ArticleClinical and translational science2022
Evaluation of atezolizumab immunogenicity: Clinical pharmacology (part 1).
Article in Clinical and translational science, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 3 of them syntheses that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
35 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Treatment-emergent antidrug antibodies related to PD-1, PD-L1, or CTLA-4 inhibitors across tumor types: a systematic review.Journal for immunotherapy of cancer · 2024Pooled it
- Pre-treatment soluble PD-L1 as a predictor of overall survival for immune checkpoint inhibitor therapy: a systematic review and meta-analysis.Cancer immunology, immunotherapy : CII · 2023Pooled it
- Allelic variation in HLA-DRB1 is associated with development of antidrug antibodies in cancer patients treated with atezolizumab that are neutralizing in vitro.Clinical and translational science · 2022Pooled it
- Ligelizumab Immunogenicity and Impact on Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety in Patients With Chronic Spontaneous Urticaria.Clinical and translational science · 2026Trial
- LOAd703-induced tumor microenvironment gene engineering in combination with atezolizumab in metastatic malignant melanoma: a phase I/II trial.Nature communications · 2026Trial
- Population Pharmacokinetics and Exposure-Response of Subcutaneous Atezolizumab in Patients With Non-Small Cell Lung Cancer.CPT: pharmacometrics & systems pharmacology · 2025Trial
- Atezolizumab Plus PEGPH20 Versus Chemotherapy in Advanced Pancreatic Ductal Adenocarcinoma and Gastric Cancer: MORPHEUS Phase Ib/II Umbrella Randomized Study Platform.The oncologist · 2023Trial
- Advancing Systemic Treatment beyond First Line for Advanced Hepatocellular Carcinoma.Current oncology reports · 2026Review
- Review
- Revisiting the Anti-Drug Antibody Assay Drug Tolerance of a Commercial Biological Product.The AAPS journal · 2025Article
- Assessment of Neutralizing Antibody Activity in Clinical Studies: Use of Surrogate Measurements Instead of Stand-alone Assays.The AAPS journal · 2025Review
- Structure-activity relationship ofEJNMMI radiopharmacy and chemistry · 2025Article
- A Model-Based Approach to Evaluate Anti-Drug Antibody Impact on Drug Exposure With Biologics: A Case Example With the CD3 T-Cell Bispecific Cibisatamab.CPT: pharmacometrics & systems pharmacology · 2025Article
- IQ Survey Results on Current Industry Practices: Part 2-Quantitative Evaluations of Immunogenicity Assessment.Clinical pharmacology and therapeutics · 2025Review
- Second-line treatment patterns and outcomes in advanced HCC after progression on atezolizumab/bevacizumab.JHEP reports : innovation in hepatology · 2025Article
- Evaluating the Immunogenicity Risk of Protein Therapeutics by Augmenting T Cell Epitope Prediction with Clinical Factors.The AAPS journal · 2025Article
- High level of anti-drug antibodies is associated with shorter survival in advanced solid cancer patients treated with Immune checkpoint inhibitors.Immunotherapy advances · 2025Article
- Immunogenicity dynamics and covariate effects after satralizumab administration predicted with a hidden Markov model.CPT: pharmacometrics & systems pharmacology · 2024Article
- An Evidence-Based Rationale for Dose De-escalation of Subcutaneous Atezolizumab.Targeted oncology · 2024Article
- Immunogenicity of Atezolizumab: Influence of Testing Method and Sampling Frequency on Reported Anti-drug Antibody Incidence Rates.The AAPS journal · 2024Article
Corrections and comments
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Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Baseline patient characteristics and prognostic factors are important considerations in oncology when evaluating the impact of immunogenicity on pharmacokinetics (PK) and efficacy. Here, we assessed the impact of anti-drug antibodies (ADA) on the PK of the immune checkpoint inhibitor atezolizumab (an anti-PD-L1 monoclonal antibody). We evaluated data from ≈ 4500 patients from 12 clinical trials across different tumor types, treatment settings, and dosing regimens. In our dataset, ~ 30% of patients (range, 13-54%) developed treatment-emergent ADA, and in vitro neutralizing antibodies (NAb) were seen in ~ 50% of ADA-positive (+) patients. Pooled time course data showed a trend toward lower atezolizumab exposure in ADA+ patients, which was more pronounced in ADA+/NAb+ patients. However, the atezolizumab concentration distributions overlapped, and drug concentrations exceeded 6 µg/ml, the target concentration required for receptor saturation, in greater than 95% of patients. Patients had sufficient exposure regardless of ADA status. The dose selected to allow for dosing over effects from ADA resulted in a flat exposure-response relationship. Analysis of study results by ADA titer showed that exposure and overall survival were not affected in a clinically meaningful way. High tumor burden, low albumin, and high CRP at baseline showed the greatest association with ADA development but not with subsequent NAb development. These imbalanced factors at baseline can confound analysis of ADA impact. ADA increases atezolizumab clearance minimally (9%), and its impact on exposure based on the totality of the clinical pharmacology assessment does not appear to be clinically meaningful.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.