The Sac-TMT trial showed longer median overall survival than chemotherapy in patients with a specific form of advanced lung cancer, Kelun-Biotech said on October 25, 2026. Final results from the Phase III study were presented at the European Society for Medical Oncology Congress in Madrid.

Key Takeaways

  • Median overall survival was 25.9 months with sac-TMT and 17.4 months with platinum-based doublet chemotherapy.
  • The study enrolled 376 patients whose EGFR-mutant lung cancer had progressed after EGFR-targeted treatment.
  • China approved sac-TMT for this patient group in September 2025; another lung cancer indication is under review.

Sac-TMT trial survival results

The randomized, open-label OptiTROP-Lung04 study compared sacituzumab tirumotecan, or sac-TMT, alone with pemetrexed plus platinum chemotherapy. It enrolled patients with EGFR-mutant, locally advanced or metastatic non-squamous non-small cell lung cancer whose disease had progressed after EGFR-tyrosine kinase inhibitor therapy.

After a median follow-up of 32.3 months, the trial showed a 31% reduction in the risk of death with sac-TMT versus chemotherapy. The hazard ratio was 0.69, with a 95% confidence interval of 0.54 to 0.89. Overall survival was a key secondary endpoint.

The two-year overall survival rate was 54.1% with sac-TMT and 37.2% with chemotherapy. The data cutoff for the final analysis was August 6, 2026.

Follow-up treatment and safety

In the chemotherapy group, 22.6% of patients subsequently received an antibody-drug conjugate. In a prespecified analysis adjusting for that subsequent treatment, the estimated median survival was 25.9 months for sac-TMT versus 16.6 months for chemotherapy. The adjusted hazard ratio was 0.57.

Kelun-Biotech said no new safety signals were identified after extended follow-up. The most common treatment-related adverse events were blood-related events and stomatitis, or inflammation of the mouth. Grade 3 stomatitis occurred in 4.8% of patients.

Interstitial lung disease or pneumonitis was reported in one patient, or 0.5%, in the sac-TMT group and two patients, or 1.1%, in the chemotherapy group. All cases were Grade 1 or 2.

Approvals and commercial rights

China's National Medical Products Administration approved sac-TMT in September 2025 for adults in the patient group studied. That approval followed results from the trial's final progression-free survival analysis and interim overall survival analysis, which were published online in 2025.

Kelun-Biotech has licensed Merck, known as MSD outside the United States and Canada, exclusive rights to develop and commercialize sac-TMT outside Greater China. The company said China's regulator has accepted an application to review sac-TMT with pembrolizumab as a first-line treatment for a separate group of patients with locally advanced or metastatic non-small cell lung cancer.

Next milestone

The next confirmed regulatory step is China's review of the separate application for sac-TMT combined with pembrolizumab as a first-line lung cancer treatment.

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