Yervoy (ipilimumab) / Ono Pharma, BMS - 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

A retrospective chart review of UK patients with advanced renal cell carcinoma treated with nivolumab plus ipilimumab. (PubMed, Future Oncol) - "Median OS was not reached in patients who received NIVO+IPI plus NIVO maintenance and patients with prior nephrectomy. Patients who received NIVO+IPI with NIVO maintenance and patients who had undergone prior nephrectomy experienced the most favorable survival outcomes, aligning with results from previous studies."

Journal • Retrospective data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Immune effector cell-associated enterocolitis (IEC-EC) across CAR-T products in myeloma and lymphoma: A real world pharmacovigilance analysis (ASH 2025) - "Introduction: IEC-EC has emerged as a unique toxicity of BCMA-targeted CAR-T therapy in multiple myeloma (MM)patients (pts), most commonly with ciltacabtagene autoleucel (cilta-cel) (G...Reports were distributed as follows: axicabtagene ciloleucel (axi-cel, 57.6%,n=7828), cilta-cel (19.5%, n=2647), brexucabtagene autoleucel (brexu-cel, 11.9%, n=1615), idecabtagenevicleucel (ide-cel, 6.9%, n=933), and lisocabtagene maraleucel (liso-cel, 4.7%, n=641)...Compared with checkpoint inhibitors, cilta-cel-associated IEC-EC rates (1.02%) exceeded those for the PD-1 agents nivolumab (0.23%), pembrolizumab(0.13%) and the CTLA-4 inhibitor ipilimumab (0.46%)... Our PV analysis reveals distinct GI SAE profiles among CAR-T therapies, with cilta-cel demonstrating aparticularly high signal for IEC-EC (ROR: 126.35, p<0.001). However, 3 cases occurred with axi-cel as well.The reported colitis rates well exceeded those observed with established checkpoint inhibitors,suggesting unique..."

Adverse events • Clinical • Real-world • Real-world evidence • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Immunology • Lymphoma • Multiple Myeloma

Immune checkpoint inhibitor–associated cytopenias: A decade of real-world signal detection from faers (2014–2025) (ASH 2025) - "Nivolumab, pembrolizumab,and atezolizumab accounted for over 85% of these cases...Other notable signalsincluded durvalumab with pancytopenia (ROR 1.67), ipilimumab with thrombocytopenia (ROR 1.43), andpembrolizumab with AIHA (ROR 1.74)...In this decade-long pharmacovigilance analysis, hematologic irAEs, particularly AIHA and ITP, weredisproportionately associated with ICIs, most notably anti–PD-L1 agents. Most occurred with combinationregimens, but monotherapy regimenss were not exempt. Our findings emphasize the importance ofearly recognition, diagnostic evaluation, and multidisciplinary management of new-onset cytopeniasduring immunotherapy."

Checkpoint inhibition • Clinical • Real-world • Real-world evidence • Agranulocytosis • Anemia • Aplastic Anemia • Autoimmune Hemolytic Anemia • Granulocytopenia • Immune Thrombocytopenic Purpura • Immunology • Neutropenia • Oncology • Thrombocytopenia • Thrombocytopenic Purpura • ROR1

Incidence and clinical outcomes of hematologic immune-related toxicities in patients with solid malignancies treated with immune checkpoint inhibitors (ASH 2025) - "Specific ICI agents included nivolumab (60.7%), atezolizumab (19.3%), and durvalumab(18.4%); and 21.4% of patients received more than one...Preceding ICI therapyincluded pembrolizumab (n=2), nivolumab (n=1) and combination nivolumab/ipilimumab (n=1).Mean time to development of irAE was 75.8 days (ranging from 29 days to 144 days)...Although no irAE ITP or TTP cases were identified, alterations in hematologicparameters are common in malignancy, including from chemotherapy or the cancer itself, sosome may have gone unrecognized. HIT was diagnosed in two cases shortly after ICI initiation.These data highlight the need for multicenter databases employing a systematic approach tocapture and characterize hematologic irAEs across diverse patient populations."

Checkpoint inhibition • Clinical • Clinical data • Autoimmune Hemolytic Anemia • Biliary Cancer • Immune Thrombocytopenic Purpura • Immunology • Infectious Disease • Lung Cancer • Melanoma • Oncology • Pneumonia • Respiratory Diseases • Septic Shock • Solid Tumor • Thrombocytopenia • Thrombocytopenic Purpura

Nivolumab and pembrolizumab in treatment of relapsed or refractory classical Hodgkin lymphoma: Systematic review and meta-analysis of clinical trials (ASH 2025) - "Managementinvolves platinum/gemcitabine-based chemotherapy, brentuximab vedotin (BV), autologous stem celltransplant (ASCT), or PD-1 inhibitors that have led to improved outcomes in the past decade...Nivolumab andpembrolizumab monotherapies were investigated in 5 and 3 trials, respectively; BV with nivolumab wasstudied in 2 trials, the rest of the studies evaluated different combinations of immune-chemotherapies(n=2) or different immunotherapies (n=4), such as ipilimumab (±BV) and lirilumab... This meta-analysis confirms that both pembrolizumab and nivolumab in the treatment ofr/r cHL similarly improve clinical outcomes with an acceptable safety profile. As the treatment landscapeof r/r cHL evolves and with the Introduction of PD-1 inhibitors in the frontline setting, the efficacy of theseagents in combination with other treatment modalities, including emerging immunotherapeutic agents,should be investigated. Patients with multiple comorbidities, prior..."

Retrospective data • Review • Classical Hodgkin Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Human Immunodeficiency Virus • Infectious Disease • Lymphoma

Real-world burden and risk analysis of hematologic iraes in patients treated with immune checkpoint inhibitors: 5-year cohort study (ASH 2025) - "Hence, we evaluated the frequency, spectrum, and risk factors of hematologicirAEs in patients with melanoma, renal cell carcinoma, or urothelial carcinoma treated with ICIs at atertiary cancer center.Methods We conducted a single-center, retrospective cohort study at the American University of Beirut MedicalCenter (AUBMC), including adult patients (N = 116) who received at least one dose of ipilimumab,nivolumab, pembrolizumab, atezolizumab, or durvalumab between January 1, 2019, and January 31,2024. Although usually rare in literature, we found hematologic irAEs to be common but mild and manageablewith ICIs. No significant predictors were identified. Early monitoring and supportive care are key."

Checkpoint inhibition • Clinical • Real-world • Real-world evidence • Autoimmune Hemolytic Anemia • Genito-urinary Cancer • Hematological Malignancies • Immunology • Melanoma • Myelodysplastic Syndrome • Neutropenia • Oncology • Renal Cell Carcinoma • Solid Tumor • Thrombocytopenia • Urothelial Cancer

Mechanisms of immune escape and altered tissue homing in leukemia cutis (ASH 2025) - "Onset of LC associated with reduced WT1-specific T cells (1.7% vs 0.8%),while nivolumab led to re-expansion (1.2%). Following ipilimumab and until further LC progression, WT1-specific T cells contracted once again (0.8%), demonstrating associations with the clinical course...In sum, we provide a comprehensive single-cell characterization of LC, uncovering immune evasion,altered homing, and T cell exhaustion, highlighting fundamental differences between medullary andextramedullary AML. This sets the stage for future studies to dissect tissue-specific leukemic niches andinforms rational design of immunotherapies."

IO biomarker • Acute Myelogenous Leukemia • Hematological Malignancies • Immunology • Leukemia • CD31 • CD8 • CXCL13 • ICAM1 • ITGA4 • ITGA5 • ITGA6 • ITGB2 • ITGB4 • LAG3 • PECAM1 • WT1

Long-term follow up of nivolumab/ipilimumab-primed immunotransplant in patients with Relapsed/Refractory DLBCL (ASH 2025) - P1 | "On day -54,patients received rituximab 375mg/m2, followed by two cycles of DCB (ipilimumab 1mg/kg andnivolumab 3mg/kg q3weeks, starting on day -53), followed by rituximab on day -11 and peripheral bloodT-cell harvest. Patients underwent lymphodepletion on day -5 to -3 with fludarabine 30mg/m2/d andcyclophosphamide 500mg/m2/d, followed by autologous T-cell transfer of DCB-primed T cells (IT) on day0... Although DCB has been shown to be minimally effective in r/r DLBCL, DCB-primedimmunotransplant, a multi-modal approach to augment responsiveness and overcome T-cell exhaustion,led to durable remissions in heavily pre-treated DLBCL patients without subsequent systemic therapy. Further investigation of DCB-primed immunotransplant may uncover efficacy for common tumor typesin which DCB has proven ineffective."

Clinical • Anorexia • B Cell Lymphoma • Constipation • Diffuse Large B Cell Lymphoma • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Pulmonary Disease • Transplantation • IL15 • IL7

P156 Neoadjuvant immunotherapy for advanced melanoma: a clinical audit of pathological response and toxicity. (PubMed, Br J Dermatol) - "Fourteen received pembrolizumab and four received ipilimumab plus nivolumab, with all patients receiving between two and four cycles. These results differ from the more promising findings in the SWOG S1801 and OpACIN-neo trials, which followed 313 and 86 eligible patients, respectively. Further patient enrolment is needed to accurately assess the risk-benefit profile of neoadjuvant immunotherapy in melanoma management."

IO biomarker • Journal • Dermatitis • Dermatology • Endocrine Disorders • Gastroenterology • Gastrointestinal Disorder • Immunology • Melanoma • Oncology • Rheumatology • Solid Tumor

Beyond the Skin: A Rare Case of Primary Malignant Melanoma of the Lung. (PubMed, Cureus) - "Given the tumour's unresectable nature due to proximity to critical mediastinal structures and the patient's comorbidities, she was initiated on a modified combination immune checkpoint inhibitor regimen with nivolumab and ipilimumab. This case highlights the importance of a meticulous diagnostic approach to solitary pulmonary lesions and underscores the evolving role of immunotherapy in managing rare malignancies such as PMML. Reporting such cases enhances the clinical understanding and guides future management of this rare disease."

IO biomarker • Journal • Cough • Melanoma • Oncology • Ophthalmology • Rare Diseases • Respiratory Diseases • Solid Tumor • BRAF • KIT • NRAS • SOX10

BI12 Systematic review of checkpoint inhibitor-induced epidermal necrolysis: a clinical entity distinct from 'classic' Stevens-Johnson syndrome/toxic epidermal necrolysis. (PubMed, Br J Dermatol) - "We identified 39 patients who developed ICI-induced SJS/TEN following treatment with either pembrolizumab, nivolumab, atezolizumab or nivolumab-ipilimumab combination. This review of recently published cases reinforces the concept that ICI-EN, although resembling SJS/TEN, possesses unique and idiosyncratic features. There is a need for a greater understanding of the clinical and immunological phenotype of ICI-EN, particularly the prebullous phase, to aid with prophylaxis and management."

Checkpoint inhibition • Journal • Review • Atopic Dermatitis • Dermatology • Immunology • Mucositis • Oncology • Steven-Johnson Syndrome • Stomatitis • Urticaria

Ipilimumab With or Without Bevacizumab in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery (clinicaltrials.gov) - P2 | N=169 | Completed | Sponsor: National Cancer Institute (NCI) | Active, not recruiting ➔ Completed | Trial completion date: Jan 2026 ➔ Jan 2025

Trial completion • Trial completion date • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor • BRAF

Evaluating Length of Treatment With PD-1/PD-L1 Inhibitor in Advanced Solid Tumors (clinicaltrials.gov) - P3 | N=161 | Completed | Sponsor: Dan Zandberg | Recruiting ➔ Completed | N=578 ➔ 161 | Trial completion date: Nov 2031 ➔ Nov 2025 | Trial primary completion date: Nov 2030 ➔ Oct 2025

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Anal Carcinoma • Biliary Cancer • Bladder Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Kidney Cancer • Lung Cancer • Melanoma • Merkel Cell Carcinoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Soluble immune checkpoint factors in patients with non-small cell lung cancer who received anti-CTLA-4 antibody plus anti-PD-1 antibody (ESMO Asia 2025) - "In contrast to the previous results on anti-PD-1/L1 antibody monotherapy, soluble immune checkpoint factors were not associated with treatment outcomes in patients with NSCLC who treated with the combination of ipilimumab plus nivolumab. Further studies are needed to use the soluble immune checkpoint molecules as biomarkers for identifying patients who require anti-CTLA-4 antibodies in addition to anti-PD-1 antibodies."

Clinical • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Long term real-world outcomes of first-line immunotherapy (IO) and vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI) combination in metastatic clear cell renal cell carcinoma (mRCC): Does the type of IO or VEGF-TKI matter? (ESMO Asia 2025) - "Background: First-line treatment of mRCC involves a combination of IO with a VEGF-TKI, or dual IO using nivolumab + ipilimumab...31 (60%) patients received nivolumab and 21 pembrolizumab, while the VEGF-TKI was lenvatinib in 34 (65%) and axitinib in 18... The combination of IO and VEGF-TKIs demonstrated robust efficacy in our mRCC cohort, with high ORR, minimal primary progression, and favourable survival. We recommend using IO in combination with a VEGF-TKI, based on availability, side-effects and experience, as no significant differences were observed between individual IO agents or VEGF-TKIs. Grade 3/4 IRAEs may occur, highlighting the need for early detection and timely intervention."

Clinical • Metastases • Real-world • Real-world evidence • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Peripheral blood-included and tumor-infiltrated eosinophils may be predictor for severe immune-related adverse events in patients with renal cell carcinoma with ipilimumab plus nivolumab (ESMO Asia 2025) - "We found that increased peripheral blood-included and tumor-infiltrated eosinophil may predicts severe irAEs, which are associated with poor prognoses, in patients with RCC treated with ipilimumab plus nivolumab."

Adverse events • Clinical • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Immune-related adverse events associated with first-line immune checkpoint inhibitors-based therapy for metastatic renal cell carcinoma (ESMO Asia 2025) - "Background: To assess Immune-related toxicity and safety of first-line immune checkpoint inhibitors-based therapy in metastatic renal cell carcinoma (mRCC) patients treated in real-world clinical practice. The retrospective study included data of 194 patients ≥18 years, with verified mRCC, treated with upfront combined immunotherapy, IO-IO (nivolumab + ipilimumab, 94 (48.5%) patients) or immune-targeted therapy, IO-TKI (100 (51.5%) patients: pembrolizumab + axitinib (85 (43.8%)) or lenvatinib (10 (5.2%)), nivolumab + cabozantinib (5 (2.6%)) from 07.07.2019 to 22.10.2024 at Moscow City Hospital named after S.S. Yudin... Real-world practice data confirmed results of randomized trials regarding with irAEs rate and spectrum but demonstrated higher severe and multiple irAEs frequency in mRCC patients treated with upfront immune checkpoint inhibitors-based therapy. IO-IO was associated with higher rate of multiple irAEs and immune-related renal toxicity comparing IO-TKI."

Adverse events • Checkpoint inhibition • Clinical • Metastases • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Plasma-based assessment of microsatellite instability in metastatic castration-resistant prostate cancer using the PCF_SELECT targeted capture panel (ESMO Asia 2025) - P, P2 | "Clinical trial identification: NEPTUNES - Nivolumab and Ipilimumab Treatment in Prostate Cancer With an Immunogenic Signature. The PCF_SELECT targeted panel can determine MSI status, adding to its existing applications in assessing genomic alterations in metastatic PC. Although results require confirmation across larger cohorts, our findings provide further demonstration of its broad utility as a non-invasive and clinically-relevant PC assay."

IO biomarker • Metastases • Tumor mutational burden • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Microsatellite Instability • Oncology • Prostate Cancer • Solid Tumor • MSI • TMB

Comparative efficacy and safety of pembrolizumab versus ipilimumab in advanced melanoma: A Systematic review and meta-analysis of randomized controlled trials (ESMO Asia 2025) - "Pembrolizumab demonstrated superior survival and response outcomes versus ipilimumab in advanced melanoma, with a favorable early safety profile. Limitations include heterogeneity in follow-up durations and lack of biomarker-stratified analyses. Future studies should evaluate long-term toxicity and combinatorial strategies in biomarker-defined subgroups."

IO biomarker • Metastases • Retrospective data • Review • Melanoma • Oncology • Solid Tumor • BRAF

Overall efficacy outcomes of nivolumab plus ipilimumab by occurrence of immune-mediated adverse events (IMAEs) and additional safety from Asian patients in CheckMate 9DW (ESMO Asia 2025) - P3 | "Background: In the phase 3 CheckMate 9DW trial, at a median follow-up of 35.2 months (mo), first-line nivolumab + ipilimumab (NIVO + IPI) showed significant overall survival (OS) benefit (median, 23.7 mo vs 20.6 mo; HR, 0.79 [95% CI, 0.65–0.96; P = 0.018]), higher objective response rate (ORR; 36% vs 13%; P < 0.0001) by blinded independent central review (BICR), and manageable safety vs lenvatinib (LEN) or sorafenib (SOR) in patients (pts) with unresectable hepatocellular carcinoma (uHCC). NIVO + IPI showed durable responses and long-term survival benefit regardless of IMAEs. IMAEs in Asian pts treated with NIVO + IPI occurred early and were manageable, consistent with the overall population. These results further support NIVO + IPI as a standard of care in uHCC."

Adverse events • Clinical • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology

Successful Steroid Pulse Therapy in Suspected Immune Checkpoint Inhibitor-Associated Myocarditis With Isolated Troponin Elevation. (PubMed, JACC Case Rep) - "Even in asymptomatic patients, early corticosteroid therapy should be considered for isolated cTn elevation suggesting ICI-associated myocarditis. Institutional awareness and preparedness for early intervention are crucial for effective allocation of short-term intensive medical resources."

Checkpoint inhibition • Journal • Cardiovascular • Esophageal Cancer • Inflammation • Oncology

Efficacy and CNS Toxicity of Nivolumab and Ipilimumab in Rare Cancer Brain Metastases: A Multi-Center Basket Trial Analysis (NCI/SWOG S1609). (PubMed, Clin Cancer Res) - P2 | "Dual-ICI therapy showed comparable efficacy and safety in patients with and without BM."

Journal • Pan tumor • Brain Cancer • Oncology • Solid Tumor

Phase 2 study of cabozantinib (Cabo) combined with ipilimumab (Ipi)/nivolumab (Nivo) and transarterial chemoembolization (TACE) in patients with liver limited unresectable hepatocellular carcinoma (uHCC). (ASCO-GI 2026) - "Funded by UCI Health Chao Family Comprehensive Cancer Center , Exelixis Clinical Trial Registration Number: 04472767 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • P2 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor