Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 199 |
| INN | Telisotuzumab vedotin |
| Status | Regulatory review |
| Drug code(s) | ABBV-399 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | ADC |
| Format, general category | Full length Ab conjugate |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | Valine–citrulline (Cleavable linker) |
| Ave. DAR | 3.1 |
| Conjugated/fused moiety | Tubulin inhibitor, Monomethyl auristatin E (MMAE) |
| Discovery method/technology | None |
| Target(s) | cMET |
| Indications of clinical studies | Non-small cell lung cancer, advanced solid tumors |
| 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) | March 15, 2014 |
| Start of Phase 2 | October 10, 2018 |
| Start of Phase 3 | March 25, 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 | Pierre Fabre |
| Licensee/Partner | AbbVie |
| Comments about company or candidate | Sep 27, 2024: AbbVie announced submission of a Biologics License Application to the U.S. Food and Drug Administration for accelerated approval of telisotuzumab vedotin (Teliso-V) in adult patients with previously treated, locally advanced or metastatic epidermal growth factor receptor wild type, nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression. NCT06093503 in NSCLC due to start in May 2024 was withdrawn due to strategic considerations. Phase 3 study for Non-small cell lung cancer (NCT04928846) started in Mar 2022 has primary completion date in Mar 2028. Jan 2021: AbbVie announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to investigational telisotuzumab vedotin (Teliso-V) for the treatment of patients with advanced/metastatic epidermal growth factor receptor (EGFR) wild type, nonsquamous non-small cell lung cancer (NSCLC) with high levels of c-Met overexpression whose disease has progressed on or after platinum-based therapy. NCT04928846 Phase 3 in NSCLC started in March 2022. NCT03539536 Phase 2 study in NSCLC still recruiting as of May 2021. May 2019: Results for Phase 2 NCT03574753 study presented at ASCO: ABBV-399 failed to meet the pre-specified response needed to justify continuing enrollment. Pneumonitis was an unanticipated toxicity observed in patients with SCC with previous immunotherapy exposure.Results of the phase 1b study of ABBV-399 presented at ASCO (https://ascopubs.org/doi/abs/10.1200/JCO.2019.37.15_suppl.3011). NCT03539536 Phase 2 in NSCLC started in Oct 2018; Phase 2 sponsored by Southwestern Oncology Group started in Feb 2018. Sep 2017: AbbVie and Bristol-Myers Squibb announced a clinical trial collaboration to evaluate the combination of AbbVie's investigational antibody drug conjugate ABBV-399 and Bristol-Myers Squibb's immunotherapy Opdivo (nivolumab) in c-Met overexpressing non-small cell lung cancer (NSCLC). NCT02099058 recruiting as of Aug 2017; ABBV-399 is well tolerated at a dose of 2.7 mg/kg every 21 days and has demonstrated antitumor activity in patients with c-Met+ NSCLC both as monotherapy and in combination with erlotinib. Updated data of antitumor activity and safety of ABBV-399 as monotherapy and in combination with erlotinib in c-Met+ NSCLC patients will be presented (DOI: http://dx.doi.org/10.1016/j.jtho.2016.11.449). AbbVie has collaboration with Seattle Genetics |
| Full address of company | Paris, France Europe France https://www.pierre-fabre.com/en-us |
ABBV-399 was generated with the c-Met targeting antibody, ABT-700. Wang et al. ABBV-399, a c-Met Antibody Drug Conjugate that Targets Both MET Amplified and c-Met Overexpressing Tumors, Irrespective of MET Pathway Dependence. DOI: 10.1158/1078-0432.CCR-16-1568. ABBV-399 was generated from the conjugation of vc MMAE to interchain disulfide bonds in ABT-700 after mild reduction to the sulfhydryl group (25). The average drug:antibody ratio of ABBV-399 was approximately 3.1. Antibody described in "A novel antagonist anti-cMet antibody with antitumor activities targeting both ligand-dependent and ligand-independent c-Met receptors" (DOI: 10.1002/ijc.30174)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |