Avelumab
- Generic Name
- Avelumab
- Brand Names
- Bavencio
- Drug Type
- Biotech
- CAS Number
- 1537032-82-8
- Unique Ingredient Identifier
- KXG2PJ551I
- Background
Avelumab is a human IgG1 lambda monoclonal antibody that binds programmed cell death ligand-1 (PD-L1) to block its interaction with its receptors found on T cells and antigen-presenting cells. Avelumab was first approved by the FDA on March 23, 2017. On September 18 and December 18 of the same year, it was also granted approval by EMA and Health Canada, respectively. It is used in the treatment of Merkel cell carcinoma, metastatic urothelial carcinoma, or renal cell carcinoma.
- Indication
Avelumab is indicated for the treatment of adults with metastatic Merkel cell carcinoma (MCC). In the US, it is also used in patients 12 years and older.
It is also indicated as the maintenance treatment in patients with locally advanced or metastatic urothelial carcinoma (UC), which has not progressed with first-line platinum-containing chemotherapy. In the US, avelumab is also indicated to treat locally advanced or metastatic UC with disease progression during or after platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Avelumab is indicated, in combination with axitinib, for the first-line treatment of advanced renal cell carcinoma (RCC).
- Associated Conditions
- Advanced Renal Cell Carcinoma, Metastatic Urothelial Cancer, Locally advanced Urothelial Carcinoma, Metastatic Merkel Cell Carcinoma (MCC)
- Associated Therapies
- First Line Chemotherapy, Maintenance therapy
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• Phase 1a trial results showed disease control in 64% of evaluable patients with platinum-resistant ovarian cancer, with a 20% overall response rate at the highest dose level and median overall survival of 190 days.
• The Helsinki-based company is expanding its U.S. clinical footprint with multiple new trial sites planned for 2025, while also pursuing additional Phase 1b studies in melanoma and other indications.
AbTherx Partners with Rondo and Spice Biotechnologies to Accelerate Bispecific Antibody Development for Cancer Immunotherapy
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• Spice Bio's founder, Alan J. Korman, previously collaborated with AbTherx cofounders to develop groundbreaking immune checkpoint inhibitors YERVOY® and OPDIVO®, highlighting the potential significance of these new partnerships.
Africa Launches Continental Medicine Approval System with First Five Products
• Africa has approved five human medicinal products through a new continental regulatory process, marking a historic milestone to improve access to safe and effective medicines across the continent.
• The approved products include Easy Six Vaccine for children, Gardasil 9 for HPV prevention, and cancer treatments Bavencio and Keytruda, all listed in a new transparent digital registry called the Green Book.
• This initiative, led by the African Medicines Regulatory Harmonisation (AMRH), aims to streamline approvals, combat counterfeit drugs, and serves as a foundation for the upcoming African Medicines Agency (AMA).
Vaximm's VXM01-Avelumab Combination Shows Promise in Phase 2a Glioblastoma Trial
• Vaximm AG's Phase 2a trial demonstrates that VXM01, an oral anti-VEGFR-2 vaccine, combined with avelumab shows a favorable safety profile in recurrent glioblastoma patients, with no serious adverse events attributed to VXM01.
• The combination therapy achieved a 12.0% objective response rate in non-resected patients and a median overall survival of 11.1 months, exceeding typical survival rates for recurrent glioblastoma patients.
• Exploratory biomarker investigations identified potential predictive markers of VXM01-mediated tumor response, supporting further investigation of this immunotherapy approach for this aggressive brain cancer.
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• The metastatic colorectal cancer segment shows particular promise with 150+ companies advancing 180+ pipeline therapies, including innovative treatments targeting specific mutations and immune pathways.
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• Vaccinex plans to continue developing pepinemab for both Alzheimer's disease and oncology indications through partnerships, including ongoing collaborations with MSD and Merck KGaA for cancer trials.
Avelumab Maintenance Shows Consistent Survival Benefits in Advanced Urothelial Cancer Patients With and Without Diabetes
• Phase 3 JAVELIN Bladder 100 trial demonstrates avelumab maintenance therapy significantly extended overall survival to 20.8 months versus 14.5 months with best supportive care alone in diabetic patients with advanced urothelial carcinoma.
• The treatment showed similar efficacy in non-diabetic patients, with median overall survival of 24.7 months compared to 15.8 months with best supportive care, confirming benefit regardless of diabetes status.
• Safety profile remained consistent across both patient groups, with manageable immune-related adverse events occurring in approximately 32% of avelumab-treated patients.
Adverse Events Linked to Better Survival Outcomes in Enfortumab Vedotin Treatment for Urothelial Cancer
• New research reveals patients experiencing neuropathy, skin rash, or hyperglycemia while taking Enfortumab Vedotin showed significantly improved progression-free survival in metastatic urothelial carcinoma treatment.
• Study of 83 patients demonstrated extended progression-free survival of up to 15.9 months in those experiencing specific adverse events, compared to 4.5 months in those without these effects.
• Findings were presented at the 2025 ASCO Genitourinary Cancers Symposium, following the FDA's recent approval of Enfortumab Vedotin with Pembrolizumab for advanced urothelial cancer.
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• The combination therapy showed significant progression-free survival benefit of 12.5 months compared to 6.3 months with chemotherapy, representing a 52% reduction in disease progression risk.
• Extended 12-month follow-up data confirms sustained efficacy across all patient subgroups, including both cisplatin eligible and ineligible patients, with no new safety concerns identified.
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• Despite Keytruda's established success in metastatic HNSCC, this setback highlights the ongoing challenges in treating early-stage head and neck cancer with immunotherapy.
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• The FDA is reviewing the application under the Real-Time Oncology Review (RTOR) program to expedite potential approval.
Adjuvant Pembrolizumab Maintains Survival Benefit in Renal Cell Carcinoma
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• ODAC will discuss Tecentriq with Abraxane for advanced triple-negative breast cancer, focusing on alternative confirmatory studies after the Impassion131 trial failure.
• Keytruda and Tecentriq's first-line treatment status for urothelial carcinoma is under review, considering the approval of Bavencio as a first-line maintenance therapy.
• The committee will also assess Keytruda for gastric cancer and Keytruda/Opdivo for hepatocellular carcinoma, examining if the initial benefits have been confirmed.
Real-World AVION Study Affirms Avelumab Plus Axitinib Efficacy in Advanced Renal Cell Carcinoma
• The AVION study demonstrated that first-line avelumab plus axitinib is effective and safe for advanced renal cell carcinoma (RCC) in real-world settings.
• The 12-month overall survival rate was 82.7% among patients receiving the combination therapy, aligning with results from prior clinical trials.
• Common treatment-related adverse events included diarrhea, fatigue, and hypertension, with manageable safety profiles and stable health-related quality of life.
• These findings support the use of avelumab plus axitinib as a frontline treatment option for advanced RCC, reinforcing its clinical benefit.
Keytruda Approved in China for Early-Stage NSCLC Treatment
• Keytruda gains approval in China for resectable stage II, IIIA, or IIIB NSCLC in combination with platinum-containing chemotherapy.
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• This marks Keytruda's fourth indication for NSCLC in China, extending its use to earlier stages of the disease.
• The treatment involves neoadjuvant Keytruda plus chemotherapy, followed by adjuvant Keytruda monotherapy post-surgery.
FDA Grants Priority Review to Replimune's RP1 Plus Nivolumab for Advanced Melanoma
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• RP1 is a novel oncolytic immunotherapy based on a modified herpes simplex virus, designed to maximize tumor killing and stimulate an anti-tumor immune response.
• The ongoing Phase 3 IGNYTE-3 trial is assessing the combination in patients who have progressed on or are ineligible for anti-CTLA-4 therapies.
Immutep's Efti Shows Promise in Lung and Head & Neck Cancers, Advances Autoimmune Program
• Immutep's eftilagimod alfa (efti) in combination with pembrolizumab (KEYTRUDA®) receives positive FDA feedback for a Phase III trial in first-line non-small cell lung cancer (NSCLC).
• Phase IIb trial (TACTI-003) results show efti plus KEYTRUDA® demonstrates efficacy and favorable safety in first-line head and neck cancer, particularly in PD-L1 negative tumors.
• Immutep doses first participant in Phase I trial of IMP761, a novel LAG-3 agonist antibody, targeting autoimmune diseases, marking a significant milestone.
• The company's strong financial position, with A$172.3 million, extends its cash reach to the end of CY2026, supporting ongoing clinical programs.
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