The Sac-TMT combination with pembrolizumab reduced the risk of disease progression or death by 51% versus chemotherapy plus pembrolizumab in a Phase III lung cancer trial, Kelun-Biotech announced on October 25, 2026. The interim findings concern first-line treatment of PD-L1-negative, EGFR/ALK-negative advanced non-squamous non-small cell lung cancer.
Key Takeaways
- The trial met its primary progression-free survival endpoint, with a hazard ratio of 0.49.
- Median response duration was 13.6 months with sac-TMT plus pembrolizumab, versus 6.8 months in the comparison group.
- Overall survival remained immature, with the median not reached in either treatment group.
Table of Contents
- Sac-TMT combination extends disease control
- Safety findings favor the experimental regimen
- Results expand evidence for a partnered cancer drug
- Conclusion
Sac-TMT combination extends disease control
The OptiTROP-Lung06 results were presented by Professor Caicun Zhou of Shanghai East Hospital, Tongji University, at the European Society for Medical Oncology Congress in Madrid. Kelun-Biotech said the findings were simultaneously published in The New England Journal of Medicine.
Blinded independent central review found a progression-free survival hazard ratio of 0.49, with a 95% confidence interval of 0.36–0.65. The reported 51% reduction describes the relative hazard of progression or death during follow-up, not an absolute reduction in the percentage of patients experiencing those outcomes.
Tumor response rates were relatively close, but responses lasted longer with the sac-TMT regimen. The hazard ratio for duration of response was 0.47, with a 95% confidence interval of 0.29–0.77.
Overall survival showed a favorable trend, with a hazard ratio of 0.58 and a 95% confidence interval of 0.38–0.88. However, these were interim results, and median overall survival had not been reached in either group.
| Item | Details |
|---|---|
| Study design | Randomized, multicenter, open-label Phase III trial involving 455 patients, allocated 1:1. |
| Comparison treatment | Pembrolizumab plus pemetrexed and either cisplatin or carboplatin. |
| Data timing | June 9, 2026 cutoff; median follow-up of 9.7 months. |
| Objective response rate | 50.2% with sac-TMT plus pembrolizumab versus 47.3% with chemotherapy plus pembrolizumab. |
| Deep response rate | 28.8% versus 17.3%; defined as a complete or partial response with at least 50% shrinkage in the sum of target lesion diameters. |
Safety findings favor the experimental regimen
Kelun-Biotech said the sac-TMT group had lower incidences of grade 3 or higher treatment-emergent adverse events and adverse events leading to dose reductions or permanent discontinuation than the chemotherapy comparison group. The announcement did not provide numerical rates for those measures.
No new safety signals were observed, and the incidence of interstitial lung disease or pneumonitis was similar between the groups. The company described the combination’s safety profile as generally consistent with the known profiles of the individual drugs.
Results expand evidence for a partnered cancer drug
Sacituzumab tirumotecan, also called sac-TMT or MK-2870, is designed to deliver a cancer-killing payload to targeted cells. MSD’s description of sac-TMT’s mechanism identifies it as an antibody-drug conjugate targeting TROP2 and carrying a belotecan-derived payload.
Kelun-Biotech licensed exclusive rights to develop, manufacture and commercialize the drug outside Greater China to MSD, the name used by Merck & Co. internationally, in May 2022. The new findings add Phase III evidence for combining the drug with MSD’s pembrolizumab, marketed as Keytruda.
The study result is distinct from regulatory approval for this treatment setting. Kelun-Biotech said sac-TMT already had four approved indications in China, but those existing approvals cover other breast cancer and EGFR-mutated lung cancer settings.
Conclusion
The Sac-TMT combination met the trial’s primary disease-control endpoint. Overall survival, a secondary endpoint, remains the key unresolved outcome as follow-up continues; the announcement gave no date for the next analysis.
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