Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 688 |
| INN | Cobolimab |
| Status | Clinical |
| Drug code(s) | GSK4069889, TSR-022 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | TIM3 |
| Indications of clinical studies | Non-small cell lung cancer, Solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 2/3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | July 15, 2016 |
| Start of Phase 2 | October 15, 2018 |
| Start of Phase 3 | December 15, 2020 |
| 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 | GSK |
| Licensee/Partner | None |
| Comments about company or candidate | GSK Q3 2023 results presentation lists cobolimab COSTAR 2L NSCLC study as a pipeline catalyst in H2 2024. https://www.gsk.com/media/10668/q3-2023-results-slides.pdf In GSK pipeline cobolimab is reported in Phase 3, on clinicaltrials.gov NCT04655976 is reported as phase 2/3 and recruiting as of November 18, 2022. Oct 2022: GSK is advancing both arms of the COSTAR Lung trial into phase III. The decision follows the recommendation of the Independent Data Monitoring Committee, given that the trial met its pre-specified expansion criteria per protocol. The COSTAR Lung phase III trial is a randomized, open label 3-arm trial comparing cobolimab, an investigational selective anti–TIM-3 monoclonal antibody, plus dostarlimab plus docetaxel to dostarlimab plus docetaxel to docetaxel alone in patients with advanced NSCLC who have progressed on prior anti-PD-L1 therapy and chemotherapy. NCT04655976 Phase 2/3 in NSCLC recruiting as of Dec 2020. Listed as Phase 2 in May 1, 2019 GSK Q1 2019 results document. NCT03680508 Phase 2 with sponsor U of Hawaii posted in Sep 2018 but not updated since. NCT02817633 Phase 1 study started in July 2016 still recruiting as of July 2018 |
| Full address of company | 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom Europe United Kingdom https://www.gsk.com/en-gb/contact-us/ |
Immune checkpoint target. TSR-022 is an anti-TIM-3 (T cell immunoglobulin and mucin containing protein-3) humanized monoclonal IgG4 antibody
| Anticipated events | BLA, MAA in NSCLC possible in 2025 (https://www.gsk.com/media/11102/q1-2024-pipeline-assets-and-clinical-trials-report.pdf) |
| Factor(s) contributing to discontinuation | None |