Sacituzumab tirumotecan significantly improved progression-free survival and overall survival in patients with EGFR-mutated NSCLC resistant to previous EGFR-TKI therapy compared to standard chemotherapy. The treatment was associated with a lower incidence of serious adverse events.
Study
|
Phase 3, open-label, multicenter, randomized trial [OptiTROP-Lung04] |
| EGFR-mutated locally advanced or metastatic non-squamous NSCLC resistant to EGFR-TKI therapy |
| Sacituzumab Tirumotecan (n=188) vs Pemetrexed plus platinum-based chemotherapy (n=188)
|
Efficacy
|
ORR: 60.6% vs 43.1% |
| mPFS: 8.3 mos vs 4.3 mos (HR 0.49 [0.39-0.62]) |
| 18-month OS: 65.8% vs 48.0% (HR 0.60 [0.44-0.82])
|
Safety
|
Grade >=3 AEs: decreased neutrophil count (39.9% vs 33.0%) |
| Serious AEs: 9.0% vs 17.6% |
| Treatment discontinuation rate due to AEs: 0% vs 0.5%
|
N Engl J Med. Published online October 19, 2025
Fang W, Wu L, Meng X New Drug: Sacituzumab Tirumotecan for EGFR-Mutated Advanced NSCLC
http://doi.org/10.1056/NEJMoa2512071
Reviewed by Ulas D. Bayraktar, MD on Nov 17, 2025
