Incidence of Treatment-Related Adverse Events From Immune Checkpoint Inhibitors: A Meta-Analysis of Randomized Clinical Trials
Author(s)
Sandeep Bilthare, BTech1, Sandip Ranjan, MTech1, Akshay Phalswal, BTech1, Narotham Reddy Kolli, MPharm1, Kota Vidyasagar, MPharm1, Rizwan Ameen, MPharm1, Ravi Potluri, MBA2.
1Putnam, Gurugram, India, 2Putnam, New York, NY, USA.
1Putnam, Gurugram, India, 2Putnam, New York, NY, USA.
Presentation Documents
OBJECTIVES: Immune checkpoint inhibitors (ICIs) have significantly improved survival outcomes in cancer patients. However, it is of interest to evaluate the incidence of adverse events associated with these therapies. This study aimed to estimate the incidence of grade ≥3 treatment-related adverse events (G3TRAE) and treatment discontinuation due to TRAEs in patients receiving ICIs across various tumor types.
METHODS: A systematic literature review was conducted to identify registrational phase II/III RCTs of ICIs approved by the US FDA for any tumor type. Random-effects meta-analyses were performed to estimate the incidence of G3TRAEs and treatment discontinuation due to TRAEs, stratified by ICI-based regimen and tumor type.
RESULTS: Seventy-two trials involving 51,061 patients treated with ICIs across 14 tumor types were included. The estimated proportion of patients experiencing G3TRAEs and treatment discontinuation due to TRAEs was 16% and 7%, respectively, for anti-programmed cell death-1/programmed cell death ligand-1 (anti-PD-1/PD-L1) monotherapies; 25% and 14% for anti-cytotoxic T-lymphocyte antigen-4 (anti-CTLA-4) monotherapies; 32% and 18% for ICI + ICI combination therapies; 61% and 14% for ICI + chemotherapies; and 70% and 5% for ICI + tyrosine kinase inhibitor (TKI) combinations. The incidence of G3TRAEs varied by tumor type and treatment regimen: in melanoma, it ranged from 13% with anti-PD-1 to 37% with ICI + ICI combinations; in lung cancer, from 15% with anti-PD-1/PD-L1 to 56% with ICI + chemotherapies; in gastrointestinal cancers, from 23% with anti-PD-1 to 62% with ICI + chemotherapies; in bladder cancer, from 7% with anti-PD-1/PD-L1 to 65% with ICI + chemotherapies; and in head and neck cancer, from 15% with anti-PD-1 to 71% with ICI + chemotherapies.
CONCLUSIONS: The incidence of G3TRAEs varied substantially across cancer types and treatment regimens. ICI monotherapies were associated with a lower incidence of G3TRAEs compared to combination regimens involving other ICIs, chemotherapies, or TKIs.
METHODS: A systematic literature review was conducted to identify registrational phase II/III RCTs of ICIs approved by the US FDA for any tumor type. Random-effects meta-analyses were performed to estimate the incidence of G3TRAEs and treatment discontinuation due to TRAEs, stratified by ICI-based regimen and tumor type.
RESULTS: Seventy-two trials involving 51,061 patients treated with ICIs across 14 tumor types were included. The estimated proportion of patients experiencing G3TRAEs and treatment discontinuation due to TRAEs was 16% and 7%, respectively, for anti-programmed cell death-1/programmed cell death ligand-1 (anti-PD-1/PD-L1) monotherapies; 25% and 14% for anti-cytotoxic T-lymphocyte antigen-4 (anti-CTLA-4) monotherapies; 32% and 18% for ICI + ICI combination therapies; 61% and 14% for ICI + chemotherapies; and 70% and 5% for ICI + tyrosine kinase inhibitor (TKI) combinations. The incidence of G3TRAEs varied by tumor type and treatment regimen: in melanoma, it ranged from 13% with anti-PD-1 to 37% with ICI + ICI combinations; in lung cancer, from 15% with anti-PD-1/PD-L1 to 56% with ICI + chemotherapies; in gastrointestinal cancers, from 23% with anti-PD-1 to 62% with ICI + chemotherapies; in bladder cancer, from 7% with anti-PD-1/PD-L1 to 65% with ICI + chemotherapies; and in head and neck cancer, from 15% with anti-PD-1 to 71% with ICI + chemotherapies.
CONCLUSIONS: The incidence of G3TRAEs varied substantially across cancer types and treatment regimens. ICI monotherapies were associated with a lower incidence of G3TRAEs compared to combination regimens involving other ICIs, chemotherapies, or TKIs.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
CO148
Topic
Clinical Outcomes
Topic Subcategory
Clinical Outcomes Assessment
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Oncology