At ESMO in Madrid
The Phase III OptiTROP-Lung06 results for sacituzumab tirumotecan (sac-TMT) were presented as an oral presentation at the 2026 European Society for Medical Oncology Congress in Madrid and published at the same time in The New England Journal of Medicine, the company said. Professor Caicun Zhou of Shanghai East Hospital, Tongji University presented the data and said the readout, together with the earlier OptiTROP-Lung05 results presented at 2026 ASCO, provided Phase III evidence for the combination as a first-line treatment in NSCLC patients without actionable genomic alterations, regardless of PD-L1 expression.
Trial design
Kelun-Biotech said OptiTROP-Lung06 (NCT06711900) randomised 455 patients 1:1 to sac-TMT plus pembrolizumab or to platinum-based doublet chemotherapy (pemetrexed plus cisplatin or carboplatin) plus pembrolizumab. Progression-free survival as assessed by blinded independent central review is the primary endpoint, and overall survival is a secondary endpoint. The data cut-off was June 9, 2026, and median follow-up was 9.7 months. The company described the study as the first Phase III trial of an antibody-drug conjugate combined with an immune checkpoint inhibitor to meet its primary endpoint in first-line treatment of driver gene-negative, PD-L1-negative non-squamous NSCLC.
Efficacy figures
In patients with PD-L1 tumour proportion score <1%, EGFR mutation-negative and ALK-negative advanced non-squamous NSCLC, blinded independent central review found the risk of disease progression or death 51% lower with the sac-TMT combination (HR 0.49; 95% CI 0.36-0.65; P<0.0001), with median progression-free survival of 15.0 months and 5.7 months in the two groups. Median duration of response was 13.6 months and 6.8 months (HR 0.47; 95% CI 0.29-0.77), the objective response rate was 50.2% and 47.3%, and the deep response rate was 28.8% and 17.3%. The overall survival hazard ratio was 0.58 (95% CI 0.38-0.88), and median overall survival was not reached in either group.
Safety
The company said the safety profile of sac-TMT plus pembrolizumab was generally consistent with that known for the individual agents and that no new safety signals were observed. Grade 3 or higher treatment-emergent adverse events, and events leading to dose reduction or permanent discontinuation, were less frequent than in the chemotherapy combination group, and the incidence of interstitial lung disease or pneumonitis was similar between the groups.
