Sacituzumab tirumotecan improved overall survival versus platinum chemotherapy in final phase 3 results
1. In patients with EGFR-mutant advanced non-squamous NSCLC after EGFR-TKI therapy, sacituzumab tirumotecan improved median overall survival versus platinum-based doublet chemotherapy: 25.9 vs 17.4 months.
2. No new safety signals emerged after extended follow-up; common treatment-related adverse events were hematological adverse events and stomatitis.
Evidence Rating Level: 2 (Good)
2MM Brief: Kelun-Biotech reported final overall survival results for sacituzumab tirumotecan in patients with EGFR-mutant locally advanced or metastatic non-squamous non-small cell lung cancer who progressed after EGFR-tyrosine kinase inhibitor therapy. The randomized, multicenter, open-label OptiTROP-Lung04 phase III study enrolled 376 patients, randomized 1:1 to sacituzumab tirumotecan monotherapy or platinum-based doublet chemotherapy with pemetrexed plus platinum. Overall survival was a key secondary endpoint, and the data were presented as an oral presentation at the 2026 European Society for Medical Oncology Congress; the results have not been peer reviewed. At the data cutoff of August 6, 2026, median follow-up was 32.3 months. Median overall survival was 25.9 months with sacituzumab tirumotecan versus 17.4 months with platinum-based doublet chemotherapy, with a hazard ratio for death of 0.69 (95% CI 0.54–0.89; one-sided P = 0.0021). The 2-year overall survival rate was 54.1% versus 37.2%, and the release reported that the survival benefit was sustained. In a prespecified rank-preserving structural failure time model-adjusted analysis accounting for subsequent antibody-drug conjugate therapy, median overall survival was 25.9 versus 16.6 months, with a hazard ratio of 0.57 (95% CI 0.42–0.75). The release stated that 22.6% of patients in the chemotherapy group received subsequent antibody-drug conjugate therapy. No new safety signals were identified after extended follow-up. The most common treatment-related adverse events were hematological adverse events and stomatitis; stomatitis was mostly Grade 1–2, with Grade 3 events reported in 4.8%. Interstitial lung disease/pneumonitis occurred in 1 case (0.5%) in the sacituzumab tirumotecan group and 2 cases (1.1%) in the chemotherapy group, all Grade 1–2. Interpretation is limited by the open-label design, the company-reported, non-peer-reviewed source, and the use of a model-adjusted secondary analysis. These results support sacituzumab tirumotecan as a potential treatment option in this study population, pending review of the full presented data.
Click here to read the press release from Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
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