Evaluating the Validity of Immunotherapy in Retreatment and Rechallenge Strategies for Oncology Patients
Author(s)
Ilona Czarny-Ozga, MPH1, Kamila Wojas-Krawczyk, Professor, MD, PhD, DSc2, Jakub Zolnierek, MD, PhD3, Izabela Pieniazek, MSc1.
1Certara, Cracow, Poland, 2Pneumonology, Oncology and Allergology Department, Medical Univeristy of Lublin, Lublin, Poland, 3Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.
1Certara, Cracow, Poland, 2Pneumonology, Oncology and Allergology Department, Medical Univeristy of Lublin, Lublin, Poland, 3Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.
OBJECTIVES: Immunotherapy is nowadays standard in treating malignant tumors. While immunotherapy moves to early stages of medical pathway (neoadjuvant, adjuvant, first-line), patients in advanced stages often lack effective options. Given this unmet need, the potential of retreatment (ReT) or rechallenge (ReC) with immune checkpoint inhibitors (ICIs) is under discussion.The aim was to identify and evaluate key clinical data justifying the validity of ReT/ReC in oncology, focusing on melanoma, non-small cell lung cancer (NSCLC), and renal cell carcinoma (RCC).
METHODS: A targeted literature review (TLR) was conducted in PubMed on September 9, 2024, identifying clinical data addressing ICI reinitiation.
RESULTS: ReT/ReC with ICIs has a strong theoretical, molecular, and clinical rationale. Guidelines now include recommendations for ICI reuse, focusing on patient subgroups most likely to benefit. A 6-month interval after the last ICI dose is considered a potential window for reinitiation. The TLR included four systematic reviews, two secondary studies, and 41 primary studies, including 10 randomized controlled trials. The growing number of publications and study findings support the clinical relevance of ICI reuse. Evidence suggests ReT/ReC may be beneficial not only in metastatic settings but also in earlier treatment stages. However, efficacy tends to be lower, and adverse events (AEs) may be more frequent than during initial therapy. Thus, decisions to reintroduce ICIs should be individualized, balancing potential benefits against immune-related AEs and considering the patient’s overall condition and treatment history.
CONCLUSIONS: ReT/ReC with immunotherapy is a promising strategy for extending clinical benefit in cancer care. It is increasingly recognized as a viable component of real-world therapeutic approaches.
METHODS: A targeted literature review (TLR) was conducted in PubMed on September 9, 2024, identifying clinical data addressing ICI reinitiation.
RESULTS: ReT/ReC with ICIs has a strong theoretical, molecular, and clinical rationale. Guidelines now include recommendations for ICI reuse, focusing on patient subgroups most likely to benefit. A 6-month interval after the last ICI dose is considered a potential window for reinitiation. The TLR included four systematic reviews, two secondary studies, and 41 primary studies, including 10 randomized controlled trials. The growing number of publications and study findings support the clinical relevance of ICI reuse. Evidence suggests ReT/ReC may be beneficial not only in metastatic settings but also in earlier treatment stages. However, efficacy tends to be lower, and adverse events (AEs) may be more frequent than during initial therapy. Thus, decisions to reintroduce ICIs should be individualized, balancing potential benefits against immune-related AEs and considering the patient’s overall condition and treatment history.
CONCLUSIONS: ReT/ReC with immunotherapy is a promising strategy for extending clinical benefit in cancer care. It is increasingly recognized as a viable component of real-world therapeutic approaches.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HSD47
Topic
Clinical Outcomes, Health Policy & Regulatory, Health Service Delivery & Process of Care
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Oncology