Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1739 |
| INN | Sacituzumab tirumotecan |
| Status | Approved |
| Drug code(s) | SKB264, MK-2870 |
| Brand name | 佳泰萊® |
| 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 | Stable linker |
| Ave. DAR | 7.4 |
| Conjugated/fused moiety | Topoisomerase I inhibitor, Belotecan-derived payload |
| Discovery method/technology | None |
| Target(s) | TROP-2 |
| Indications of clinical studies | Gastrointestinal cancers, Endometrial cancer, Triple-neg breast cancer, Non-small cell lung cancer, Solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved China |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | December 01, 2019 |
| Start of Phase 2 | |
| Start of Phase 3 | August 15, 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 | Klus Pharma, Kelun Pharmaceuticals |
| Licensee/Partner | Merck Sharp & Dohme |
| Comments about company or candidate | Nov 27, 2024: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. announced that the Company received marketing authorization in China from National Medical Products Administration (NMPA) for the first domestically developed trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, formerly SKB264/MK-2870) (佳 泰 萊®) for adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting). NMPA approval date is Nov 21, 2024. As of June 2024, the Sichuan Kelun-Biotech Biopharmaceutical expected to launch trastuzumab botidotin, as well as sacituzumab tirumotecan (SKB264/MK-2870, 佳泰萊®) and tagitanlimab (A167, 科泰萊®), in the China market in the second half of 2024 or the first half of 2025. https://www1.hkexnews.hk/listedco/listconews/sehk/2024/0819/2024081901322.pdf NCT06312176 Phase 3 to start in Mar 2024; NCT06312137 Phase 3 to start in Apr 2024. Jan 2024: Merck has initiated three pivotal Phase 3 clinical trials evaluating MK-2870 in which NSCLC patients are now enrolling: MK-2870-004 (NCT06074588), MK-2870-007 (NCT06170788) and MK-2870-005 (NCT06132958). NCT06305754 Phase 3 study to start in June 2023. On December 9, the official website of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China announced that Colombote’s marketing application for TROP2-ADC therapy injection SKB264 has been accepted, and the application has also been included in priority review. Indications Indicated for: Adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received at least 2 previous systemic treatments. The carbonate linker used can specifically release toxins in the acidic tumor microenvironment while exerting a bystander effect. In a prespecified interim analysis, SKB264 demonstrated a statistically significant improvement in progression-free survival compared with a control group receiving standard chemotherapy. NCT06170788 Phase 3 in NSCLC due to start in Dec 2023. CTR20231535 Phase III study evaluating SKB264 alone versus pemetrexed plus platinum in patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer who have failed EGFR-TKI therapy started in July 2023. NCT06074588 Phase 3 in NSCLC due to start in Nov 2023. NCT05870319 Phase 3 in NSCLC due to start in June 2023. May 27, 2023 Klus Pharma press release "In China, the Phase 3 registrational clinical study of SKB264 monotherapy for advanced or metastatic TNBC patients who have failed at least second-line treatment is progressing smoothly, and it is expected to become the first domestic TROP2-ADC approved for marketing." https://www.kluspharma.com/news/kelun-biotech-to-present-recent-clinical-data-for-skb264-(trop2-adc)-at-asco-2023) NCT05347134 Phase 3 in triple-neg breast cancer due to start in June 2022; described as in Phase 3 in press release dated July 26, 2022; CTR20220878 Phase 3 in triple-neg breast cancer started in Aug 2022. NCT05351788 is a Phase 2 study of SKB264 in combination with KL-A167 with or without chemotherapy with advanced or metastatic non-small cell lung cancer. NCT04152499 is a Phase I-II, First-in-Human Study of SKB264 in Patients With Locally Advanced/Metastatic Solid Tumors Who Are Refractory to Available Standard Therapies started in Feb 2020. Klus Pharma is a US subsidiary of Kelun Pharmaceuticals, which is based in China. |
| Full address of company | 101 College Rd East, 2F Princeton Forrestal Center Princeton, NJ 08540 North America United States of America https://www.kluspharma.com/contact |
SKB264 is being developed as a further optimized TROP2-targeting ADC with a proprietary cytotoxic, belotecan-derived payload and novel stable conjugation chemistry to achieve average DAR (Drug Antibody Ratio) of 7.4.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |