Bavencio (avelumab) / EMD Serono - LARVOL DELTA

Hematologic adverse events associated with immune checkpoint inhibitors: A real-world pharmacovigilance analysis using the faers database (ASH 2025) - "We employed 8 ICIs (including the brand and generic names)—atezolizumab, avelumab, cemiplimab, durvalumab, ipilimumab, nivolumab, pembrolizumab, and tremelimumab in the analysis. This large, real-world pharmacovigilance study provides comprehensive insight into hematologic adverse events associated with ICIs. Immune thrombocytopenia was the most prominent signal across agents, with additional drug-specific patterns observed. These findings underscore the need for focused monitoring strategies and may inform clinical decision-making and future prospective safety evaluations."

Adverse events • Checkpoint inhibition • Clinical • Real-world • Real-world evidence • Acute Myelogenous Leukemia • Aplastic Anemia • Autoimmune Hemolytic Anemia • Febrile Neutropenia • Hematological Malignancies • Immune Thrombocytopenic Purpura • Immunology • Leukemia • Lymphoma • Myelodysplastic Syndrome • Neutropenia • Oncology • Thrombocytopenia • Thrombocytopenic Purpura • ROR1

Early versus late onset hematologic immune‐related adverse events following immune checkpoint inhibition: Temporal patterns, clinical profiles, and risk stratification in faers reports (2014–2025) (ASH 2025) - "Agent-level analysis showed significantly reduced fatality odds with pembrolizumab (OR 0.44; 95% CI 0.42–0.46), atezolizumab (OR 0.54; 95% CI 0.52–0.56), avelumab (OR 0.54; 95% CI 0.49–0.59), durvalumab (OR 0.53; 95% CI 0.46–0.60), and ipilimumab (OR 0.84; 95% CI 0.79–0.88) versus nivolumab. Early and late hem-irAEs represent distinct clinical entities. Early events, driven by cytopenias, may reflect acute immune activation, while late events involve marrow failure with greater morbidity. Despite marginally lower fatality, late hem-irAEs were more often serious."

Adverse events • Checkpoint inhibition • Clinical • IO biomarker • Aplastic Anemia • Hematological Disorders • Hemophagocytic lymphohistiocytosis • Immunology • Neutropenia • Oncology • Rare Diseases • Thrombocytopenia

Expression of the cancer testis antigen PRAME is associated with response to immune checkpoint inhibitor and rituximab priming in treatment-naïve diffuse large B-cell lymphoma (ASH 2025) - "Though immunecheckpoint inhibitors (ICI) have limited efficacy in unselected, heavily pre-treated DLBCL (Ansell JCO2019), responses have been reported in select subgroups, e.g. primary mediastinal B-cell lymphoma andEBV-positive DLBCL (Armand Blood 2018, Nayak Blood 2017).In our phase II AvR-CHOP study, treatment-naïve DLBCL patients (pts) received priming with avelumab(anti-PD-L1) and rituximab (AvRp) prior to R-CHOP. Thesefindings identify PRAME as a potential predictive biomarker in ICI-treated DLBCL and build on priorreports of PRAME-specific T-cell efficacy in lymphoma. Further study is warranted to elucidate therelationship between PRAME expression, tumour immunobiology and response to T cell–directedtherapies in DLBCL."

Checkpoint inhibition • IO biomarker • Tumor mutational burden • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Mediastinal B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma • CT45A1 • MAGEA3 • PRAME • TMB

CPC04 Avelumab-induced sarcoidosis during therapy for metastatic Merkel cell carcinoma. (PubMed, Br J Dermatol) - "Case Rep Oncol 2019; 12: 621-7). Given the ever-increasing role of immunotherapy to treat advanced skin cancers, clinicians need to be aware of these complications as the incidence is likely to increase."

Journal • Genetic Disorders • Glomerulonephritis • Immunology • Lupus Nephritis • Melanoma • Merkel Cell Carcinoma • Nephrology • Non-melanoma Skin Cancer • Oncology • Sarcoidosis • Skin Cancer • Solid Tumor

SELECTIO-UC STUDY: Prospective evaluation of the DDR genes alteration to predict response to platinum-based chemotherapy in advanced urothelial cancer (ESMO Asia 2025) - "Eligible pts will receive cisplatin/carboplatin (AUC5 or AUC4) + gemcitabine for 4-6 cycles, followed by maintenance avelumab in case of disease control, as per clinical practice. The primary endpoint is to assess the difference in Overall Response Rate (ORR) between pts with or without DDR genes alterations. Secondary/exploratory endpoints include: PFS, OS, Disease Control Rate (DCR), incidence of adverse events, incidence of DDR alterations and of expression of Nectin4, PDL1, Trop2 and Her2 proteins."

Clinical • IO biomarker • Metastases • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • ATRX • BRCA1 • BRCA2 • BRIP1 • ERCC1 • ERCC2 • ERCC3 • ERCC4 • ERCC5 • FANCA • FANCC • FANCD2 • FANCF • FANCG • HER-2 • MLH1 • MSH2 • NECTIN4 • PALB2 • PD-L1 • PMS1 • PMS2 • PRKDC • RB1 • WRN

JAVEMACS chart review study of avelumab maintenance therapy for advanced urothelial carcinoma (aUC) in Japan: Subgroup analyses based on eligibility for cisplatin or platinum-based chemotherapy (PBC) (ESMO Asia 2025) - "Of pts who discontinued avelumab in the CE, CI/PE, and PI subgroups, second- line therapy was received by 60/84 (71%), 106/150 (71%), and 15/24 (63%), including enfortumab vedotin in 36/60 (60%), 72/106 (68%), and 12/15 (80%), respectively. Data from the real-world JAVEMACS study show the effectiveness of avelumab maintenance in pts with aUC not progressed after 1L PBC, including pts considered ineligible for cisplatin or PBC per standard criteria."

Clinical • Metastases • Review • Oncology • Solid Tumor • Urothelial Cancer

JAVEMACS chart review study of avelumab maintenance therapy for advanced urothelial carcinoma (aUC) in Japan: Subgroup analyses based on histological subtype (ESMO Asia 2025) - "Of pts who discontinued avelumab in the pure UC and variant subgroups, second-line therapy was received by 155/226 (69%) and 30/38 (79%), including enfortumab vedotin in 99/155 (64%) and 21/30 (70%), respectively. Real-world data from Japan show the effectiveness of avelumab maintenance in pts with aUC not progressed after 1L PBC, including pts with pure UC or histological subtypes."

Clinical • Metastases • Review • Oncology • Solid Tumor • Urothelial Cancer

JAVEMACS chart review study of avelumab maintenance for advanced urothelial carcinoma (aUC): Analyses by primary tumour location (ESMO Asia 2025) - "In the UTUC and BC subgroups, respectively, creatinine clearance ≥60 mL/min was 20% and 42%, while 50% and 62% of patients received gemcitabine + cisplatin, 41% and 26% received gemcitabine + carboplatin as 1L PBC. Among those who discontinued avelumab, 75% (100/133) of UTUC and 67% (98/147) of BC patients received second-line therapy, with 72% (72/100) and 60% (59/98) receiving enfortumab vedotin (EV), respectively... The subgroup analysis of the JAVEMACS study revealed that in patients treated with avelumab 1L maintenance therapy, similar improvements in survival outcomes were observed in both UTUC and BC subgroups. Additionally, in the Japanese real world, EV was frequently used as 2L therapy, regardless of primary tumor location. These results help inform clinical decision-making for optimal patient management, as prognosis may vary by tumour location."

Clinical • Metastases • Review • Bladder Cancer • Oncology • Solid Tumor • Urothelial Cancer

Immune-related adverse events associated with immune checkpoint inhibitor therapy in bladder cancer patients: A systematic review and meta-analysis. (PubMed, Urol Oncol) - "Phase II or III randomized controlled trials (RCTs) where one of the experimental arms consisted of atezolizumab, pembrolizumab, nivolumab, or avelumab monotherapy were included. Bladder cancer patients treated with ICIs are at significant risk of irAEs. These events vary in severity, and appropriate management of these adverse events should be prioritized to improve quality of life."

Adverse events • Checkpoint inhibition • Journal • Retrospective data • Review • Bladder Cancer • Dermatology • Endocrine Disorders • Gastroenterology • Gastrointestinal Disorder • Genito-urinary Cancer • Immunology • Nephrology • Oncology • Pneumonia • Pruritus • Solid Tumor

A New Direction in Endometrial Cancer Therapy-PD-1 and PD-L1 Immune Checkpoint Inhibitors-Where Will It Take Us? (PubMed, J Clin Med) - "Other inhibitors such as atezolizumab, dostarlimab, durvalumab, nivolumab and avelumab also demonstrate high clinical efficacy, as they prolong median PFS compared to the control group, but more studies are needed in much larger study groups to assess their safety and efficacy in different age groups. Future studies should focus on the efficacy of ICIs in younger groups of patients with EC, as well as on drugs from this group that are used less frequently in clinical trials than pembrolizumab, which would allow for a thorough comparison of the efficacy of drugs with each other and the selection of the drug individually to the patient's needs."

Checkpoint inhibition • Journal • Review • Endometrial Cancer • Oncology • Solid Tumor

Dynamic PD-L1 Regulation Shapes Tumor Immune Escape and Response to Immunotherapy. (PubMed, Cancers (Basel)) - "To investigate this, we adapted an ordinary differential equation model of combination therapy, incorporating the dynamics of the immune checkpoint inhibitor Avelumab and the immunostimulant NHS-muIL12. This work provides a validated mechanistic framework for adaptive resistance in combination immunotherapy. Quantified parameter differences between responder and non-responder phenotypes enable clearer biological interpretation and support the development of predictive tools for optimizing treatment strategies."

IO biomarker • Journal • Oncology

Combination immunotherapy in Japanese patients with advanced renal cell carcinoma: bridging gaps between clinical trials, real-world evidence, and the potential value of adverse events-a narrative review. (PubMed, Transl Cancer Res) - "Nivolumab plus ipilimumab (NIVO + IPI) and various ICI + TKI regimens (avelumab + axitinib, pembrolizumab + axitinib, nivolumab + cabozantinib, pembrolizumab + lenvatinib) have shown superior efficacy to sunitinib in pivotal trials...TRAEs show promise as prognostic markers in NIVO + IPI but require further validation in ICI + TKI. Prospective multicenter registries with standardized adverse event reporting, coupled with translational studies, are needed to refine regimen selection and personalized therapy."

Adverse events • HEOR • IO biomarker • Journal • Real-world evidence • Review • Genito-urinary Cancer • Kidney Cancer • Non Clear Cell Renal Cell Carcinoma • Oncology • Renal Cell Carcinoma • Solid Tumor

Immunotherapy-Related Hematological Adverse Events: Incidence and Outcomes (ASH 2023) - "We identified all adults (≥ 18 years) with a diagnosis of neoplasm (ICD-10: C00-D49), and documented use of IO including pembrolizumab, nivolumab, atezolizumab, avelumab, durvalumab and ipilimumab, between 2015-2023...Additionally, patients with ITP were treated with IVIG (15.4%), Romiplostim (11.1%), Rituximab (9.1%), and Eltrombopag (8.3%), less commonly with MMF and cyclosporine... In this large national cohort, the real world incidence of heme irAEs was low. However, despite its rarity, development of heme irAEs was associated with increased mortality in individuals with cancer who received IO. Early recognition and prompt intervention are crucial to optimize its management."

Adverse events • Anemia • Autoimmune Hemolytic Anemia • Hematological Disorders • Immune Thrombocytopenic Purpura • Immunology • Oncology • Solid Tumor • Thrombocytopenia • Thrombocytopenic Purpura

Immunotherapy-Associated Immune Thrombocytopenia: Treatment Paradigms (ASH 2023) - "We categorized patients into two cohorts: IO-ITP, those with a diagnosis of ITP after IO use (pembrolizumab, nivolumab, atezolizumab, avelumab, durvalumab, ipilimumab) and a diagnosis of neoplasm (ICD-10: C00-D49); and p-ITP: those with ITP without neoplasm nor IO use...We investigated the use of first-line and rescue therapies: glucocorticoids and IVIG; second-line therapies: thrombopoietin agonists (TPO-RAs: romiplostim and eltrombopag) and rituximab; third-line therapies: cyclophosphamide, azathioprine, cyclosporine, mycophenolate mofetil, bortezomib, avatrombopag and fostamatinib; and splenectomy, based on guidelines for management of p-ITP... Our study describes treatment patterns in IO-ITP, an uncommon but challenging disease. We found that individuals with IO-ITP are generally younger and predominantly male as compared to p-ITP, highlighting different patient profiles. We further demonstrated some distinctions in the management of these two conditions, possibly..."

Hematological Disorders • Immune Thrombocytopenic Purpura • Oncology • Skin Cancer • Thrombocytopenia • Thrombocytopenic Purpura

From Survival to Side Effects: Retrospective Analysis of Adverse Events in Checkpoint Inhibitor Therapy for Melanoma Using the FAERS Database (EADV 2025) - "Reports were included if the indication was malignant or metastatic melanoma and the treatment involved checkpoint inhibitors (Nivolumab, Pembrolizumab, Cemiplimab, Atezolizumab, Avelumab, Durvalumab, Ipilimumab, Tremelimumab, or Relatlimab). This study provides the most comprehensive FAERS-based analysis to date of checkpoint inhibitor- associated adverse events in melanoma treatment. While PD-1 inhibitors dominate current usage, significant differences in AE profiles, fatality rates, and geographic patterns exist across drug classes. These findings can guide clinicians in personalized risk assessment and AE monitoring strategies for patients undergoing immunotherapy."

Adverse events • Checkpoint inhibition • Retrospective data • Cardiovascular • Melanoma • Oncology • Solid Tumor • LAG3

Immune checkpoint inhibitors for recurrent ovarian clear cell carcinoma: Real-world outcomes from a Korean multicenter study. (PubMed, Gynecol Oncol) - "Although ICIs were well tolerated, their antitumor activity in recurrent OCCC was limited. Further studies are warranted to clarify the therapeutic role of ICIs in this setting."

Checkpoint inhibition • Clinical • Journal • Real-world evidence • Clear Cell Carcinoma • Oncology • Ovarian Cancer • Solid Tumor

Immunotherapy in advanced endometrial cancer with microsatellite instability: A systematic review. (PubMed, Farm Hosp) - "The efficacy of pembrolizumab and pembrolizumab-lenvatinib regimen appears promising. However, studies with larger sample size, longer follow-up and comparative design with subgroup analysis based on differences in microsatellite repair mechanisms are needed for proper therapeutic positioning."

Journal • Review • Endometrial Cancer • Fatigue • Gastroenterology • Gastrointestinal Disorder • Microsatellite Instability • Oncology • Solid Tumor • MSI

Adverse Events of Immune Checkpoint Inhibitors in Cancer Patients with Comorbid Diabetes: A Real-World Pharmacovigilance Analysis of the FDA Adverse Event Reporting System Database (2011-2025). (PubMed, Cancer Control) - "Reports listing anti-PD-1 (Nivolumab, Pembrolizumab, Cemiplimab), anti-PD-L1 (Atezolizumab, Avelumab, Durvalumab), and anti-CTLA-4 (Ipilimumab, Tremelimumab) agents as suspected drugs were extracted. Fatal subgroup occurred sooner than non-fatal subgroup (median 106.7 vs 132.5 days; P = 0.004).ConclusionDiabetic cancer patients experienced the full spectrum of ICI-associated toxicities, with combination treatments linked to greater lethality. Multidisciplinary surveillance during the first 3-4 months of therapy, glycemic control, and long-term follow-up may be essential to optimize benefit and minimize harm in this expanding population."

Adverse events • Checkpoint inhibition • Journal • Real-world evidence • Retrospective data • Diabetes • Endocrine Disorders • Gastroenterology • Gastrointestinal Disorder • Immunology • Interstitial Lung Disease • Metabolic Disorders • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases

Geographic Differences in Immune-Related Toxicity: A Pan-Cancer Meta-Analysis of Western vs East Asian Immune Checkpoint Inhibitor Trials (2014–2024) (SITC 2025) - "Background Immune checkpoint inhibitors (ICIs) have transformed cancer therapy, but they often lead to immune-related adverse events (irAEs) that differ by region due to genetic, environmental, and practice-based factors.1 2 While prior studies suggest possible geographic variability in irAE incidence, a comprehensive cross-regional analysis across all ICI types and cancers remains lacking.Methods We conducted a pan-cancer meta-analysis of interventional trials registered on ClinicalTrials.gov between 2014 and 2024 evaluating approved ICIs (nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, ipilimumab, tremelimumab). Persistent heterogeneity across analyses (I2 > 85%) suggests the influence of unmeasured trial-level variables or differences in data completeness. To improve the interpretability and global generalizability of ICI safety data, future studies should harmonize AE reporting standards, stratify outcomes by geography and tumor type, and integrate..."

Checkpoint inhibition • IO biomarker • Pan tumor • Retrospective data • Melanoma • Oncology • Solid Tumor

Real-World Evidence Study on PD-L1 Testing and Use of Immuno-Oncology (IO) Treatments Among Cancer Patients in the Helsinki and Uusimaa (HUS) Region, Finland (ISPOR-EU 2025) - "The IO-treatments included nivolumab, pembrolizumab, durvalumab, avelumab, atezolizumab, cemiplimab, dostarlimab, ipilimumab and tremelimumab. PD-L1 testing was most frequently done in patients with melanoma, colorectal, lung, breast, kidney and bladder cancer. In this study, which is part of the Collaboration Research (CORE) dataset of Medaffcon, we show the frequency of PD-L1 testing and use of IO-treatments in HUS region, Finland. Both PD-L1 testing and use of IO-treatments were most common among lung cancer patients. We also show a notable increase in both PD-L1 testing and use of IO-treatments over time."

Clinical • HEOR • Immuno-oncology • IO biomarker • Real-world • Real-world evidence • Bladder Cancer • Genito-urinary Cancer • Kidney Cancer • Lung Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor • PD-L1

Hematological Toxicity of Immune Checkpoint Inhibitors: Real-World Retrospective Outcomes from a Cohort Study in Qatar (ASH 2023) - "Nivolumab was the most used ICPI (n=8, 57%), followed by pembrolizumab (n=4, 29%), durvalumab (n=1, 7%) and avelumab (n=1, 7%). On the other hand, our population is slightly different with the majority of cases described here being non-melanoma solid malignancies. Considering the rate of Hem-irAEs in the investigated population at NCCCR, there is a need for an integrated pathway for the diagnosis and management of these events."

Checkpoint inhibition • Real-world • Real-world evidence • Retrospective data • Anemia • CNS Disorders • Dermatitis • Dermatology • Endocrine Disorders • Eosinophilia • Hematological Disorders • Hepatology • Immunology • Neutropenia • Non-melanoma Skin Cancer • Solid Tumor • Thrombocytopenia

Immune checkpoint inhibitors and hemophagocytic lymphohistiocytosis: Disproportionality analysis from FAERS (ESMO-IO 2025) - "Cases were grouped by PD-1 inhibitors (pembrolizumab, nivolumab, cemiplimab, sintilimab, tislelizumab, camrelizumab, retifanlimab, toripalimab) and PD-L1 inhibitors (atezolizumab, durvalumab, avelumab). Clinicians should remain vigilant for HLH—especially early fever, cytopenias, and rising ferritin—and seek prompt hematology input with diagnostic workup, which may be lifesaving. Differences may reflect pharmacodynamics, indication mix, combinations, and reporting bias; prospective, mechanism-focused studies are needed to clarify causality and guide mitigation strategies.Legal entity responsible for the study The authors."

Checkpoint inhibition • Breast Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Trends in usage and drug costs of immune checkpoint inhibitors in Japan. (PubMed, Jpn J Clin Oncol) - "Drug costs for ICIs are significantly increasing despite the Japanese government's frequent efforts to reduce ICI drug prices. The elderly population made up a particularly high proportion of those burdened with the higher costs. Healthcare economic policies are warranted to ensure efficient distribution of budgetary resources."

Checkpoint inhibition • HEOR • Journal • Oncology

Kidney Outcomes Associated with Immune Checkpoint Inhibitor Therapy in Patients with Cancer: A Global Cohort Analysis Using TriNetX (KIDNEY WEEK 2025) - "Cohort A (n=38,530) included patients treated with an FDA-approved ICI (atezolizumab, durvalumab, nivolumab, pembrolizumab, ipilimumab, avelumab, cemiplimab). While ESRD was less common in the ICI group, the higher incidence of acute and immune-mediated renal syndromes warrants careful monitoring of kidney function in patients undergoing ICI therapy. Prospective studies are needed to clarify causality and identify modifiable risk factors."

Checkpoint inhibition • Clinical • Acute Kidney Injury • Chronic Kidney Disease • Glomerulonephritis • Nephrology • Oncology • Renal Disease

Immune Checkpoint Inhibitor-Induced Miller Fisher Syndrome: A Case of Relapsing Symptoms Requiring a Slow Corticosteroid Taper. (PubMed, Cureus) - "We report the first fully described case of avelumab (a programmed death-ligand 1 (PD-L1) inhibitor)-associated MFS, highlighting its rarity and relapsing course...Similar MFS presentations have been described with programmed cell death protein 1 inhibitors (such as pembrolizumab) but not previously with PD-L1 blockers. This case expands the spectrum of ICI-associated neuropathies, emphasizing that MFS due to PD-L1 inhibition may occur despite negative antibodies and subtle neurophysiological findings. Early immunosuppression, cautious corticosteroid tapering, and close multidisciplinary collaboration are essential for achieving sustained neurological and oncologic recovery."

Checkpoint inhibition • Journal • Ataxia • CNS Disorders • Movement Disorders • Ophthalmology