Kelun sac-TMT final survival analysis sustains lung benefit

Kelun-Biotech and Merck's sacituzumab tirumotecan sustained its survival benefit at the final overall survival analysis of the Phase 3 OptiTROP-Lung04 trial, with 54.1 percent of patients alive at two years against 37.2 percent on chemotherapy.

Why it matters: Yesterday's edition could only flag this presentation as pending. The final analysis closes the survival question for sac-TMT in EGFR-mutated lung cancer after EGFR inhibitor failure, the indication already approved in China, and sets the benchmark Merck's global TroFuse program has to match.

Data as of Phase 3 OptiTROP-Lung04, prespecified final overall survival analysis at median follow-up of 32.3 months, abstract LBA67 presented at ESMO 2026 on October 25, 2026. Primary source is the Kelun-Biotech PR Newswire release of October 25, 2026. The adjusted survival figure cited is a prespecified model adjusting for later ADC treatment, not the unadjusted primary comparison.

The prespecified final overall survival analysis of the Phase 3 OptiTROP-Lung04 trial of sacituzumab tirumotecan, or sac-TMT, showed a sustained survival benefit for the TROP2 antibody-drug conjugate over platinum doublet chemotherapy in EGFR-mutated locally advanced or metastatic non-squamous lung cancer after EGFR inhibitor failure, Kelun-Biotech announced at ESMO on October 25. At a median follow-up of 32.3 months, 54.1 percent of sac-TMT patients were alive at two years against 37.2 percent on chemotherapy, a difference of 16.9 percentage points. In addition, 22.6 percent of patients in the chemotherapy arm later received an antibody-drug conjugate, the release noted, which dilutes an unadjusted survival comparison.

Adjusting for that later ADC treatment using the prespecified rank-preserving structural failure time model, the risk of death was reduced by 43 percent (hazard ratio 0.57, 95 percent confidence interval 0.42 to 0.75), and adjusted median survival differed by 9.3 months, 25.9 months against 16.6 months. That adjusted figure is a model-based estimate and should be read as such. The unadjusted foundations are not in dispute: the trial’s final progression-free survival analysis, published in The New England Journal of Medicine in 2025, showed a 51 percent reduction in the risk of progression or death (hazard ratio 0.49), and sac-TMT was approved by China’s National Medical Products Administration in September 2025 for this indication.

This story is the resolution of an item yesterday’s edition carried as pending, a final survival presentation with no results yet published. The results are now published, and they sustain, rather than reverse, the interim picture.

For Merck, which partners sac-TMT globally as MK-2870, the China dataset is the proof of concept behind its TroFuse trial program in Western populations. A final survival analysis that holds up at 32 months of follow-up strengthens that program’s premise, but it does not substitute for the global randomised data regulators outside China will require.

Kelun sac-TMT final survival analysis sustains lung benefit

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