The OptiTROP-Lung05 phase 3 trial demonstrated that sacituzumab tirumotecan combined with pembrolizumab significantly improved progression-free survival and objective response rate compared to pembrolizumab alone in patients with PD-L1-positive advanced NSCLC without targetable genomic alterations. The combination had a higher incidence of manageable hematological and stomatitis adverse events but did not increase treatment discontinuations.
Study
|
Randomised, open-label, phase 3 trial [OptiTROP-Lung05] |
| PD-L1-positive advanced NSCLC without targetable genomic alterations |
| Sac-TMT plus pembrolizumab (n=208) vs pembrolizumab (n=205)
|
Efficacy
|
ORR: 70% vs 42% (Sac-TMT + pembrolizumab vs. pembrolizumab) |
| mPFS: NR vs 5.7 mos (HR 0.35 [0.26-0.47]) |
| 1yr PFS: 62% vs 29% |
| mOS: NR vs 14.5 mos (HR 0.55 [0.36-0.85]) |
| 1yr OS: 80% vs 69%
|
Safety
|
Grade >=3 AE: neutropenia (17% vs <1%), anemia (9% vs 1%), pneumonia (8% vs 5%), stomatitis (5% vs 0%) |
| Serious AEs: 39% vs 29% |
| Treatment discontinuation due to AEs: 4% vs 5% |
| Death due to AEs: 2% vs 6%
|
Lancet. Published online 2026 May 29
http://doi.org/10.1016/S0140-6736(26)00968-2
Reviewed by Ulas D. Bayraktar, MD on Jun 17, 2026
