Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 633 |
| INN | Bemarituzumab |
| Status | Clinical |
| Drug code(s) | FPA144 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | FGFR2b |
| Indications of clinical studies | Gastric and gastroesophageal junction adenocarcinoma, Solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | November 01, 2014 |
| Start of Phase 2 | |
| Start of Phase 3 | September 28, 2018 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Amgen |
| Licensee/Partner | Zai Lab |
| Comments about company or candidate | Listed as in Amgen pipeline dated Oct 30 2024 as Phase 3 for gastric cancers https://www.amgenpipeline.com/-/media/Themes/Amgen/amgenpipeline-com/amgenpipeline-com/PDF/amgen-pipeline-chart.pdf Phase 3 Gastric cancer/gastroesophageal junction adenocarcinoma: NCT05052801 is active non recruiting, NCT05111626 is recruiting as of November 2024. Phase 3 Gastric cancer/gastroesophageal junction adenocarcinoma (NCT05111626, NCT05052801) studies are recruiting as of May 25, 2023. Aug 2022: Zai Lab plans to initiate a registrational study of bemarituzumab in first-line advanced gastric and GEJ cancer in Greater China in the fourth quarter of 2022. Sep 2021: Zai Lab Limited an innovative commercial-stage biopharmaceutical company, announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation for investigational bemarituzumab (FPA144), for first-line treatment for patients with FGFR2b overexpressing and human epidermal growth factor receptor (HER2)-negative metastatic and locally advanced gastric and GEJ cancers in combination with modified FOLFOX6 (fluoropyrimidine, leucovorin, and oxaliplatin). Amgen acquired Five Prime Therapeutics. April 19, 2021: Amgen announced that the FDA granted Breakthrough Therapy Designation for investigational bemarituzumab as first-line treatment for patients with fibroblast growth factor receptor 2b (FGFR2b) overexpressing and human epidermal growth factor receptor 2 (HER2)-negative metastatic and locally advanced gastric and gastroesophageal (GEJ) adenocarcinoma in combination with modified FOLFOX6 (fluoropyrimidine, leucovorin, and oxaliplatin), based on an FDA-approved companion diagnostic assay showing at least 10% of tumor cells overexpressing FGFR2b. On March 4, 2021, Amgen and Five Prime Therapeutics announced an agreement under which Amgen will acquire Five Prime Therapeutics. Five Prime’s lead asset, bemarituzumab, is a first-in-class, Phase 3-ready antibody with positive data from a randomized, placebo-controlled Phase 2 study in frontline advanced gastric or gastroesophageal junction cancer. Aug 2019: Enrollment in the NCT03694522 FIGHT trial continues ahead of projections due to FGFR2b biomarker prevalence that has remained steady at more than 30%, strong clinical trial execution, and continued support and enthusiasm from clinical investigators. The company plans to conduct an early futility analysis for the FIGHT trial during the first half of 2020. The purpose of the futility analysis is to ensure the trial is adequately powered to detect an overall survival benefit at full enrollment. October 1, 2018 I Five Prime Therapeutics, Inc. (Nasdaq: FPRX), a biotechnology company discovering and developing innovative immuno-oncology protein therapeutics, and Zai Lab Limited (Nasdaq: ZLAB), a Shanghai-based innovative biopharmaceutical company, today announced dosing of the first patient in the Phase 3 FIGHT pivotal trial of bemarituzumab (FPA144), an isoform-selective FGF receptor 2b (FGFR2b) antibody, in combination with chemotherapy in patients with previously untreated, advanced gastric cancer (GC) or gastroesophageal junction (GEJ) cancer. The first patient was dosed at a participating investigative site in China on Sept. 28. NCT02318329 Phase 1 study started in Nov 2014; two Phase 1 studies recruiting as of March 2018. In July 2016, the U.S. Food and Drug Administration (FDA) granted bemarituzumab (FPA144) Orphan Drug Designation for the treatment of gastric cancer, including cancer of the gastroesophageal junction. |
| Full address of company | Thousand Oaks, California, United States North America United States of America https://www.amgen.com/ |
POTELLIGENT-derived, ADCC enhanced; antibody is engineered to recruit NK cells into the tumor microenvironment and kill cancer cells by antibody-dependent cell-mediated cytotoxicity
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |