Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1717 |
| INN | Tarlatamab |
| Status | Approved |
| Drug code(s) | AMG 757 |
| Brand name | IMDELLTRA |
| mAb sequence source | mAb - source TBD |
| General Molecular Category | Bispecific |
| Format, general category | Fragment-Fc |
| Format details | scFv-scFv-scFc |
| Isotype (Fc) | TBD |
| Light chain isotype | TBD |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | DLL3, CD3 |
| Indications of clinical studies | Small-cell lung cancer, neuroendocrine prostate cancer |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved US, Canada |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | December 16, 2017 |
| Start of Phase 2 | December 01, 2021 |
| Start of Phase 3 | June 07, 2023 |
| Date BLA/NDA submitted to FDA | October 12, 2023 |
| Year of first approval (global) | 2024 |
| Date of first US approval | May 16, 2024 |
| INN, US product name | Tarlatamab, tarlatamab-dlle |
| US or EU approved indications | Treatment of adult patients with extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy |
| Company | Amgen |
| Licensee/Partner | BeiGene |
| Comments about company or candidate | May 16, 2024: Amgen announced that the U.S. Food and Drug Administration (FDA) has approved IMDELLTRA™ (tarlatamab-dlle) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. IMDELLTRA has received accelerated approval based on the encouraging response rate and duration of response (DoR) observed in clinical studies. Dec. 13, 2023: Amgen announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the Company's Biologics License Application (BLA) for tarlatamab. Oct 2023: Positive results of NCT05060016 published. Tarlatamab, administered as a 10-mg dose every 2 weeks, showed antitumor activity with durable objective responses and promising survival outcomes in patients with previously treated small-cell lung cancer. DOI: 10.1056/NEJMoa2307980 Phase 2 (potentially pivotal) for Small cell lung cancer (NCT05060016) is active not recruiting as of June 1, 2023; phase 3 for Small cell lung cancer (NCT05740566) is recruiting as of June 7, 2023. According to 2023 first quarter financial results (April 27, 2023), potentially registrational Phase 2 study "Data readout is anticipated in H2 2023" https://www.amgen.com/newsroom/press-releases/2023/04/amgen-reports-first-quarter-financial-results NCT05740566 Phase 3 in small cell lung cancer started in June 2023. DeLLphi-301 is a potentially registrational Phase 2 study of tarlatamab for the treatment of relapsed/refractory SCLC after two or more prior lines of treatment, continues to enroll patients. NCT05060016 Phase 2 study started in Dec 2021. November 9, 2020 I Amgen announced the first presentation of AMG 757 Phase 1 clinical safety and efficacy data in relapsed or refractory small cell lung cancer (SCLC). AMG 757 is an investigational half-life extended (HLE) bispecific T cell engager (BiTE®) molecule targeting delta-like ligand 3 (DLL3). The DLL3 protein is overexpressed on the cell surface of SCLC tumors and minimally expressed in normal tissues.1 Data will be featured during a live oral presentation on Nov. 12 at the Society for Immunotherapy of Cancer's (SITC) 35th Annual Meeting being held virtually. Listed in Amgen pipeline dated July 29, 2019. NCT03319940 Phase 1 study in SCLC started in Dec 2017 still recruiting as of Aug 2019 |
| Full address of company | Thousand Oaks, California, United States North America United States of America https://www.amgen.com/ |
N297G; R292C, V302C mutations AMG 757 is an extended half-life anti-DLL3 x anti-CD3 BiTE® (bispecific T cell engager) antibody construct. immunoglobulin scFv-scFv-scFc, anti-[Homo sapiens DLL3 (delta-like ligand 3)] and anti-[Homo sapiens CD3E (CD3 epsilon, Leu-4)], monoclonal antibody single chain (scFv)2-scFc, bispecific
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |