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DRUG:

Bavencio (avelumab)

i
Other names: MSB0010718C, PF-06834635, MSB-0010718C, COMPOUND 2055269, MSB 0010718C, PF06834635, PF 06834635
Company:
EMD Serono
Drug class:
PD-L1 inhibitor
Related drugs:
1d
Treatment Sequencing in Advanced Urothelial Cancer. (PubMed, Drugs)
Accordingly, gemcitabine-cisplatin with nivolumab and platinum-based chemotherapy followed by maintenance avelumab remain validated evidence-based alternatives, particularly for cisplatin-eligible patients or in regions where enfortumab vedotin plus pembrolizumab is not readily accessible...Enfortumab vedotin monotherapy retains activity post-platinum and immune checkpoint inhibition, erdafitinib provides a targeted benefit in fibroblast growth factor receptor 3-altered tumors, and trastuzumab deruxtecan has emerged as a later-line option for HER2-positive disease. In parallel, circulating tumor DNA is an emerging biomarker with potential to individualize sequencing strategies, although its clinical application remains investigational. This review synthesizes current evidence and highlights practical considerations, emphasizing the need to balance therapeutic innovation with cost effectiveness, equitable access, and global applicability, while identifying critical research priorities in the post-enfortumab vedotin plus pembrolizumab era.
Review • Journal • PD(L)-1 Biomarker • IO biomarker
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HER-2 (Human epidermal growth factor receptor 2) • FGFR3 (Fibroblast growth factor receptor 3)
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HER-2 positive
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Keytruda (pembrolizumab) • Opdivo (nivolumab) • cisplatin • gemcitabine • Enhertu (fam-trastuzumab deruxtecan-nxki) • Bavencio (avelumab) • Balversa (erdafitinib) • Padcev (enfortumab vedotin-ejfv)
3d
NF1/2 mutations predict favorable benefit from immune checkpoint inhibitor-based therapies over VEGFR/mTOR inhibitors in clear cell renal cell carcinoma. (PubMed, Clin Exp Med)
This tendency was not changed by everolimus (HR = 2.66), but was abrogated slightly by sunitinib (HR = 1.59) and considerably by ICI-based therapies, including nivolumab monotherapy (HR = 1.12), atezolizumab plus bevacizumab (HR = 1.10), and avelumab plus axitinib (HR = 0.69). Overall, our findings suggest that NF1/2 mutations can serve as predictive biomarkers for favorable benefits from ICI-based treatments over VEGFR/mTOR inhibitors in advanced ccRCCs.
Journal • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker
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NF1 (Neurofibromin 1)
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EGFR mutation
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Opdivo (nivolumab) • Avastin (bevacizumab) • Tecentriq (atezolizumab) • sunitinib • everolimus • Bavencio (avelumab) • axitinib
3d
Trial of INI-4001 in Patients With Advanced Solid Tumours (clinicaltrials.gov)
P1, N=50, Recruiting, Inimmune Corporation | Not yet recruiting --> Recruiting | Trial completion date: Apr 2026 --> Mar 2027 | Trial primary completion date: Aug 2024 --> Oct 2026
Enrollment open • Trial completion date • Trial primary completion date
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Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • Bavencio (avelumab) • Libtayo (cemiplimab-rwlc)
3d
Testing the Combination of New Anti-cancer Drug Peposertib With Avelumab and Radiation Therapy for Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies (clinicaltrials.gov)
P1/2, N=103, Suspended, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Jul 2027 | Trial primary completion date: Dec 2025 --> Jul 2027
Trial completion date • Trial primary completion date • Tumor mutational burden
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Bavencio (avelumab) • peposertib (M3814)
4d
Emerging Therapeutic Synergies: Combining PD-1 Inhibitors With Poly-ADP-Ribose Polymerase (PARP) Inhibitors in the Treatment of Gynecologic Cancers. (PubMed, Cureus)
In recurrent ovarian cancer, niraparib+pembrolizumab showed modest activity with durable responses in homologous recombination-deficient (HRD) tumors; olaparib+durvalumab demonstrated high activity in gBRCA platinum-sensitive relapse, and adding bevacizumab broadened benefit in non-BRCA cohorts. In the newly diagnosed disease, rucaparib+nivolumab maintenance failed to improve PFS versus rucaparib alone. Endometrial trials (olaparib+durvalumab; talazoparib+avelumab in mismatch repair-proficient disease) showed limited activity overall, with signals restricted to biomarker-selected subgroups...PARP+PD-1/PD-L1 combinations are most compelling in ovarian cancer, particularly in BRCA/HRD tumors and, in selected settings, with the addition of bevacizumab, while frontline maintenance benefit remains unproven and endometrial activity is modest. Biomarker-guided selection, rational triplets with non-cytotoxic partners, and optimized sequencing warrant further evaluation.
Review • Journal • BRCA Biomarker • PARP Biomarker • PD(L)-1 Biomarker • IO biomarker
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HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset) • STING (stimulator of interferon response cGAMP interactor 1)
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Keytruda (pembrolizumab) • Opdivo (nivolumab) • Avastin (bevacizumab) • Lynparza (olaparib) • Imfinzi (durvalumab) • Bavencio (avelumab) • Talzenna (talazoparib) • Zejula (niraparib) • Rubraca (rucaparib)
7d
A Study to Evaluate the Safety and Pharmacokinetics of OC-001 in Patients With Locally Advanced or Metastatic Cancers (clinicaltrials.gov)
P1/2, N=73, Terminated, Ocellaris Pharma, Inc. | Trial completion date: Sep 2026 --> Nov 2025 | Active, not recruiting --> Terminated | Trial primary completion date: Mar 2026 --> Nov 2025; Business Decision
Trial completion date • Trial termination • Trial primary completion date
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • ALK (Anaplastic lymphoma kinase) • PGR (Progesterone receptor) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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HER-2 negative • ALK fusion • ALK mutation • ROS1 fusion
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Bavencio (avelumab) • OC-001
10d
AvePem: Evaluation of Clinical Outcomes, Tolerability, and Costs of Avelumab Maintenance and Pembrolizumab Second-Line Therapy in Advanced Urothelial Cancer. (clinicaltrials.gov)
P=N/A, N=35, Completed, Azienda Ospedaliera Universitaria Integrata Verona | Active, not recruiting --> Completed | N=50 --> 35 | Trial completion date: Sep 2026 --> Dec 2025
Trial completion • Enrollment change • Trial completion date • Real-world evidence
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PD-L1 (Programmed death ligand 1)
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Keytruda (pembrolizumab) • Bavencio (avelumab)
11d
DEPECA-1 - A Phase II Study to Evaluate a First-line Systemic Therapy With Enfortumab Vedotin Plus Avelumab for Advanced and Metastatic Penile Carcinoma (clinicaltrials.gov)
P2, N=25, Recruiting, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Not yet recruiting --> Recruiting
Enrollment open
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PD-L1 (Programmed death ligand 1)
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Bavencio (avelumab) • Padcev (enfortumab vedotin-ejfv)
12d
Soluble MAdCAM-1 as a biomarker in metastatic renal cell carcinoma. (PubMed, Nat Med)
We evaluated soluble MAdCAM-1 (sMAdCAM-1) as a prognostic biomarker in 1,051 patients from three cohorts: JAVELIN Renal 101 (avelumab plus axitinib versus sunitinib), SURF (sunitinib) and NIVOREN (nivolumab after tyrosine kinase inhibitors). Notably, low sMAdCAM-1 levels were associated with an immunosuppressive gut microbiota profile dominated by Enterocloster species. Therefore, sMAdCAM-1 deserves further investigations as a biomarker-guided tool for microbiota-targeted interventions.
Journal • PD(L)-1 Biomarker • IO biomarker
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IL17A (Interleukin 17A)
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Opdivo (nivolumab) • sunitinib • Bavencio (avelumab) • axitinib
15d
Urothelial Carcinoma With a Novel MET Exon 14 Skipping Alteration. (PubMed, Cancer Diagn Progn)
He received carboplatin-gemcitabine followed by maintenance avelumab. This case broadens the spectrum of MET exon 14 skipping events in UC by documenting a novel intronic c.2942-22_2942-19delCTTT alteration in plasmacytoid carcinoma. It underscores the importance of routine genomic profiling in advanced and histologically rare UC to uncover targetable alterations and supports consideration of MET-directed therapies or enrollment in tumor-agnostic trials for selected patients, while highlighting the need for further functional and clinical validation.
Journal • PD(L)-1 Biomarker
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MET (MET proto-oncogene, receptor tyrosine kinase)
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MET exon 14 mutation
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carboplatin • gemcitabine • Bavencio (avelumab)
21d
Spatial Proteomics of Tertiary Lymphoid Structures Reveals Correlation with Immunotherapy Response in Merkel Cell Carcinoma. (PubMed, Br J Dermatol)
This study demonstrated a significant positive correlation between the number of TLS and ICI response in MCC. Additionally, our results suggest that the immune composition and spatial configuration within TLS may be important determinants of ICI efficacy.
Journal
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CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CD4 (CD4 Molecule)
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Bavencio (avelumab)
26d
[89Zr]Zr-DFO-avelumab accumulation in resectable non-small cell lung carcinoma indicates a suppressive tumor microenvironment amendable to neoadjuvant avelumab treatment. (PubMed, Immunother Adv)
[89Zr]Zr-DFO-avelumab PET imaging is a safe and feasible approach in early-stage NSCLC. Higher [89Zr]Zr-DFO-avelumab tumor-accumulation at baseline strongly correlates with features of a suppressive tumor immune environment and response to neoadjuvant avelumab.
Journal • PD(L)-1 Biomarker • IO biomarker
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PD-L1 (Programmed death ligand 1) • CLEC4C (C-Type Lectin Domain Family 4 Member C)
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PD-L1 expression
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Bavencio (avelumab)