OptiTROP-Lung04 improves EGFRm NSCLC outcomes
“We think sac-TMT will provide a promising new treatment option for patients with EGFR-mutated NSCLC.” Li Zhang discusses the findings of the OptiTROP-Lung04 trial and their relevance to everyday clinical practice. View transcript.
Results of OptiTROP-Lung04 show increased survival rates with sacituzumab tirumotecan over platinum-based chemotherapy in epidermal growth factor receptor (EGFR)-mutated advanced or metastatic non–small-cell lung cancer (NSCLC).
The phase 3 trial data, presented at the European Society for Medical Oncology (ESMO) Congress 2025 in Berlin, Germany, focused on progression-free survival (PFS) and overall survival (OS) outcomes in patients with EGFR-mutated NSCLC who had progressed after previous EGFR–tyrosine kinase inhibitor (TKI) therapy. The median follow-up was 18.9 months.
Li Zhang (Sun Yat-Sen University, Guangzhou, China) reported that median PFS by blinded independent review was significantly higher with sacituzumab tirumotecan 5 mg/kg every 2 weeks (n=188), at 8.3 months compared with 4.3 months with chemotherapy (n=188; HR, 0.49). This benefit was consistent in all predefined subgroups. PFS at 12 months was 32.3% with sacituzumab tirumotecan and 7.9% with chemotherapy.
Zhang said that median OS was significantly longer with sacituzumab tirumotecan versus chemotherapy (HR for death, 0.60). Median OS was not reached in the sacituzumab tirumotecan arm and was 17.4 months in the chemotherapy arm. At 18 months, OS was 65.8% with sacituzumab tirumotecan and 48.0% with chemotherapy. Again, this was consistent across subgroups.
There were no unexpected safety signals. The incidence of grade ≥3 treatment-related adverse events (TRAEs) was similar in both arms, while there were fewer serious TRAEs with sacituzumab tirumotecan than chemotherapy (9.0% vs 17.6%). The most common TRAEs in both groups were hematologic toxicities. Zhang noted a higher incidence of stomatitis in the sacituzumab tirumotecan group, although most events were mild and manageable.
The trial results were simultaneously released in The New England Journal of Medicine.
Discussant Antonio Passaro (European Institute of Oncology, Milan, Italy) commented that the OptiTROP-Lung04 results were “clearly positive” and, regarding safety, said “globally, these data are very reassuring for the oncology community.”
However, Passaro explained that the OptiTROP-Lung04 protocol was not well designed to investigate the effects on brain metastases, which would be key to develop understanding of intracranial efficacy in this setting. Passaro said “we need to raise the bar” and suggested a global study beyond China would be beneficial.
Li Zhang shares his personal highlights from ESMO Congress 2025, focusing on the surge in promising randomized phase 3 trials in NSCLC. View transcript.
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