Avelumab: brief Review of its R&D progress and the clinical result in 2023 ESMO

On October 20, 2023, “Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (aUC): Long-term outcomes from the JAVELIN Bladder 100 trial in older patients (pts) ”was reported at the ESMO Congress.

Avelumab's R&D Progress

Avelumab is a monoclonal antibody drug that targets PDL1, a protein involved in regulating the immune system. It has been developed by Merck Serono SA and has received approval for use in various therapeutic areas. These areas include neoplasms (abnormal growth of cells), digestive system disorders, immune system diseases, hemic and lymphatic diseases, urogenital diseases, respiratory diseases, and infectious diseases. 

According to the Patsnap Synapse, the highest phase of development for Avelumab globally is approved. In China, the highest phase is phase 3. And the clinical trial distributions for Avelumab are primarily in the United States, China, and United Kingdom. The key indication is Neoplasms.

Detailed Clinical Result of Avelumab

The randomized, parallel assignment, open-labeled clinical trial (NCT02603432) was aimed to evacuate the long-term efficacy and safety outcomes in subgroups based on older age (≥65 years). 

In this study, eligible pts with locally advanced or metastatic UC without progression following 4 to 6 cycles of 1L platinum-based chemotherapy were randomized 1:1 to receive avelumab + BSC (n=350) or BSC alone (n=350). The primary endpoint was OS; secondary endpoints included PFS and safety. For this post hoc analysis, subgroups aged ≥65 to <75 years, ≥75 years, and ≥80 years were analyzed. Pts aged <65 years were not included in this analysis.

The result showed that at data cutoff (June 4, 2021), median follow-up in both arms was ≥38 months. In the avelumab + BSC and BSC alone arms, age was ≥65 to <75 years in 136 and 163 pts, ≥75 years in 85 and 80 pts, and ≥80 years in 28 and 27 pts, respectively. Across all subgroups, OS and PFS were prolonged with avelumab + BSC vs BSC alone (Table). The table also shows incidence of any-grade and grade ≥3 treatment-related adverse events (TRAEs) in the subgroups.

It can be concluded that Long-term outcomes from JAVELIN Bladder 100 confirm prolonged OS and PFS with avelumab + BSC vs BSC alone in older pts. Long-term safety of avelumab 1L maintenance was similar across subgroups, confirming its tolerability. These findings provide further support for avelumab 1L maintenance as standard of care in pts with aUC without progression following 1L platinum-based chemotherapy, including pts over 65 years old.

How to Easily View the Clinical Results Using Synapse Database?

If you want to know the other clinical results of popular conferences, please lick on the “Clinical Results” on the homepage of Patsnap Synapse, which provides multi-dimensional screening and filtering of drugs, indications, targets, companies, result evaluation, release date, popular conferences, etc. to help you quickly locate the data you need. 

Select the clinical meeting you are interested in, such as ESMO. In the results, you can quickly locate the data you want to view by indication, phase and drug name. 

A single result clearly shows important information such as registration number, phase, indication, Sponsor/Collaborator, biomarker, Trial number, dosing regimen and more. 

If you would like to view more information about this result, you can go to the result detail page by clicking on the title. 

Above the headings, we provide the original source of the outcome data. The basic information is supplemented with more information beyond the list, such as company, study. design, etc. 

In the important Outcome Measures section, we provide both list and flowchart forms, which are convenient for you to overview the comparison group information and core indicator data. 

Finally, if you need to download these results, you can conveniently check the check boxes on the left side of the list, or directly click the "Export" button to download the data for personalized analysis and file sharing.

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