Opdivo (nivolumab)
/ Ono Pharmaceutical, BMS
- LARVOL DELTA
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June 02, 2026
Adjuvant Nivolumab vs Observation in Resected Non-Small Cell Lung Cancer: A Randomized Clinical Trial.
(PubMed, JAMA)
- P3 | "Adjuvant nivolumab was not associated with improved disease-free survival in patients with resected non-small cell lung cancer without sensitizing EGFR and ALK alterations when given after planned adjuvant chemotherapy and/or radiotherapy. Clinicaltrials.gov Identifier: NCT02595944."
Clinical • IO biomarker • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • ALK • EGFR • PD-L1
May 30, 2026
Genetic status of microsatellite instability (MSI) : impact on the occurrence of immune-related pulmonary adverse events (irAES) during treatment of metastatic colorectal cancers (mCRC) by immune checkpoint inhibitors (ICIs).
(ERS 2026)
- "Overall, 74 (43%) patients received combination therapy with nivolumab and ipilimumab, while 98 (57%) received monotherapy; repartition of treatment was well balanced between the two genotypes. The incidence of pulmonary irAES was 5% with a predominance of SG (7/9). Germline MSI status and exposure to pneumotoxic agents were identified as risk factors for SG."
Adverse events • Checkpoint inhibition • IO biomarker • Metastases • Colorectal Cancer • Infectious Disease • Microsatellite Instability • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • MSI
May 30, 2026
Drug-Induced Diffuse Interstitial Lung Diseases Associated with Oncologic Therapies: A Prospective Observational Study in a Tertiary Care Center
(ERS 2026)
- "Immunotherapy was the most prevalent class (26.5%), with pembrolizumab as the leading agent (34%), followed by durvalumab (16%) and nivolumab (14%). ConclusionsIn our study, immunotherapy was the most frequently identified cause of oncological DI-ILD. The favourable response to corticosteroid treatment highlights the need for early diagnosis and follow-up to optimise clinical management."
Clinical • Observational data • Breast Cancer • Infectious Disease • Interstitial Lung Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor
May 30, 2026
Incidence and severity of immune checkpoint inhibitor–related pneumonitis in lung cancer patients: a 10-year retrospective cohort study
(ERS 2026)
- "Nivolumab showed the highest incidence (21.7%), followed by durvalumab (11.9%), pembrolizumab (8.3%), nivolumab/ipilimumab (7.6%), cemiplimab (3.7%), and atezolizumab (3.3%). In this real-world retrospective cohort, CIP incidence was higher than that reported in pivotal clinical trials (3-5%) and was more frequent with anti–PD-1 agents. Pneumonitis severity was independent of ICI class, underscoring the need for vigilant monitoring regardless of the specific ICI used."
Checkpoint inhibition • Retrospective data • Lung Cancer • Oncology • Pneumonia • Solid Tumor
May 30, 2026
Performance of the NIVO score in predicting mortality in patients with AECOPD receiving acute Non-invasive ventilation: a single centre audit
(ERS 2026)
- "Conclusion In this single-centre audit of patients receiving acute NIV for AECOPD outside critical care, the NIVO score demonstrated effective risk stratification for inpatient and short-term mortality. Routine calculation of the NIVO score at NIV initiation may support escalation planning, prognostic discussions, and alignment of treatment decisions with patient goals in routine respiratory practice."
Clinical • Non-invasive • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases
May 30, 2026
Predictive Value of the Non-invasive Ventilation Outcomes (NIVO) Score For In-hospital Mortality in Intensive Care Unit (ICU) Patients Receiving Non-invasive Ventilation (NIV)
(ERS 2026)
- "In ICU patients receiving NIV, the NIVO score is associated with in-hospital mortality.This simple scoring test may serve as a supportive tool alongside clinical assessment in heterogeneous ICU populations with ARF Variable Survivor(n=75) Deceased(n=40) p Age,median(IQR) 71(65–80) 79(66–84.75) 0.02 Male sex,n(%) 41(66.1%) 21 (33.9%) 0.82 NIVO score,median(IQR) 3(2-3) 3,5(2-4) 0.02"
Clinical • Non-invasive • Atrial Fibrillation • Cardiovascular • Chronic Obstructive Pulmonary Disease • Critical care • Immunology • Respiratory Diseases
May 30, 2026
Comparison of immune-related adverse events of nivolumab and pembrolizumab treatment in patients with advanced non-small cell lung cancer in Kosovo: A single-center prospective study
(ERS 2026)
- "Nivolumab and pembrolizumab show comparable overall irAE rates in advanced NSCLC, with distinct toxicity profiles. Careful monitoring of irAEs remains essential in clinical practice. Declaration of Generative AI and AI-assisted technologies in the writing processDuring the preparation of this work, the author(s) used ChatGPT (OpenAI) only to shorten the abstract in accordance with ERS requirements."
Adverse events • Clinical • Metastases • Endocrine Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor
May 30, 2026
Age-stratified long-term outcomes of immune checkpoint inhibitors for stage IV melanoma and NSCLC in the Netherlands: a population-based study
(ERS 2026)
- "Melanoma treatments included nivolumab plus ipilimumab or anti-PD-1 monotherapy; NSCLC treatments included pembrolizumab with or without chemotherapy. These findings are in line with outcomes of clinical trials and show that also older patients treated with ICIs can have long-term survival. Further research is needed on predictors of ICI effectiveness."
Checkpoint inhibition • Clinical • Metastases • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor
May 30, 2026
Spatial transcriptomics of checkpoint inhibitor-associated tuberculous pleuritis shows endothelial gating and Th1 reprogramming
(ERS 2026)
- " We profiled paired pleural specimens (pre-treatment and at IRIS onset) from a patient with epithelioid malignant pleural mesothelioma who developed tuberculous pleuritis 43 days after nivolumab plus ipilimumab and later achieved pathological complete response, using the CosMx Spatial Molecular Imager (6,000-gene panel). Spatial transcriptomics suggests coordinated vascular, lymphoid and myeloid reprogramming may link tuberculosis reactivation with tumor clearance during ICI-associated IRIS."
Checkpoint inhibition • Infectious Disease • Malignant Pleural Mesothelioma • Mesothelioma • Oncology • Pleural Mesothelioma • Respiratory Diseases • Solid Tumor • Tuberculosis • CXCL9 • CXCR3 • ICAM1 • IFNG • VCAM1
July 15, 2026
Pre-Treatment Corticosteroids on Survival in Head and Neck Cancer Treated with Immune Checkpoint Inhibitors
(AAO-HNSF 2026)
- "Patients with HNC treated with ICIs (pembrolizumab, nivolumab, cemiplimab, or durvalumab) were stratified based on systemic corticosteroid exposure (prednisone, methylprednisolone, hydrocortisone, dexamethasone, or prednisolone) within three months before or up to one day after ICI initiation. Pre-treatment corticosteroid exposure is associated with inferior overall survival in patients with head and neck cancer treated with ICIs. These findings suggest corticosteroid use around ICI initiation should be minimized when clinically feasible and highlight the need for prospective studies to clarify optimal management strategies."
Checkpoint inhibition • Head and Neck Cancer • Hematological Malignancies • Oncology • Solid Tumor
July 15, 2026
Neoadjuvant Immunotherapy for Head and Neck Squamous Cell Carcinoma: Treatment Response, Complications, and De-escalation
(AAO-HNSF 2026)
- "Regimens included cemiplimab (29%), pembrolizumab/carboplatin/paclitaxel (19%), nivolumab (19%), 5-azacytidine/nivolumab (13%), or IO102-IO103 vaccine/pembrolizumab (13%). Neo-IO demonstrated substantial clinical and pathologic responses in patients with head and neck SCC, with a subset achieving CR without surgery. These preliminary data support future investigation into treatment de-escalation and multivariable analyses by regimen and tumor subtype."
Clinical • Endocrine Disorders • Head and Neck Cancer • Hepatology • Nephrology • Oncology • Pulmonary Embolism • Renal Disease • Respiratory Diseases • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck
July 15, 2026
Hydroxychloroquine Use and Survival in Immune Checkpoint Inhibitor-treated Mucosal Head and Neck Cancer
(AAO-HNSF 2026)
- "Adults with mucosal HNSCC initiating pembrolizumab or nivolumab were included. To our knowledge, this is the first large multi-institutional real-world analysis evaluating HCQ exposure during anti-PD-1 therapy in mHNSCC. We find that concurrent HCQ use was uncommon and was not independently associated with OS after adjustment for baseline health status and treatment factors. Additional prospective and mechanistic studies are needed to better define potential context-specific effects."
Checkpoint inhibition • Head and Neck Cancer • Immunology • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck
July 15, 2026
GLP-1 RA Use and Survival with PD-1 Immunotherapy for Head and Neck Squamous Cell Carcinoma
(AAO-HNSF 2026)
- "Patients who initiated pembrolizumab or nivolumab within 5 years of HNSCC diagnosis were included, and those who did not were excluded. Among patients with HNSCC, GLP-1 receptor agonist use was associated with improved OS within 1, 3, and 5 years compared with no GLP-1 receptor agonist use."
Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck
July 15, 2026
Immune-related Adverse Event Phenotypes Differentially Associate with Survival in Immune Checkpoint Inhibitor-treated Mucosal HNSCC
(AAO-HNSF 2026)
- "Adults with mHNSCC initiating pembrolizumab or nivolumab were included. In this large real-world cohort of ICI-treated mHNSCC, irAE occurrence was associated with longer OS, possibly reflecting treatment response, but associations varied substantially by irAE phenotype. These findings support interpreting irAEs by subtype rather than as a uniform prognostic signal."
Adverse events • Checkpoint inhibition • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck
July 15, 2026
Association of Immune-Related Adverse Events with Overall Survival in Head and Neck Cancer
(AAO-HNSF 2026)
- "We identified adult patients with head and neck cancer who received pembrolizumab or nivolumab. While overall irAE occurrence was not associated with OS, stratification by irAE subtype revealed differences in survival outcomes. Additionally, patients who developed irAEs within 1 year of treatment initiation had improved survival, suggesting that timing of irAE onset may also influence survival."
Adverse events • Clinical • Late-breaking abstract • Head and Neck Cancer • Oncology • Solid Tumor
September 18, 2026
Estimated Acquisition Cost Differences between Fixed and Simulated Body Weight-Based Nivolumab Dosing Using Real-World Claims Data in Japan.
(PubMed, Drugs Real World Outcomes)
- "Using real-world Japanese claims data and official drug prices, this study estimated higher acquisition costs based on observed fixed-dose quantities than those calculated for a simulated body-weight-based counterfactual at the index administration. The body-weight-based comparator was simulated for the same patients and did not represent an observed treatment group."
Journal • Real-world evidence
September 18, 2026
Controversies in the Management of Early-Stage Hodgkin Lymphoma: The Role of Radiation Therapy.
(PubMed, J Natl Compr Canc Netw)
- "Meanwhile, novel agents such as nivolumab and brentuximab vedotin have significantly advanced the treatment of advanced-stage disease and are now demonstrating promising activity in early-stage Hodgkin lymphoma. Techniques such as proton therapy, intensity-modulated RT, and image-guided RT dramatically reduce radiation exposure to healthy tissues compared with historical approaches, thereby improving the therapeutic ratio. Despite the high cure rates achieved today, clinical trials continue to explore novel and personalized approaches to achieve long-term remission without compromising quality of life."
Journal • Review • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology
September 18, 2026
Immune Checkpoint Inhibitors in Resectable and Locoregionally Advanced HNSCC: Past Lessons, Present Evidence, and Future Directions.
(PubMed, Oncologist)
- "We provide an overview of ongoing studies exploring ICI-based approaches and combinations for neoadjuvant adaptive response, surgical strategies including surgical conversion and organ preservation, and radiotherapy optimization. Additionally, we review ongoing clinical trials evaluating ICIs in combination with chemotherapy, antibody-drug conjugates, targeted therapy, radiotherapy-including stereotactic body radiotherapy (SBRT), novel ICIs, and therapeutic cancer vaccines targeting HPV or tumor neoantigens."
Checkpoint inhibition • Journal • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck
February 15, 2026
Four-Year outcomes of first-line Nivolumab plus ipilimumab for 6 months versus continuation in patients with advanced non-small-cell lung cancer Results of the randomized IFCT-1701 "DICIPLE" Phase III trial.
(PubMed, J Thorac Oncol)
- "Stopping IO combination at 6 months in DC patients showed no survival harm at 4 years, reduced severe irAEs, and delayed QoL deterioration."
Journal • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor
March 19, 2022
Neoadjuvant nivolumab (NIVO) + palbociclib (PALBO) + anastrozole (ANA) for estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2_) primary breast cancer (BC): CheckMate 7A8
(ESMO-BC 2022)
- P2 | "Neoadjuvant NIVO + PALBO + ANA showed a higher incidence of grade ≥3 hepatic TRAEs than historical single-agent safety profiles. These findings show a potential safety risk for the use of endocrine therapy with PD-1 + CDK 4/6 blockade."
Clinical • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Neutropenia • Oncology • Solid Tumor • ER • HER-2
September 02, 2026
OMEC-5: Timing of Minimally Invasive Local Treatment After First-Line Systemic Therapy in Oligometastatic Esophageal or Gastric Adenocarcinoma
(clinicaltrials.gov)
- P2 | N=290 | Recruiting | Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Phase classification: P2/3 ➔ P2 | Trial primary completion date: Jun 2031 ➔ Nov 2031
IO biomarker • Phase classification • Trial primary completion date • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Lung Cancer • Oncology • Solid Tumor • CLDN18 • HER-2 • PD-L1
September 07, 2026
Complete remission of a therapy-refractory Kaposi's sarcoma under off-label therapy with ipilimumab and nivolumab
(ADO 2026)
- No abstract available
Clinical • Kaposi Sarcoma • Sarcoma • Solid Tumor
September 21, 2022
Clinical outcomes with nivolumab/ipilimumab (nivo/ipi) with or without CBM588 in metastatic renal cell carcinoma (mRCC): Long-term follow-up of a randomized phase Ib clinical trial
(IKCS 2022)
- "Although limited by sample size, nivo/ipi/CBM588 demonstrated superior clinical activity over nivo/ipi. PFS and ORR with nivo/ipi/cbm588 also exceeded those observed with nivo/ipi in historical datasets. Larger efforts investigating gut microbiome modulation via CBM588 are warranted."
Clinical • Clinical data • P1 data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Sarcoma • Solid Tumor
July 24, 2025
Nivolumab, ipilimumab and bevacizumab together with 2 cycles of induction chemotherapy in patients with non-squamous NSCLC and untreated brain metastases (CA209-7WF/Break B5-BM-NSCLC/AIO-TRK-0220/ass)
(ESMO 2025)
- P2 | "Pts received nivolumab (360 mg, q3w), ipilimumab (1 mg/kg, q6w) and bevacizumab (400 mg, q3w) concomitantly with 2 cycles of chemotherapy [carboplatin (AUC 5, q3w) plus nab-paclitaxel (100 mg/m 2 , q1w)]. Most common adverse events grade ≥ 3 were pneumonia (6 pts), neutropenia (5 pts), alanine aminotransferase increased (4 pts), acute kidney injury (3 pts), sepsis (3 pts) and infection (3 pts). Conclusions The Break-B5 trial demonstrated promising intracranial activity in active (asymptomatic + symptomatic) BMs of NSCLC along with a manageable safety profile."
Clinical • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor
July 17, 2026
The clinical impact of adding chemotherapy to Nivolumab in previously treated esophageal squamous cell carcinoma: real-world evidence from a single-center cohort
(ESMO 2026)
- No abstract available
Clinical • HEOR • Real-world • Real-world evidence • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma
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