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Sacituzumab tirumotecan is a TROP2 antibody-drug conjugate approved for specific advanced breast- and lung-cancer settings in China. It remains investigational in the United States.
Kelun-Biotech reports four Chinese approvals: previously treated advanced TNBC in November 2024; EGFR-mutated nonsquamous NSCLC after EGFR-TKI and platinum chemotherapy in March 2025; progression after EGFR-TKI therapy in October 2025; and HR-positive/HER2-negative advanced breast cancer after endocrine therapy and at least one advanced-disease chemotherapy line in February 2026. These are sponsor-reported NMPA decisions, not independently reviewed Chinese labels. Merck lists the molecule as investigational in its US development pipeline. The published OptiTROP-Breast01 phase 3 trial randomized 263 previously treated metastatic TNBC patients: PFS was 6.7 versus 2.5 months, HR 0.32 (95% CI 0.24 to 0.44), and interim OS HR 0.53 (95% CI 0.36 to 0.78). This is neither FDA approval nor evidence of postoperative benefit or superiority over another ADC.
Sac-TMT carries T030, a belotecan-derived TOP1 inhibitor; belotecan shown.
Anti-TROP2 IgG1 with a stable, irreversibly-conjugated linker and a belotecan-derived TOP1 payload with reported lower efflux-pump susceptibility. Connects to TROP2.
1.Antibody binds TROP2 on the tumour cell surface
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
Source: www.frontiersin.org/journals/oncology-reviews/articles/10.3389/or.2026.1781533/full. Doses are for orientation; the current label governs.
| Date | Deal | Type | Upfront | Total | Source |
|---|---|---|---|---|---|
| 2022-05 | Sichuan Kelun-Biotech to Merck & Co. (MSD) Sacituzumab tirumotecan (SKB264, MK-2870), TROP2 ADC | Licence | $47m | up to $1.4bn | source |
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Adults with unresectable locally advanced or metastatic TNBC after at least two systemic therapies, including at least one for advanced or metastatic disease; date is the announcement month, not an independently verified authorization day source
Breakthrough Therapy designation, EGFR-mutant NSCLC after TKI source
Adults with EGFR-mutated locally advanced or metastatic nonsquamous NSCLC after EGFR-TKI therapy and platinum-based chemotherapy; date is the announcement month, not an independently verified authorization day source
Adults with EGFR-mutated locally advanced or metastatic nonsquamous NSCLC progressing after EGFR-TKI therapy; date is the announcement month, not an independently verified authorization day source
Adults with unresectable or metastatic HR-positive/HER2-negative breast cancer after endocrine therapy and at least one chemotherapy line in advanced disease; date is the announcement month, not an independently verified authorization day source
Commissioner's National Priority Voucher (CNPV) awarded source
| Region | Year | Indication |
|---|---|---|
| China | 2024 | Adults with unresectable locally advanced or metastatic TNBC after at least two systemic therapies, including at least one for advanced or metastatic disease · Sponsor-reported NMPA approval: https://www.prnewswire.com/news-releases/kelun-biotechs-trop2-adc-sacituzumab-tirumotecan-sac-tmt-approved-for-marketing-by-nmpa-of-china-for-2l-advanced-or-metastatic-tnbc-302317233.html |
| China | 2025 | Adults with EGFR-mutated locally advanced or metastatic nonsquamous NSCLC after EGFR-TKI therapy and platinum-based chemotherapy · Sponsor-reported NMPA approval: https://www.prnewswire.com/news-releases/kelun-biotechs-trop2-adc-sacituzumab-tirumotecan-sac-tmt-approved-for-marketing-in-second-indication-by-nmpa-for-egfrm-nsclc-302396917.html |
| China | 2025 | Adults with EGFR-mutated locally advanced or metastatic nonsquamous NSCLC progressing after EGFR-TKI therapy · Sponsor-reported NMPA approval: https://en.kelun-biotech.com/newsCenter.aspx?mid=18&page=5 |
| China | 2026 | Adults with unresectable or metastatic HR-positive/HER2-negative breast cancer after endocrine therapy and at least one chemotherapy line in advanced disease · Sponsor-reported NMPA approval: https://www.prnewswire.com/news-releases/kelun-biotech-announces-fourth-indication-for-sacituzumab-tirumotecan-sac-tmt-approved-by-nmpa-in-hrher2--breast-cancer-302681155.html |
| Adverse event |
|---|
| Neutropenia |
| Anaemia |
| Stomatitis |
| Nausea |
| Alopecia |
Most common grade ≥3 event in OptiTROP-Breast01; rates per publication. Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| China | NMPA approved 2024; National Reimbursement Drug List inclusion from 2025 | not disclosed | - |
| United States | Investigational; not yet approved | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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Query for this drug: (TITLE:"Sacituzumab tirumotecan" OR ABSTRACT:"Sacituzumab tirumotecan" OR TITLE:"sac-TMT" OR ABSTRACT:"sac-TMT" OR TITLE:"MK-2870" OR ABSTRACT:"MK-2870" OR TITLE:"SKB264" OR ABSTRACT:"SKB264") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Sacituzumab tirumotecan, not a curated reading list.
Shares TROP2 PET → TROP2 ADC selection, TROP2 expression, Topoisomerase-I inhibitor payloads, TROP2 PET to choose and sequence TROP2 ADCs.
Shares TROP2 PET → TROP2 ADC selection, TROP2 expression, Topoisomerase-I inhibitor payloads, TROP2 PET to choose and sequence TROP2 ADCs.
Shares TROP2 PET to choose and sequence TROP2 ADCs, TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line, TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET, HER2-low and HER2-ultralow metastatic breast cancer.
Shares T030 (belotecan derivative), Hydrophilic next-generation linkers (TMALIN, Dolaflexin, sulfonyl-pyrimidine, PEG-containing), Efflux-agnostic therapy for mesenchymal TNBC, Topoisomerase-I inhibitor payloads.
Shares A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F), Substudy 06C: A Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With First-Line Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (MK-3475-06C/KEYMAKER-U06), Topoisomerase-I inhibitor payloads, Metastatic triple-negative breast cancer.
Shares TROP2 PET to choose and sequence TROP2 ADCs, TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line, TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET, HER2-low and HER2-ultralow metastatic breast cancer.
Shares TROP2 PET to choose and sequence TROP2 ADCs, TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line, TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET, Metastatic triple-negative breast cancer.
Shares TROP2 PET to choose and sequence TROP2 ADCs, TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line, TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET, Metastatic triple-negative breast cancer.
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