Bavencio (avelumab) / EMD Serono - LARVOL DELTA

Circulating tumor DNA mutational landscape and dynamics after progression on a CDK4/6 inhibitor in the PACE phase II trial for metastatic HR-positive/HER2-negative breast cancer. (PubMed, ESMO Open) - "Several mutations within genes and biological pathways are associated with CDK4/6i resistance beyond progression. Additional studies are needed to optimize treatment after resistance to CDK4/6i using genomic biomarkers."

Circulating tumor DNA • Journal • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • GATA3 • HER-2 • PIK3CA • RB1 • TP53

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

Unveiling the best immune checkpoint inhibitor-based therapy for metastatic renal cell carcinoma in the first-line setting: an updated systematic review and Bayesian network analysis. (PubMed, Ther Adv Med Oncol) - "Our findings demonstrated that combination therapies including nivolumab plus cabozantinib, pembrolizumab plus lenvatinib, toripalimab plus axitinib, nivolumab plus ipilimumab, pembrolizumab plus axitinib, and avelumab plus axitinib significantly improved OS versus sunitinib. For subgroup analysis, ICI-based combination therapies exhibited significant advantages over sunitinib for intermediate-risk or poor-risk patients, while such advantages were diminished in treating favorable-risk patients."

Checkpoint inhibition • Journal • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Subgroup analysis of the efficacy and safety of cabozantinib ± atezolizumab in patients from CONTACT-03 who received first-line treatment with immuno-oncology–based combinations (KCRS 2025) - P3 | "The current analysis evaluated progression-free survival (PFS) by blinded independent central review (BICR), overall survival (OS), objective response rate (ORR), duration of response (DOR), and safety in the subgroup of patients who received first-line standard-of-care IO–IO (ipilimumab–nivolumab) or IO–TKI (avelumab–axitinib, pembrolizumab–axitinib, or pembrolizumab–lenvatinib) combinations prior to enrolling in CONTACT-03...The data suggest that second-line cabozantinib is effective in patients with advanced RCC previously treated with contemporary first-line IO–IO or IO–TKI regimens. Safety outcomes were consistent with the overall study population."

Clinical • Immuno-oncology • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Systemic treatment of immune checkpoint inhibitor-induced psoriasis: Inference-based guidance. (PubMed, J Eur Acad Dermatol Venereol) - "Although there is no direct evidence, we support the following saPs may be used to treat ICI-Ps without an appreciable loss of ICI effectiveness. Generally, it is not necessary to interrupt ICI therapy. When available, non-steroid saPs are preferred over systemic corticosteroids for the treatment of psoriasis."

Checkpoint inhibition • Journal • Dermatology • Immunology • Oncology • Psoriasis • Rheumatology • IL12A • IL23A • TYK2

Underrecognized immune events in the emergency department among cancer patients on immune checkpoint inhibitors. (PubMed, Am J Emerg Med) - "Only 1 % of encounters carried an explicit irAE discharge diagnosis, with most visits coded using symptom-based terms, indicating that irAEs are infrequently documented at discharge. Although nearly all missed irAEs were low grade, greater awareness and standardized multidisciplinary protocols may improve the identification, management, and outcomes of patients presenting with ICI-related toxicities."

Checkpoint inhibition • Journal • Cough • Fatigue • Immunology • Musculoskeletal Pain • Myositis • Oncology • Pain • Pneumonia • Pulmonary Disease • Respiratory Diseases

ORAL IMMUNE-RELATED ADVERSE EVENTS ASSOCIATED WITH PD-1 AND PD-L1 INHIBITOR THERAPIES: A RETROSPECTIVE, SINGLE-INSTITUTION STUDY (MASCC-ISOO 2025) - "Methods We conducted a retrospective chart review including patients on PD-1 (nivolumab, pembrolizumab, cemiplimab) and PD-L1 (atezolizumab, avelumab, durvalumab) inhibitors who were treated with dexamethasone elixir, viscous lidocaine, or magic mouthwash. Four patients had oral biopsies showing ulcerated mucosa with granulation tissue, amyloidosis, and two results with lichenoid mucositis. Conclusions The results of this study may help clinicians with early identification and management of oral adverse events from PD-1/PD-L1 inhibitors and raise awareness of this important association."

Adverse events • Retrospective data • Amyloidosis • Dental Disorders • Head and Neck Cancer • Mucositis • Oncology • Solid Tumor • Stomatitis • Xerostomia

Short-term Fasting Prior to PD-1/PD-L1 Inhibitor Therapy for of Advanced or Metastatic Skin Malignancy (clinicaltrials.gov) - P1 | N=10 | Active, not recruiting | Sponsor: University of Southern California | Trial completion date: Aug 2026 ➔ Aug 2027 | Trial primary completion date: Aug 2025 ➔ Aug 2026

Checkpoint inhibition • Trial completion date • Trial primary completion date • Oncology • Skin Cancer • Solid Tumor

Focus on PD-1/PD-L1-Targeting Antibodies in Colorectal Cancer: Are There Options Beyond Dostarlimab, Nivolumab, and Pembrolizumab? A Comprehensive Review. (PubMed, Molecules) - "However, a growing number of additional PD-1/PD-L1 inhibitors, including AMP-224, atezolizumab, avelumab, camrelizumab, durvalumab, envafolimab, sintilimab, spartalizumab, tislelizumab, and toripalimab, are currently under investigation, offering new possibilities for the expansion of treatment options...Additionally, it explores key challenges such as primary and acquired resistance, limited efficacy in microsatellite-stable (MSS) CRC, and the complexities of combination strategies aimed at enhancing immunotherapeutic responses. By addressing these obstacles and highlighting prospects, this review provides insights into the evolving landscape of PD-1/PD-L1-targeted therapies in CRC and their potential to improve patient outcomes."

Journal • Review • Colorectal Cancer • Oncology • Solid Tumor • MSI

Relative Changes in Donor-Derived Cell-Free DNA as a Marker of Allograft Rejection in a Kidney Transplant Recipient with Metastatic Cancer Undergoing Immunotherapy (WTC 2025) - "Dd-cfDNA was analyzed using the AlloSeq cfDNA kit.* A 61-year-old male kidney transplant recipient diagnosed with metastatic renal cell carcinoma started treatment with avelumab in combination with axitinib. This case highlights the potential limitations of using an absolute %dd-cfDNA threshold to detect rejection in cancer patients, where tumor-derived cfDNA may interfere with interpretation. Instead, relative change value from baseline %dd-cfDNA may serve as a more reliable indicator of allograft injury, facilitating earlier intervention in transplant recipients undergoing immuno-oncology therapy."

Cell-free DNA • Clinical • IO biomarker • Metastases • Genito-urinary Cancer • Heart Failure • Oncology • Renal Cell Carcinoma • Solid Tumor • Transplant Rejection • Transplantation

CAM Assay: An Alternative, 3Rs-compliant, In Vivo Model for the Development of Anticancer Immunotherapies (EACR 2025) - "A treatment with different immunotherapy reagents is performed between EDD10 and EDD18: monoclonal Abs (bevacizumab, trastuzumab, rituximab) in 4 doses; ADC (trastuzumab emtansine) in 1 dose; ICIs (pembrolizumab, nivolumab, atezolizumab, avelumab) in 5 doses; tumor cell based vaccine (STC1010) in 3 doses; CAR-T cells & CAR-NK cells in 1 dose. Our work demonstrates that the CAM assay is suitable for testing different IO anticancer treatments. The presence of an active immune system allows a suitable characterization of the effects of immunotherapy reagents on tumor cells, the microenvironment, and the entire organism. As one part of New Approach Methodologies (NAMs), the CAM assay provides a relevant alternative, 3Rs-compliant, in vivo model for testing novel immunotherapies on a large spectrum of cancer types, as a monotherapy or as an in combination approach."

IO biomarker • Preclinical • Oncology

Real-world clinical outcomes of avelumab (A), pembrolizumab (P) or enfortumab vedotin (EV) in patients with metastatic urothelial carcinoma (mUC) with squamous differentiation (UCSD): results from the Aron-2 study. (ESMO 2025) - No abstract available

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

NCCN has published NEW NCCN Guidelines in the NCCN Guidelines Navigator. This interactive digital tool can be used to navigate the current version of the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Bladder Cancer, Version 1.2025. (NCCN)

NCCN guideline • Bladder Cancer • Urothelial Cancer

Avelumab first-line maintenance (1LM) treatment for advanced urothelial carcinoma (aUC) in France: conditional survival and long-term safety in patients (pts) treated for ≥1 or ≥2 yrs in the AVENANCE real-world study (ESMO 2025) - No abstract available

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

JAVELIN Bladder Medley phase 2 trial of avelumab + sacituzumab govitecan (Ave + SG) vs avelumab monotherapy (Ave mono) as first-line (1L) maintenance treatment for advanced urothelial carcinoma (aUC): subgroup analyses based on metastatic sites (ESMO 2025) - No abstract available

Clinical • Metastases • Monotherapy • P2 data • Oncology • Solid Tumor • Urothelial Cancer

5-year Results of Perioperative Immunochemotherapy (mDCF + Avelumab) In Locally Advanced Gastro-Esophageal Adenocarcinoma (ESMO 2025) - No abstract available

Metastases • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Oncology • Solid Tumor

A phase 2 Trial of Palbociclib and Avelumab in Advanced Solid Tumours with CDK4/6 Pathway alterations (ESMO 2025) - No abstract available

Metastases • P2 data • Oncology • Solid Tumor

The Impede phase II trial: Avelumab (A) in High-Risk Oral Potentially Malignant Disorders (OPMDs) for Prevention of Malignant Transformation (ESMO 2025) - No abstract available

P2 data • Oncology

the role of neoadjuvant Avelumab, Bevacezumab and chemotherapy in locally advanced cervical carcinoma: surgical feasibility and pathologic response (ESMO 2025) - No abstract available

Clinical • Metastases • Cervical Cancer • Oncology • Solid Tumor

Efficacy of adjuvant anti-PD-L1 avelumab by tumor infiltrating lymphocytes (TILs) for high-risk triple negative breast cancer in the phase III A-BRAVE trial. (ESMO 2025) - No abstract available

Clinical • P3 data • Tumor-infiltrating lymphocyte • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Blood-Epigenetic Biomarker Associations with Tumor Immunophenotype in Patients with Urothelial Carcinoma from JAVELIN Bladder 100. (PubMed, Cancers (Basel)) - P3 | "Our findings suggest that polygenic host factors may affect response to ICIs and support further investigation of chromatin conformation assays."

Biomarker • IO biomarker • Journal • Tumor mutational burden • Bladder Cancer • Oncology • Solid Tumor • Urothelial Cancer • TMB

A phase I study of the CSF1R inhibitor vimseltinib in combination with the PD-L1 inhibitor avelumab in patients with advanced sarcoma. (PubMed, ESMO Open) - "Vimseltinib plus avelumab was generally safe and well tolerated. This combination had minimal clinical efficacy in our population of heavily pretreated patients with sarcoma."

Journal • P1 data • Oncology • Sarcoma • Solid Tumor

Avelumab plus cetuximab in patients with unresectable stage III or IV cutaneous squamous cell carcinoma - clinical activity and safety results from AliCe, a single-arm, multicentre phase 2 DeCOG trial. (PubMed, Br J Dermatol) - "Avelumab in combination with cetuximab demonstrates encouraging clinical activity in advanced cSCC, including patients with challenging subgroups such as perianogenital primaries or those with disease that has progressed on anti-PD-1 monotherapy. This is especially true when patients are carefully selected for their ability to undergo treatment for at least 12 weeks."

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

SAMCO: Standard Chemotherapy vs Immunotherapie in 2nd Line Treatment of MSI Colorectal Mestastatic Cancer (clinicaltrials.gov) - P2 | N=132 | Completed | Sponsor: Federation Francophone de Cancerologie Digestive | Active, not recruiting ➔ Completed | Trial completion date: May 2023 ➔ Mar 2025

Trial completion • Trial completion date • Tumor mutational burden • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor • BRAF • MLH1 • MSH2 • MSH6 • MSI

Comprehensive genomic profiling by liquid biopsy in refractory metastatic colorectal cancer patients who are candidate for anti-EGFR rechallenge therapy: findings from the CAVE-2 GOIM trial. (PubMed, ESMO Open) - "LBx-based CGP might guide the appropriate use of anti-EGFR drug rechallenge or of other therapeutically actionable gene alterations in refractory mCRC."

Journal • Liquid biopsy • Tumor mutational burden • Colorectal Cancer • Oncology • Solid Tumor • KRAS • TMB