June 13, 2025
Source: drugdu
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Drugdu.com expert's response:
I. Clinical Research Data
KL264-01 Study: In the subgroup analysis targeting EGFR-mutated non-small cell lung cancer (NSCLC) patients, the objective response rate (ORR) of sacituzumab tirumotecan as a monotherapy reached as high as 55%, with a median progression-free survival (PFS) of 11.1 months. These results were significantly superior to those in EGFR wild-type patients, who had an ORR of 24% and a median PFS of 5.3 months.
SKB264-II-08 Study: Among 64 previously treated EGFR-mutated NSCLC patients, sacituzumab tirumotecan achieved an ORR of 34%, a disease control rate (DCR) of 84%, a median duration of response (DOR) of 9.6 months, a median PFS of 9.3 months, and a 1-year overall survival (OS) rate of 79%.
OptiTROP-Lung03 Study: The sacituzumab tirumotecan group demonstrated a confirmed ORR of 45.1%, significantly higher than the 15.6% in the docetaxel group. The median PFS was 6.9 months, significantly longer than the 2.8 months in the docetaxel group. Although the median OS had not yet been reached, a statistically significant advantage was already evident (HR=0.49, 95% CI: 0.27-0.88; one-sided p=0.007).
II. Efficacy Characteristics
Significant Efficacy in EGFR-Mutated NSCLC Patients: Sacituzumab tirumotecan exhibited a higher ORR and longer PFS in EGFR-mutated NSCLC patients, offering a new treatment option for this patient population.
Manageable Safety Profile: Sacituzumab tirumotecan demonstrated good safety, with the main treatment-related adverse events being hematological toxicities. Most patients recovered after receiving symptomatic treatment.
III. Clinical Significance
Filling the Treatment Gap: The approval and launch of sacituzumab tirumotecan have filled the gap in treatment options for EGFR-TKI-resistant patients, providing a new therapeutic choice for EGFR-mutated NSCLC patients.
Advancing Clinical Treatment: The remarkable efficacy and manageable safety of sacituzumab tirumotecan are expected to drive progress in the clinical treatment of NSCLC and potentially rewrite existing tumor treatment guidelines.
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