Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1844 |
| INN | Patritumab |
| Status | Terminated |
| Drug code(s) | AMG 888, U3-1287 |
| Brand name | None |
| 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 | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Transgenic mouse |
| Target(s) | HER3 |
| Indications of clinical studies | Solid tumors, Non-small Cell Lung Cancer, Breast Cancer, head and neck cancer |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Terminated at Phase 3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | May 01, 2008 |
| Start of Phase 2 | |
| Start of Phase 3 | March 15, 2014 |
| 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 | Daiichi Sankyo Co. Ltd. |
| Licensee/Partner | Amgen |
| Comments about company or candidate | Development appears to be focused on ADC version, U3-1402. Jan 2019: Daiichi Sankyo terminates a phase II trial in Head and neck cancer (Combination therapy, First-line therapy, Metastatic disease) in Hungary, Belgium, France, Poland, Romania, United Kingdom, Germany (IV) (NCT02633800). May 2016: two-part phase 3 HER3-Lung study of patritumab will not proceed into the second part. This decision followed the recommendation of an independent data monitoring committee (DMC) that concluded that the first part of the study (Part A) did not meet the pre-defined efficacy criteria required to proceed with Part B of the study. The phase 2 study evaluating patritumab in previously-untreated recurrent or metastatic head and neck cancer is ongoing and enrolling patients IND filed in May 2008. Phase 3 study in Locally Advanced or Metastatic Non-Small Cell Lung Cancer. Patritumab was researched by collaboration of former U3 Pharma and former Abgenix (current Amgen) in Germany. Clinically meaningful efficacy were not observed in NSCLC, breast cancer and H&N cancer. (Daiichi Sankyo presentation, Sep 2018) |
| Full address of company | Nihonbashi Building, 3-14-10, Nihonbashi, Chuo-ku, Tokyo 103-8234, Japan Asia Japan https://www.daiichisankyo.com/about_us/corporate_info/group/ |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |