Bavencio (avelumab) / EMD Serono - LARVOL DELTA

Therapies in Combination or Sequentially With Tyrosine Kinase Inhibitors (TKIs) in Chronic Phase Chronic Myelogenous Leukemia Patients in CCR (ACTIW) (clinicaltrials.gov) - P1/2 | N=100 | Active, not recruiting | Sponsor: Versailles Hospital | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2023 ➔ Jun 2028 | Trial primary completion date: Nov 2022 ➔ Dec 2027

Enrollment closed • Trial completion date • Trial primary completion date • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology • ABL1 • BCR

Epigenetic Neural Score Predicts Survival Benefit from Immune Checkpoint Inhibition in Glioblastoma: Multicenter Discovery, Prospective Validation, and Clinical Utility Analysis (EANO 2026) - "Patients received neoadjuvant pembrolizumab, nivolumab, atezolizumab, or avelumab. The epigenetic neural score robustly and reproducibly identifies glioblastoma patients deriving survival benefit from ICI therapy. This biomarker enhances prognostic discrimination beyond clinical factors and demonstrates clinical utility, supporting its potential integration into future precision immunotherapy strategies."

Checkpoint inhibition • Clinical • IO biomarker • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

AMPLIFYing NEOepitope-specific VACcine responses in progressive diffuse gliomas (AMPLIFY-NEOVAC) - a randomized, multicenter phase 1 window-of-opportunity trial (NOA-21) (EANO 2026) - P1 | "The vaccine was tested with (arm 2, n = 17) or without (arm 1, n = 17) the programmed death ligand 1 (PD-L1) targeting antibody avelumab (AVE) compared to AVE alone (arm 3, n = 32) in patients with an IDH1R132H-mutated glioma WHO grade II, III or IV (2016 WHO classification) progressive after radiotherapy and chemotherapy and eligible for re-resection. Here we report on arms 1 and 2 of the trial... NOA-21 demonstrated feasibility, safety and intratumoral immunogenicity of IDH1-vac in combination with AVE in a randomized window-of-opportunity design in patients with recurrent IDH1R132H-mutated gliomas. These results demonstrate that tumor-specific T cells can be induced or amplified by vaccination, home to and expand in gliomas and benefit from targeting of the PD-1/PD-L1 axis."

Clinical • IO biomarker • Late-breaking abstract • P1 data • Brain Cancer • Diffuse Glioma • Glioma • Oncology • Solid Tumor • IDH1

Leveraging artificial intelligence to predict immune checkpoint inhibitor (ICI) efficacy in proficient MMR mCRC: Translational analyses of AtezoTRIBE and AVETRIC trials (ESMO 2025) - P2 | "Methods Lunit SCOPE IO quantified the density of lymphocytes (LC), fibroblasts (FB), macrophages (MP), tumor (TC), endothelial (EC) and mitotic (MTC) cells in cancer area (CA) and stroma (CS) on pre-treatment H&E WSIs from pts with pMMR mCRC enrolled in AtezoTRIBE (FOLFOXIRI/bevacizumab +/- atezolizumab [atezo]) and AVETRIC (FOLFOXIRI/cetuximab/avelumab) trials...In the AVETRIC cohort, WSIs from 48 pts were analyzed; 36 (75%) cases were classified as biomarker- high , with better PFS ( P = .043) and OS ( P = .053) compared to biomarker- low ones. Conclusions Our AI-derived tumour microenvironment biomarker may help to predict benefit from ICI-based treatments in pMMR mCRC, supporting further investigations of AI-powered approaches."

Checkpoint inhibition • Clinical • IO biomarker • Colorectal Cancer • Oncology

Avelumab plus cetuximab after progression on cemiplimab: sustained complete remission with dual IgG1 strategy in metastatic cutaneous squamous cell carcinoma (ADO 2026) - No abstract available

Clinical • Metastases • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Circulating tumor DNA tumor fraction as a biomarker in refractory metastatic colorectal cancer: findings from the CAVE-2 GOIM trial. (PubMed, J Liq Biopsy) - "The CAVE-2 GOIM trial investigated the role of rechallenge with cetuximab ± avelumab in patients with circulating tumor DNA (ctDNA) (assessed with the FoundationOne Liquid assay) RAS/BRAF wild type (WT) mCRC. This data suggests that a higher ctDNA shedding might better refine cancer aggressiveness and metastatic load than tumor burden. Taken together these results highlights the strong prognostic value of ctDNA TF and the potential role for treatment personalization."

Biomarker • Circulating tumor DNA • Journal • Colorectal Cancer • Oncology • Solid Tumor • BRAF

Avelumab added to FOLFIRI plus cetuximab followed by avelumab maintenance in patients with previously untreated RAS wild-type colorectal cancer: The phase-II FIRE-6 (AIO KRK-0118) (ESMO 2022) - "FOLFIRI/Cet plus avelumab is safe and feasible as no unexpected toxicities occurred. FIRE-6 avelumab confirms the efficacy with respect to tumor response and disease control of FOLFIRI plus cetuximab as first-line treatment of patients with RAS wild-type mCRC."

Clinical • P2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • RAS

A single arm phase II, multicenter trial to evaluate the clinical activity and safety of avelumab plus cetuximab in unresectable stage III or IV cutaneous squamous cell carcinoma: First results from the AliCe study (ESMO 2023) - P2 | "Table: 1087MO Baseline characteristics and outcome data SAF set (n=51) PP set (n=37) Mean age (years) 71.8 73.2 Sex female 33.3% 32.4% ECOG > = 1 37.3% 43.2% Stage (III/IV) 21.6%/78.4% 24.3%/75.7% Anogenital primary 31.4% 21.6% Prior systemic treatment 66.7% 67.6% Response rate 45.1% 56.8% Median PFS (95% CI), months 8.4 (4.5-10.2) 9.2 (8.3-12.5) Median OS (95% CI), months 17.4 (11.1-33.1) 25.4 (13.9-NR) AE > = grade 2 43 (84.3%) 32 (86.5%) Adverse drug reactions (ADR) > = grade 3 10 (19.6%) 6 (16.2%) Conclusions Avelumab plus cetuximab is a feasible treatment option in patients with cSCC. This combination shows remarkable activity even in patients in whom PD-1 blockade has low efficacy, such as anogenital cSCC, or after failure of anti-PD-1 monotherapy."

Clinical • P2 data • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Avelumab plus cetuximab after progression on cemiplimab: sustained complete remission with dual IgG1 strategy in metastatic cutaneous squamous cell carcinoma (ADO 2026) - No abstract available

Clinical • Metastases • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Avelumab-cetuximab-radiotherapy (RT) versus standards of care in patients with locally advanced squamous cell carcinoma of head and neck (LA-SCCHN): Final analysis of randomized phase III GORTEC 2017-01 REACH trial (ESMO 2024) - P3 | "In cisplatin-unfit pts, a favorable effect of adding avelumab to cetuximab-RT was seen on PFS and distant metastases but not on OS. In cisplatin-fit pts, the SOC cisplatin-RT was superior to combination of cetuximab-avelumab-RT."

Clinical • Metastases • P3 data • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Palbociclib After CDK4/6i and Endocrine Therapy (PACE): A Randomized Phase II Study of Fulvestrant, Palbociclib, and Avelumab for Endocrine Pre-treated ER+/HER2- Metastatic Breast Cancer (SABCS 2022) - "16% had 1 prior line of chemotherapy for MBC, 90% had received prior palbociclib, 4.5% ribociclib, 4.1% abemaciclib, 1.4% palbociclib and ribociclib. The observed longer PFS when a PD-L1 inhibitor was added to fulvestrant plus palbociclib is an intriguing signal in this ER+ population. Translational studies of blood and tumor tissue are ongoing and will be presented."

Clinical • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • CDK4 • ER • HER-2

A phase II (Alliance/A091802) randomized trial of avelumab plus cetuximab vs. avelumab alone in advanced cutaneous squamous cell carcinoma (cSCC). (ASCO 2025) - P2 | "Avelumab plus cetuximab significantly improved PFS vs. avelumab alone in advanced cSCC pts, without unexpected toxicity. Alliance A091802 supports a larger confirmatory study with combination cetuximab and PD-1:PD-(L)1 blockade."

Clinical • Metastases • P2 data • Human Immunodeficiency Virus • Immunology • Infectious Disease • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • CD4 • EGFR

A phase IIa study of the anti-PD-L1 antibody avelumab in relapsed/refractory PTCL: The AVAIL-T trial. (PubMed, Br J Haematol) - "While avelumab demonstrated durable responses in a minority, most patients progressed early. Further studies are needed to define mechanisms of response and develop predictive biomarkers to guide strategies."

IO biomarker • Journal • P2a data • Hematological Malignancies • Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • PD-1

Immune Checkpoint Inhibitor Combinations in Advanced Ovarian Cancer: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. (PubMed, Cancers (Basel)) - "ICI combination therapy improved PFS in advanced ovarian cancer, in contrast to earlier syntheses pooling monotherapy and combination regimens. The benefit was most consistent for bevacizumab-based regimens (GRADE: Moderate); the PARP inhibitor-based benefit was less robust (Low), and chemotherapy combinations offered no advantage (Very low). Subgroup differences were not statistically significant and remain exploratory; a partner-specific, biomarker-guided approach is warranted."

Checkpoint inhibition • IO biomarker • Journal • Retrospective data • Review • Oncology • Ovarian Cancer • Solid Tumor

Primary Merkel Cell Carcinoma of the Breast - A Report of an Extremely Rare Case. (PubMed, Eur J Breast Health) - "The cell proliferation marker Ki-67 was positive in over 80% of the cells. What is extremely rare in this case is the presentation of MCC of the breast as a retro areolar lesion, located behind the areola and associated with nipple discharge, without evidence of a primary cutaneous lesion."

Journal • Breast Cancer • Endocrine Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Immunology • Inflammatory Arthritis • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Rheumatoid Arthritis • Rheumatology • Skin Cancer • Solid Tumor • KRT18 • KRT20

Real-world overall survival outcomes with enfortumab vedotin–pembrolizumab versus platinum-based chemotherapy with or without avelumab maintenance in metastatic urothelial carcinoma. (ESMO 2026) - No abstract available

Clinical • Metastases • Real-world • Real-world evidence • Oncology • Solid Tumor • Urothelial Cancer

Avelumab first-line maintenance (1LM) for locally advanced or metastatic urothelial carcinoma (la/mUC) in Europe and Russia: Interim overall population and Spain subgroup analyses from the real-world AVENUE study (ESMO 2026) - No abstract available

Clinical • Metastases • Real-world • Real-world evidence • Oncology • Solid Tumor • Urothelial Cancer

A tetra-modality approach of radiotherapy post-immuno (avelumab)-chemotherapy induction, followed by maintenance avelumab or watchful waiting in muscle-invasive bladder cancer (MIBC): A multicenter phase II bladder preservation trial (TRIUMPH-B01) (ESMO 2026) - No abstract available

Clinical • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

DEPECA-1 (DEfeating PEnile CAncer 1) – A Phase II study to evaluate a first-line systemic therapy with enfortumab vedotin plus avelumab for advanced and metastatic penile carcinoma (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • Genito-urinary Cancer • Oncology • Penile Cancer • Solid Tumor

Maintenance AVElumab after SECond line platinum-based chemotherapy for metastatic urothelial carcinoma: AVESEC trial – GOIRC-02-2025. (ESMO 2026) - No abstract available

Clinical • Metastases • Oncology • Solid Tumor • Urothelial Cancer

Outcomes with first-line (1L) platinum-based chemotherapy (PBC) and avelumab 1L maintenance in locally advanced or metastatic urothelial carcinoma (la/mUC) by NECTIN4 and ERBB2 amplification status: exploratory analyses from JAVELIN Bladder 100 (ESMO 2026) - No abstract available

Clinical • Metastases • Oncology • Solid Tumor • Urothelial Cancer • HER-2 • NECTIN4

Outcomes of patients who successfully switched from chemotherapy to avelumab in the randomised DISCUS trial (ESMO 2026) - No abstract available

Clinical • Oncology

Imneskibart (AU-007) + low-dose SC IL-2 + avelumab: Phase 2 activity in CPI-refractory advanced adenocarcinoma NSCLC (ESMO 2026) - No abstract available

Metastases • P2 data • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • IL2

Real-world effectiveness and safety of first-line (1L) avelumab in patients (pts) with stage III Merkel cell carcinoma (MCC): results from a prospective German registry (MCC-TRIM) (ESMO 2026) - No abstract available

Clinical • Real-world • Real-world effectiveness • Real-world evidence • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor

A phase Ib/II study of avelumab with peptide receptor radionuclide therapy (PRRT) or radiotherapy (EBRT) in patients (pts) with metastatic Merkel cell carcinoma (mMCC): GoTHAM (ESMO 2026) - No abstract available

Clinical • Metastases • P1/2 data • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor