
Session: Poster session 19
1056P - Efficacy of spartalizumab across multiple cancer types in patients with PD1-high mRNA expressing tumors (SOLTI-1904 ACROPOLI)
Presenter: Aleix Prat
Session: Poster session 19