Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 109 |
| INN | Avelumab |
| Status | Approved |
| Drug code(s) | MSB0010718C |
| Brand name | Bavencio |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | lambda |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Phage display-derived (Dyax library) |
| Target(s) | PD-L1 |
| Indications of clinical studies | Gastric cancer, ovarian cancer, non-small cell lung cancer, Merckel cell carcinoma, Solid tumors, renal cell cancer |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | January 15, 2013 |
| Start of Phase 2 | July 15, 2014 |
| Start of Phase 3 | March 15, 2015 |
| Date BLA/NDA submitted to FDA | September 23, 2016 |
| Year of first approval (global) | 2017 |
| Date of first US approval | March 23, 2017 |
| INN, US product name | Avelumab |
| US or EU approved indications | Merkel cell carcinoma, Bladder cancer; Oct 2019: European Commission approved BAVENCIO® (avelumab) in combination with axitinib for the first-line treatment of adult patients with advanced renal cell carcinoma; FDA approval for maintenance treatment for patients who have locally advanced or metastatic bladder cancer whose disease didn't progress after undergoing first-line platinum-containing chemotherapy |
| Company | EMD Serono |
| Licensee/Partner | None |
| Comments about company or candidate | Feb 2018: Avelumab (Bavencio) missed the primary endpoint of improving overall survival (OS) in pretreated patients with non–small cell lung cancer (NSCLC), according to findings from the phase III JAVELIN Lung 200 Trial. Approved March 23, 2017 in US; approved in EU Sep 18, 2017 Priority review in US. US orphan designation for merkel cell carcinoma; positive opinion for orphan desig. in EU. Nov 2015: Avelumab has received breakthrough therapy and fast track status from the FDA as a treatment for metastatic Merkel cell carcinoma. NCT02395172 Phase 3 study recruiting as of April 2015. Two Phase 1 studies recruiting as of Feb 2014; NCT02155647 Phase 2 study started in July 2014 |
| Full address of company | One Technology Place, Rockland, MA 02370 North America United States of America https://www.emdserono.com/us-en/company/contact-us.html |
Immune checkpoint target. three approved PD-L1 antibodies have differentiated FcγR-binding properties; Atezolizumab and durvalumab are designed to eliminate FcγR-binding and effector functions, while avelumab retains intact Fc functions.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |