Final OS Analysis of Sacituzumab Tirumotecan in EGFR-Mutated Advanced NSCLC
OptiTROP-Lung04 is a randomized, multicenter, open-label Phase III study evaluating sac-TMT monotherapy against platinum-based doublet chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC whose disease progressed following EGFR-TKI treatment. A total of 376 patients were randomized 1:1 to receive sac-TMT at 5 mg/kg every two weeks or platinum-based doublet chemotherapy consisting of pemetrexed plus platinum. The primary endpoint was progression-free survival (PFS) assessed by blinded independent central review (BICR), while OS was a key secondary endpoint. The final OS analysis was presented at ESMO 2026 after a median follow-up of 32.3 months, using a data cutoff of August 6, 2026.
|
Key Efficacy and Safety Highlights | |||
|
Category |
Parameter |
SacTMT (n=188) |
Platinum-based doublet chemotherapy |
|
Efficacy |
Median follow-up |
32.3 months |
32.3 months |
|
Median OS |
25.9 months |
17.4 months | |
|
OS hazard ratio |
0.69 |
Comparator arm | |
|
Statistical significance for OS |
p=0.0021 |
— | |
|
2-year OS rate |
54.1% |
37.2% | |
|
Median OS after RPSFT adjustment |
25.9 months |
16.6 months | |
|
Adjusted OS hazard ratio |
0.57 |
Comparator arm | |
|
Safety |
Subsequent ADC treatment |
— |
22.6% of patients |
|
Grade 3 stomatitis |
4.8% |
Not specified in the cited release | |
|
Interstitial lung disease/pneumonitis |
1 patient (0.5%); Grade 1–2 |
2 patients (1.1%); Grade 1–2 | |
Conclusion
The final OS analysis of OptiTROP-Lung04 provides important long-term evidence for sacituzumab tirumotecan in EGFR-mutated advanced NSCLC following EGFR-TKI progression. The 8.5-month improvement in median OS and higher 2-year survival rate support its potential as an alternative to platinum-based doublet chemotherapy in this setting. The RPSFT-adjusted analysis further supports the durability of the survival signal, while the extended safety follow-up revealed no new safety concerns. Importantly, sac-TMT had already received approval in China for this treatment setting in September 2025; the ESMO 2026 findings therefore add mature survival evidence to its clinical profile rather than representing a first approval.