Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1743 |
| INN | Patritumab deruxtecan |
| Status | Regulatory review |
| Drug code(s) | U3-1402 |
| Brand name | (Pending) |
| mAb sequence source | mAb human |
| General Molecular Category | ADC |
| Format, general category | Full length Ab conjugate |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | Glycine-Glycine-Phenylalanine-Glycine (GGFG; Cleavable linker)) |
| Ave. DAR | 8 |
| Conjugated/fused moiety | Topoisomerase I inhibitor, DXd/DX-8951 (MAAA-1181a) |
| Discovery method/technology | Transgenic mouse |
| Target(s) | HER3 |
| Indications of clinical studies | Colorectal cancer, Breast cancer, non-small cell lung cancer |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Regulatory review US |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | November 15, 2016 |
| Start of Phase 2 | September 14, 2020 |
| Start of Phase 3 | April 13, 2022 |
| 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 | Merck |
| Comments about company or candidate | June 26, 2024 I The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) seeking accelerated approval of Daiichi Sankyo and Merck’s (known as MSD outside of the United States and Canada) (NYSE: MRK) patritumab deruxtecan (HER3-DXd) for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies.The CRL results from findings pertaining to an inspection of a third-party manufacturing facility. The CRL did not identify any issues with the efficacy or safety data submitted. December 22, 2023 – Daiichi Sankyo and Merck announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to the Biologics License Application (BLA) for patritumab deruxtecan (HER3-DXd) for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies. Oct 2023: The submission of a biologics license application (BLA) in the U.S. is planned by the end of March 2024 for patritumab deruxtecan, which is based on data from the HERTHENA-Lung01 phase 2 trial recently presented at the IASLC 2023 World Conference on Lung Cancer and simultaneously published in the Journal of Clinical Oncology. October 19, 2023 I Daiichi Sankyo and Merck have entered into a global development and commercialization agreement for three of Daiichi Sankyo’s DXd antibody drug conjugate (ADC) candidates: patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd). NCT05338970 Phase 3 study of patritumab deruxtecan in NSCLC started in May 2022 recruiting as of last update in Mar 2023. Patritumab deruxtecan was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration in December 2021 for the treatment of patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) with disease progression on or after treatment with a third-generation tyrosine kinase inhibitor (TKI) and platinum-based therapies. Feb 3, 2021: Daiichi Sankyo Company, Limited announced that the first patient has been dosed in HERTHENA-Lung01 (NCT04619004), a phase 2 study evaluating patritumab deruxtecan, a HER3 directed DXd antibody drug conjugate (ADC), in patients with epidermal growth factor receptor (EGFR)-mutated metastatic or locally advanced non-small cell lung cancer (NSCLC) previously treated with a tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy. NCT04699630 Phase 2 in breast cancer due to start in Feb 2021. NCT04479436 Phase 2 in colorectal cancer started in Sep, 2020. September 10, 2019 I Daiichi Sankyo Company, Limited announced the presentation of updated phase 1 data for U3-1402, an investigational HER3 targeting antibody drug conjugate (ADC), in 30 patients with metastatic EGFR mutated, TKI resistant non-small cell lung cancer (NSCLC). The late-breaking data were featured today in a Mini Oral Session at the IASLC 2019 World Conference on Lung Cancer (#WCLC19) in Barcelona, Spain (#MA21.06, Abstract #1720). As of Aug 2019, NCT03260491 Phase 1 study in NSCLC (started in Oct 2017) is recruiting and NCT02980341 Phase 1/2 study in breast cancer (started in Nov 2016) is recruiting. Listed in Daiichi pipeline as Phase 1 for breast cancer and NSCLC; updated as of July 2019. NCT02980341 Phase 1/2 in breast cancer, NCT03260491 Phase 1 in NSCLC recruiting as of Sep 2018. JapIC clinical trial registry CTI-163401. |
| Full address of company | Chuo City, Tokyo, Japan Asia Japan https://www.daiichisankyo.com/ |
Patritumab deruxtecan is composed of an anti-HER3 antibody attached by a peptide linker to a novel topoisomerase I inhibitor (DXd) payload, utilizing Daiichi Sankyo's proprietary payload and linker-payload technologies. U3-1402 achieves a Drug-Antibody Ratio (DAR) near 8
| Anticipated events | Anticipate approval - CRL sent in June 2024 |
| Factor(s) contributing to discontinuation | None |