Sac-TMT trial results announced by Kelun-Biotech on October 24, 2026, showed a 68% confirmed objective response rate when the drug was combined with pembrolizumab in 40 patients with previously untreated advanced urothelial carcinoma who were ineligible for cisplatin. The Phase II findings support further development, although 63% of patients experienced grade 3 or higher treatment-related adverse events.
Key Takeaways
- Median response duration was 19.4 months after a median follow-up of 22.8 months.
- Treatment-related adverse events led to permanent discontinuation of sac-TMT in 8% of patients; none were fatal.
- Kelun-Biotech said the findings support initiation of the global Phase III TroFuse-055 study.
Table of Contents
- Sac-TMT trial findings cover 40 untreated patients
- Safety findings temper the response results
- Development builds on Kelun-Biotech’s MSD partnership
- Conclusion
Sac-TMT trial findings cover 40 untreated patients
The results came from cohort B of MK-2870-002/SKB264-II-06, an international, multicenter, open-label Phase II basket study. Participants had locally advanced or metastatic urothelial carcinoma, had received no previous systemic therapy and were ineligible for cisplatin.
Professor Xiaojie Bian of Fudan University Shanghai Cancer Center presented the update at the European Society for Medical Oncology Congress in Madrid. The data cutoff was January 26, 2026, several months before the October presentation.
Median progression-free survival, the time before disease progression or death, was 11.2 months. Median overall survival had not been reached at the cutoff, so the study had not yet established that survival estimate.
Responses were observed across TROP2 and PD-L1 expression levels. However, the small cohort and absence of a reported control-group comparison mean these results do not establish that the combination is superior to another treatment.
| Item | Details |
|---|---|
| Sac-TMT doses | 4 mg/kg or 5 mg/kg, combined with pembrolizumab |
| Confirmed disease control rate | 88% |
| Progression-free survival uncertainty | 95% confidence interval: 5.8 months to not reached |
| Overall survival uncertainty | 95% confidence interval: 17.2 months to not reached |
Safety findings temper the response results
The most common grade 3 or higher treatment-related adverse events were anemia, decreased neutrophil count and stomatitis. These findings make toxicity an important part of assessing the combination alongside its antitumor activity.
A small number of patients developed ocular surface toxicity, with all cases grade 2 or lower. No interstitial lung disease or pneumonitis was observed, and no fatal treatment-related adverse events occurred.
Kelun-Biotech described the safety profile as manageable and consistent with the known profiles of the individual drugs. That assessment accompanies, rather than replaces, the reported frequency of higher-grade adverse events.
Development builds on Kelun-Biotech’s MSD partnership
Sacituzumab tirumotecan, also called sac-TMT, SKB264 or MK-2870, is a TROP2-targeting antibody-drug conjugate. MSD’s description of sacituzumab tirumotecan explains that it links a TROP2-targeting antibody to a belotecan-derived payload. Pembrolizumab, marketed as Keytruda, is MSD’s anti-PD-1 antibody.
Kelun-Biotech licensed MSD exclusive rights to develop, use, manufacture and commercialize sac-TMT outside Greater China in May 2022. The company said sac-TMT already had four approved indications in China covering specified breast and lung cancer settings; those approvals are separate from the urothelial cancer combination studied here.
The company said the Phase II data support initiation of the global Phase III TroFuse-055 study, identified as NCT07829783. The announcement did not provide a start date or a timetable for results.
Conclusion
The Sac-TMT trial provides evidence of antitumor activity in a small, previously untreated urothelial cancer cohort, alongside substantial higher-grade toxicity. The next development step identified by Kelun-Biotech is the global Phase III TroFuse-055 study, with timing not specified in the announcement.
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