Imjudo (tremelimumab-actl) / AstraZeneca, Pfizer - 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

TREMENDOUS-2: An open-label, multi-center phase II study of durvalumab and tremelimumab with lenvatinib as first-line treatment in patients with unresectable hepatocellular carcinoma (ESMO Asia 2025) - P2, P3 | "Background: In the global phase III HIMALAYA study (NCT03298451), a single, high priming dose of tremelimumab (anti-CTLA4) plus durvalumab (anti-PD-L1) termed STRIDE demonstrated statistically significant and clinically meaningful improvement in OS vs. sorafenib for the 1L treatment of pts with unresectable hepatocellular carcinoma (uHCC) (median OS of 16.4 vs. 13.8 months, HR=0.78), with a manageable safety profile. The key secondary endpoint is Grade ≥3 treatment-related adverse events within 6 months after treatment initiation. Other secondary endpoints include OS, ORR, DOR, DCR per RECIST 1.1 and PFS per mRECIST and safety."

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

ARTEMIDE-HCC01: A phase III, randomised, open-label, sponsor-blinded, multicentre, global study of rilvegostomig in combination with bevacizumab with or without tremelimumab as first-line (1L) treatment for unresectable hepatocellular carcinoma (uHCC) (ESMO Asia 2025) - P3 | "In the randomisation period, ∼1200 patients will be randomised 1:1:1 to receive tremelimumab, rilvegostomig and bevacizumab (arm A), rilvegostomig and bevacizumab (arm B) or atezolizumab and bevacizumab (arm C) until progression/unacceptable toxicity. Other endpoints include OS (arm B vs arm C), ORR, duration of response, progression-free survival, safety and quality of life. Enrolment began May 2025 and is ongoing."

Clinical • Combination therapy • IO biomarker • P3 data • Hepatocellular Cancer • Oncology • Solid Tumor • AFP • CTLA4 • PD-L1 • TIGIT

Looking beyond drug costs in immune-oncology treatments for unresectable hepatocellular carcinoma: A Singapore healthcare perspective analysis (ESMO Asia 2025) - "Background: Tremelimumab + durvalumab (STRIDE) and atezolizumab + bevacizumab (A+B) are recommended first-line (1L) treatment options for unresectable hepatocellular carcinoma (uHCC). This study suggests that STRIDE offers cost savings over A+B related to resource use and TEAE management in the treatment of Singaporean patients with uHCC."

Drug cost • HEOR • Hepatocellular Cancer • Oncology • Solid Tumor

Clinical outcome of first-line systemic treatment in patients with hepatocellular carcinoma with portal vein thrombosis (ESMO Asia 2025) - "There were 49%, 27%, 20%, 4% of patients were treated with sorafenib (SOR), Lenvatinib (LEN), atezolizumab/bevacizumab (Atezo/Bev), and durvalumab/tremelimumab (Durva/Treme), respectively. In this real-world data, HCC with PVT had a significantly poorer prognosis compared to those without. Although, combination immune check point inhibitors had higher ORR, there was no difference in term of PFS and OS when compared with LEN or SOR."

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

Pooled efficacy and safety with tremelimumab plus durvalumab in participants (pts) with unresectable hepatocellular carcinoma (uHCC) from the mainland China extension cohort, and Hong Kong (HK) and Taiwan (TW) subgroups from the global cohort in the phase III HIMALAYA study (ESMO Asia 2025) - P3 | "Background: STRIDE (Single Tremelimumab Regular Interval Durvalumab) significantly improved overall survival (OS) vs sorafenib (S; hazard ratio [HR], 0.78) in pts with uHCC in the Phase 3 HIMALAYA study (NCT03298451). In this pooled analysis of the mainland China extension cohort and HK and TW subgroups, OS improved with STRIDE and D vs S, with manageable safety through 3 yrs of follow-up. STRIDE and D continued to show long-term survival benefit vs S in pts from HK and TW through 5-yr of follow-up. These results demonstrate a favourable risk-benefit profile for STRIDE and D in pts with uHCC in these populations."

Clinical • P3 data • Hepatocellular Cancer • Oncology • Solid Tumor

Safety results in Asian participants (pts) from the phase IIIb SIERRA study of durvalumab (D) and tremelimumab (T) as first-line (1L) treatment (tx) for pts with unresectable hepatocellular carcinoma (uHCC) and a poor prognosis (ESMO Asia 2025) - P3 | "The safety profile of STRIDE in Asian pts was manageable, despite enrolling pts with worse hepatic function, poorer ECOG PS or more advanced vascular invasion than those who are typically included in clinical trials for uHCC, and comparable to the global population of SIERRA."

Clinical • P3 data • Hepatocellular Cancer • Oncology • Solid Tumor

Safety outcomes with tremelimumab (T) rechallenge in the phase 3 HIMALAYA study of T plus durvalumab (D) in unresectable hepatocellular carcinoma. (ASCO-GI 2026) - P3 | "Funded by AstraZeneca Clinical Trial Registration Number: NCT03298451 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • P3 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Sequential transarterial chemoembolization and stereotactic body radiotherapy followed by immunotherapy using single tremelimumab regular interval durvalumab in locally advanced, unresectable HCC (START-FIT using STRIDE): A single-arm, phase II, multi-centre study. (ASCO-GI 2026) - P2 | "Clinical Trial Registration Number: NCT 04988945 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • Metastases • P2 data • Gastrointestinal Cancer • Hepatocellular Cancer

Bevacizumab-atezolizumab (B-A), durvalumab-tremelimumab (D-T) and lenvatinib (L) in advanced hepatocellular carcinoma patient therapy: An efficacy comparison study based on real-world evidence. (ASCO-GI 2026) - "The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • HEOR • Metastases • Real-world • Real-world evidence • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

ARTEMIDE-HCC01: A phase 3, randomized, open-label, sponsor-blinded, multicentre, global study of rilvegostomig in combination with bevacizumab with or without tremelimumab as first-line (1L) treatment for unresectable hepatocellular carcinoma (uHCC). (ASCO-GI 2026) - P3 | "Funded by AstraZeneca Clinical Trial Registration Number: NCT06921785 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • Combination therapy • P3 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Survival outcomes for phase II study of durvalumab (D) and tremelimumab (T) plus PET-directed chemoradiation (CRT) in patients (Pts) with esophageal adenocarcinoma (EA). (ASCO-GI 2026) - P1/2 | "Clinical Trial Registration Number: NCT02962063 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • P2 data • Esophageal Adenocarcinoma • Esophageal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

SIERRA: Durvalumab and Tremelimumab as First Line Treatment in Participants With Advanced Hepatocellular Carcinoma (HCC) (clinicaltrials.gov) - P3 | N=111 | Active, not recruiting | Sponsor: AstraZeneca | Trial primary completion date: Sep 2025 ➔ Dec 2025

Trial primary completion date • Hepatocellular Cancer • Oncology • Solid Tumor

INeOV: Immunotherapy With Neo-adjuvant Chemotherapy for OVarian Cancer (clinicaltrials.gov) - P1/2 | N=69 | Completed | Sponsor: ARCAGY/ GINECO GROUP | Active, not recruiting ➔ Completed

Trial completion • Oncology • Ovarian Cancer • Solid Tumor

Inpatient Cost of Managing Adverse Events (AEs) Associated With Immune Checkpoint Inhibitors (ICI) Approved for Advanced or Metastatic Cancers in the UK (ISPOR-EU 2025) - "Inpatient AE management costs associated with ICI therapies vary by regimen and cancer type, emphasizing the need to consider these costs in decision-making of ICI treatments."

Adverse events • Checkpoint inhibition • Clinical • Metastases • Biliary Cancer • Biliary Tract Cancer • Breast Cancer • Cervical Cancer • Endometrial Cancer • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer

T Cell Receptor and Immune Gene Expression Pharmacodynamics for Durvalumab alone and with Tremelimumab or Bevacizumab in Unresectable Hepatocellular Carcinoma. (PubMed, Clin Cancer Res) - P2 | "These findings suggest that STRIDE and D+B have distinct, and potentially complementary, mechanisms of action in uHCC."

IO biomarker • Journal • PK/PD data • Hepatocellular Cancer • Oncology • Solid Tumor • CD4 • CD8 • IFNG

Disparate patterns of disease time burden in patients with HCC on immunotherapy or tyrosine kinase inhibitors. (PubMed, JHEP Rep) - "Patients were classified based on the use of immunotherapy (nivolumab, pembrolizumab, atezolizumab, durvalumab, tremelimumab, and ipilimumab; including monotherapies or combinations) or TKIs (lenvatinib, sorafenib, cabozantinib, and regorafenib)...We demonstrated that immunotherapy was associated with higher DAH compared with tyrosine kinase inhibitor treatment, although this benefit was dampened by the occurrence of immune-related adverse events. These findings have quality-of-life implications and can be used for patient counselling."

Journal • Hepatocellular Cancer • Oncology • Solid Tumor

Systematic review on the safety and efficacy of immune checkpoint inhibitors combined with stereotactic body radiotherapy in advanced pancreatic cancer. (PubMed, Clin Exp Med) - "The 1-year OS rate was 44% for SBRT alone, compared to 8% for nivolumab + ipilimumab + SBRT, 80% for durvalumab + SBRT, and 2% for durvalumab + tremelimumab + SBRT. SBRT is an effective treatment option for APC, with a 1-year OS rate of 44% and relatively low TRAEs. The combination of durvalumab + SBRT demonstrated a promising 1-year OS rate of 80%, highlighting its potential for further investigation."

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

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

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

Volrustomig drives superior CTLA-4 blockade, induces sustained PD-1 degradation, and enhances T cell function ex vivo (ESMO-IO 2025) - "PBMCs, disaggregated tumor cells (DTCs), or human tumor slice cultures (TSCs) were treated with volrustomig or a co-formulation of a bivalent monospecific anti-PD-1 (clone LO115) and anti-CTLA-4 (tremelimumab) antibodies in the presence or absence of exogenous anti-CD3 stimulation. Ex vivo, volrustomig enhanced TIL functionality as detected by increased IFNγ secretion from non-small cell lung cancer DTCs and gastric TSCs.Conclusions Volrustomig demonstrates cooperative binding, induces sustained PD-1 degradation, and enhances IFNγ secretion in vitro, and ex vivo. These findings support volrustomig's unique mechanistic properties and underscore its differentiation from co-formulations of bivalent monospecific anti-PD-1 and anti-CTLA-4 antibodies.Legal entity responsible for the study AstraZeneca."

IO biomarker • Preclinical • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD4 • CD8 • IFNG • NCAM1

Cardiotoxicity of checkpoint inhibitor immunotherapy (ICI) in renal cell carcinoma (RCC): Real world evidence from ARTIST study (ESMO-IO 2025) - P=N/A | "Table: 229eP *Combined BNP & Trop in 9/61 pts (14.8%) ˆIpilimumab/Nivolumab, #Pembrolizumab, Repeat test not available in ¨9 pts, ¶1 pt Suspected ICI-related cardiotoxicity occurred in 3.3% (n=9/270, mean age 65.4 [48–80], 66.7% male). Ipi/Nivo was used in 6/9 pts; one pt received adjuvant Durvalumab/Tremelimumab in a clinical trial...CMR is valuable but may miss early reversible changes if steroids are started promptly. Cardiac enzymes, ECG, and ECHO remain useful first-line tools.Clinical trial identification NCT04060537.Legal entity responsible for the study The authors."

Checkpoint inhibition • Clinical • HEOR • IO biomarker • Real-world • Real-world evidence • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor