Opdivo (nivolumab) / Ono Pharma, BMS - LARVOL DELTA

Radiation-free therapy for the initial treatment of good prognosis early non-bulky HL, defined by a low metabolic tumor volume and a negative interim PET after 2 chemotherapy cycles. a phase II prospective rafting trial (ASH 2025) - P2 | "The planned treatment for VLR/LR pts consist of CT alone and in case of LimRel salvage with INRT+Nivo, whereas for HR "triple therapy". The other secondary endpoints include 3-year OS and accuracy of ctDNA for relapse detection in VLR/LR pts.The RAFTING trial is approved by IRB of Medical University of Gdańsk, Poland (NKBBN/74/2021) and is funded by the Medical Research Agency, Poland (Project 2019/ABM/01/00060)."

Clinical • P2 data • Cardiovascular • Classical Hodgkin Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

Transfusion burden across hematologic and solid tumors: A real-world comparative study in AML, multiple myeloma, lung cancer, and melanoma (ASH 2025) - "In parallel, patients with lung cancer or melanoma receiving immune checkpoint inhibitors (ICIs)—nivolumab or pembrolizumab—were followed for 30 days, reflecting delayed hematologic effects...The AML transfusion rate exceeds that seen in phase 3 venetoclax trials, suggesting a greater real-world demand for hematologic support...Such tools could inform real-time transfusion protocols, trigger-based monitoring, or risk-adapted care pathways—particularly in settings with constrained supportive care resources. Future directions include integrating transfusion need into clinical risk models, exploring its role in treatment response prediction, and tailoring supportive care strategies accordingly."

Clinical • IO biomarker • Real-world • Real-world evidence • Acute Myelogenous Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Lung Cancer • Melanoma • Multiple Myeloma • Neutropenia • Oncology • Solid Tumor

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

Patterns of presentation, treatment, and survival in primary mediastinal B cell lymphoma: A colombian retrospective cohort (ASH 2025) - "R-CHOP protocol was the most common induction regimen (58.8%, n =10) followed by ABVD (23.5%, n=4), Bortezomib combined with Rituximab-Mitoxantrone (11.7%, n=2) and ICE (5,8%, n=1)...Likewise, there was a significant lack of access to Nivolumab and Brentuximab Vedotin, which has shown promising early efficacy in patients with R/R PMBCL as has been described in large clinical trials such as CheckMate 436 (Zinzani et al., 2019)... This small single center retrospective cohort study is one of the first to be conducted regarding PMBL in Latin America and to our knowledge first conducted in Colombia. Our findings regarding survival suggest efficient disease control, however with a high risk for late relapse beyond five years. In that sense, larger local real world studies are needed and it is crucial to emphasize on diagnosis and treatment strategies used in this region in order to optimize clinical outcomes in resource limited settings."

Retrospective data • B Cell Lymphoma • Cardiovascular • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Mediastinal B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Primary Mediastinal Large B-Cell Lymphoma • Respiratory Diseases • CD20 • MME • TNFRSF8

Combination of brentuximab vedotin and nivolumab in the management of Hodgkin lymphoma: A systematic review and meta-analysis (ASH 2025) - "Conclusion This meta-analysis suggests that the combination of Brentuximab Vedotin and Nivolumab may improve survival and increase the progression-free interval in patients with advanced, relapsed, or refractory Hodgkin's lymphoma, with an acceptable safety profile. Future high-quality trials with larger patient populations are needed to consolidate these findings."

Retrospective data • Review • Hematological Malignancies • Hodgkin Lymphoma • Leukopenia • Lymphoma • Neutropenia

Fulminant immune checkpoint inhibitor encephalitis associated with nivolumab: Case report and review of the literature (ASH 2025) - "Case Presentation: Within 24 hours of initiating nivolumab combined with brentuximab (an antibody-drug conjugate), a White male in his 70s with recurrent Hodgkin lymphoma and history of cutaneous T-cell lymphoma presented with altered mental status, status epilepticus, and abnormal signal in the bilateral temporal lobes on brain magnetic resonance imaging (MRI)...Following multidisciplinary consultation, the patient was ultimately diagnosed with ICI-encephalitis and begun on empiric treatment with intravenous methylprednisolone dosed 1 g/day for 5 days, followed by 5 days of intravenous immunoglobulin (IVIG)... This case serves as a safety signal for fulminant irAE following nivolumab administration. According to available literature, this represents the most rapidly-presenting case of fulminant irAE following administration of an ICI."

Case report • Checkpoint inhibition • Clinical • Review • CNS Disorders • Cutaneous T-cell Lymphoma • Epilepsy • Genetic Disorders • Hematological Malignancies • Hodgkin Lymphoma • Infectious Disease • Lymphoma • Oncology • Skin Cancer • T Cell Non-Hodgkin Lymphoma

Efficacy and safety of nivolumab-based therapies in first-line and Relapsed/Refractory Hodgkin lymphoma (ASH 2025) - "Combination regimens involving nivolumab with agents such as brentuximab vedotin (BV), AVD (adriamycin, vinblastine, dacarbazine) combination chemotherapy, and novel immunomodulators have shown promising activity. In relapsed or refractory CHL, nivolumab-based regimens are highly effective, producing durable responses and favorable survival outcomes, especially when combined with chemotherapy or antibody-drug conjugates such as BV. Although AEs are more common in multi-agent regimens, the safety profile remains acceptable. Nivolumab's role as a salvage or consolidation therapy is supported, given its relatively lower efficacy in the first-line therapeutic context."

Clinical • Classical Hodgkin Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma

High transplant conversion rates with gemcitabine, dexamethasone and carboplatin (GDP)-based therapy in Relapsed/Refractory lymphoma: A real-world experience (ASH 2025) - "G-CSF and Plerixafor-mobilized peripheral blood stem cell were used in all patients...Eligible patients received agents like Rituximab, Brentuximab, and Nivolumab with additional cost per cycle...The regimen's daycare feasibility and reduced hospitalization needs offer significant quality-of-life and economic advantages. Substituting Carboplatin for Cisplatin further enhances administration convenience."

Clinical • Real-world • Real-world evidence • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Thrombocytopenia • Transplantation

Checkpoint inhibitors improve progression free survival after autologous transplant despite poorer pre-transplant response (ASH 2025) - "Introduction The checkpoint inhibitors (CI) nivolumab and pembrolizumab which target PD1 are established treatments for relapsed/refractory classic Hodgkin Lymphoma (cHL)...44 received brentuximab vedotin (BV)...All patients were conditioned with LEAM (lomustine, etoposide, cytarabine, melphalan)...CI treatment prior to ASCT may alter cHL disease biology leading to increased sensitization to subsequent high dose cytotoxic chemotherapy although more exploratory data assessing the mechanism is needed. We are planning a multi-centre analysis to investigate further."

Checkpoint inhibition • Pre-transplantation • Cardiovascular • Classical Hodgkin Lymphoma • Diabetes • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Hodgkin Lymphoma • Immunology • Lymphoma • Metabolic Disorders • Oncology • Pneumonia • Transplantation

Treatment practices and outcomes of advanced stage classical Hodgkin lymphoma in India: An analysis from the hematology cancer consortium (ASH 2025) - "Other regimens included BEACOPP (n=39; 5.5%), platinum-based protocols (n=8; 1.1%), and regimens with Brentuximab Vedotin (n=3; 0.4%) or Nivolumab (n=7; 1.0%)...Bleomycin toxicity was reported in 48 (7%) patients and 4 patients succumbed to the same...iPET response was the strongest predictor of event-free survival, outperforming traditional prognostic markers like the IPS score. Combining iPET and IPS can be further used to stratify risk, though this requires validation in prospective cohorts."

Metastases • Classical Hodgkin Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

Progress in immunotherapy for resectable head and neck squamous cell carcinoma. (PubMed, Med Oncol) - "This report conducts a systematic review of four principal studies: ① The KEYNOTE-689 trial was the inaugural study to establish that "pembrolizumab combined with standard therapy" diminishes the risk of disease progression or mortality by 34% in patients with Programmed Cell Death-L1(PD-L1) CPS ≥ 10, resulting in Food and Drug Administration (FDA) approval; ② The NIVOPOSTOP trial revealed that adjuvant nivolumab alongside CRT significantly improved 3-year disease-free survival (DFS) (63.1% vs. 52.5%), with efficacy unaffected by PD-L1 status; ③ The C-POST trial indicated a substantial DFS advantage with adjuvant cemiplimab in high-risk skin squamous cell carcinoma (HR = 0.32);④ The NeoRTPC02 trial innovatively integrated low-dose radiotherapy with immune chemotherapy, achieving a pathological complete response(pCR) rate of 60.9%. Nonetheless, the ideal treatment approach, strategies for reducing radiation dosage, preservation of organ function, and selection..."

IO biomarker • Journal • Review • Head and Neck Cancer • Non-melanoma Skin Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • PD-L1

A nyelőcső-, GEJ- és gyomordaganatok immunterápiája. (PubMed, Magy Onkol) - "In esophageal tumors, adjuvant nivolumab is used. Among HER2-positive patients, adding pembrolizumab to trastuzumab and chemotherapy - in PDL1 CPS ≥1 cases - has become a new standard. A special mention must be made of MSI-H tumors, in which immunotherapy is highly effective, and adjuvant chemotherapy is not recommended according to current guidelines."

Journal • Review • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Microsatellite Instability • Oncology • Solid Tumor • HER-2 • MSI

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

Neoadjuvant nivolumab plus carboplatin and paclitaxel in patients with locally advanced resectable squamous cell carcinoma of the head and neck: a phase II, single-arm trial. (PubMed, Clin Cancer Res) - "This phase II trial of neoadjuvant nivolumab plus carboplatin and paclitaxel in previously untreated, locally-advanced, resectable SCCHN was well tolerated and reached its primary endpoint of pCR at the primary site. A phase III confirmatory study is warranted in advanced-stage, resectable HPV-negative SCCHN."

Journal • P2 data • Head and Neck Cancer • Oncology • Oral Cancer • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Checkpoint inhibitors exposure does not affect survival and safety in PMBCL patients receiving CAR T-cells therapy: An analysis of the italian CART-SIE study (ASH 2025) - "Among the 1309 patients (pts) enrolled in the study, 93 with R/R PMBCL whoreceived axicel (n=90) or lisocel (n=3) were eligible for this analysis...The type of CPI used,Nivolumab or Pembrolizumab, had no impact on either OS or PFS...Findings ofthis study suggest that the use of CPI is safe and may be beneficial as part of salvage therapy to improvedisease control before infusion or to rescue patients following CAR T-cell failure. Due to the limitednumber of patients experiencing CAR T-cell failure, the optimal salvage strategy in this setting remainsundetermined."

CAR T-Cell Therapy • Checkpoint inhibition • Clinical • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Mediastinal B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma

Patterns, risk factors and management of CD19-directed chimeric antigen receptor T-cell therapy failure in CNS lymphoma (ASH 2025) - "Notably,peripheral CD19+-B-cell aplasia suggested persistence of CD19-CAR T-cells in 93% of patients at PD.Salvage immune checkpoint inhibition (pembrolizumab, nivolumab), and lenalidomide with rituximab ortafasitamab yielded prolonged responses in a subset of patients, often exceeding 5 months... Our study identifies novel radiological risk factors for CD19-CAR failure in patients withCNSL, namely peripheral CE and LMD prior to CD19-CAR, which may guide prognostic stratification atbaseline. Outcome after CD19-CAR failure remains poor, underlining the need for rational salvagetreatments. In patients progressing after CD19-CAR therapy, we noted encouraging responses aftersalvage ICI and lenalidomide combined with rituximab/tafasitamab, which warrant further investigationin prospective studies."

CAR T-Cell Therapy • Clinical • IO biomarker • CNS Disorders • CNS Lymphoma • Hematological Malignancies • Lymphoma

Bone marrow spatial architecture predicts response duration in smoldering multiple myeloma patients receiving checkpoint inhibitor therapy (ASH 2025) - P2 | "MethodsWe analyzed 15 BM trephine biopsies from high-risk SMM patients enrolled in a phase II trial ofnivolumab combined with lenalidomide and dexamethasone (NCT02903381). CN3demonstrates strategic positioning of immune cells with controlled spacing between inflammatorypopulations, providing spatial evidence of a "regulated inflammatory state." Our findings indicate thatspatial orchestration of immune cells serves as a critical biomarker of therapeutic response in checkpointinhibitor therapy.ConclusionsOur findings suggest that baseline spatial organization, particularly the CN3 neighborhood characterizedby strategic positioning of M1-like macrophages and exhausted CD8 T cells, may be associated withtreatment duration. While limited by sample size, these preliminary results suggest that spatial analysisof BM biopsies could provide novel insights into immune dynamics in multiple myeloma and may informfuture therapeutic strategies in this patient population."

Checkpoint inhibition • Clinical • IO biomarker • Hematological Malignancies • Multiple Myeloma • Neutropenia • Oncology • Smoldering Multiple Myeloma • Solid Tumor • CD8

Long term follow up autologous CD30.CAR-T cells in combination with nivolumab in patients with relapsed or refractory classical Hodgkin lymphoma after failure of frontline therapy (ASH 2025) - "Trial design was treatment with 4 cycles of nivo,followed by a single infusion of CD30.CAR-T preceded by lymphodepletion with bendamustine andfludarabine...Grade 1 CRS wasobserved in 1 pt (8%), resolving without use of steroid or tocilizumab...Further larger studies are neededfor confirmation; however, for a carefully selected pt population, CD30.CAR-T with nivo shows a favorableduration of response. Correlative data will be available at time of presentation."

CAR T-Cell Therapy • Clinical • Combination therapy • IO biomarker • Classical Hodgkin Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Infectious Disease • Lymphoma • PD-L1 • TNFRSF8

Cancer specific risk and mortality due to autoimmune hemolytic anemia (AIHA) associated with immune checkpoint inhibitors (ICI) (ASH 2025) - "Given the elevated risk observedin melanoma, we also evaluated patients treated with the combination of nivolumab andipilimumab, a common regimen for this population...Thedevelopment of AIHA is associated with markedly increased short term and long-term mortalityacross multiple cancer subtypes with most pronounced impact on GU and lung cancers. Thefindings highlight the need for increased vigilance, early recognition and proactive managementof AIHA in patients receiving ICI therapy."

Checkpoint inhibition • Anemia • Autoimmune Hemolytic Anemia • Gastrointestinal Cancer • Genito-urinary Cancer • Hematological Malignancies • Immunology • Lung Cancer • Melanoma • Oncology • Solid Tumor • HP

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

A phase II Study of fedratinib and nivolumab combination in patients with myelofibrosis and resistance or suboptimal response to JAK-inhibitor treatment – fraction Study / IKF051 / gsg-MPN-006 (ASH 2025) - "Introduction: Early clinical trials for patients with myelofibrosis (MF) are aimed to improve treatmentusing combinatorial therapies for patients with suboptimal response to Ruxolitinib therapy. Fedratinib-Nivolumab combination demonstrates promising clinical efficacy in a cohort of MFpts enriched for int-2 or high-risk, especially in those with proliferative features indicated by leukocytosisand thrombocytosis and was well tolerated leading to prolonged treatment durations. The safety profileis consistent with prior experience. Fedratinib's unique kinase inhibition profile may provide amechanism for enhanced effectiveness in this pt population."

Clinical • IO biomarker • P2 data • Hematological Disorders • Myelofibrosis • Thrombocytopenia • Thrombocytosis • JAK2 • PD-L1

Molecular determinants of therapeutic response to nivolumab in Relapsed/Refractory PTCL: An integrated multiomic study of A phase II investigator-initiated trial (ASH 2025) - P | "Although the pre-specified efficacy threshold (ORR 30%) was not met, Nivolumabmonotherapy induced durable disease controls in 3 (15.8%) patients with r/r PTCL, including 2 (10%)patients with PRs. Durable disease controls were associated with PD-L1/2 and PTPRD mutations, higherTMB, and increased cfTCR diversity. We also observed augmented turnover of both tumor cells and non-tumor immune cells in responders."

IO biomarker • P2 data • Tumor mutational burden • Breast Cancer • Extranodal Natural Killer/T-cell Lymphoma • Hematological Malignancies • Infectious Disease • Lymphoma • Peripheral T-cell Lymphoma • Solid Tumor • T Cell Non-Hodgkin Lymphoma • ALK • CD8 • PD-L1 • PD-L2 • PTPRD • TMB

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