WCLC 2025 - Posters & ePosters-P3.12.36 Multicenter Retrospective Study of Selpercatinib Treatment for Advanced or Recurrent RET Fusion-Positive NSCLC in Japan

P3.12.36 Multicenter Retrospective Study of Selpercatinib Treatment for Advanced or Recurrent RET Fusion-Positive NSCLC in Japan

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This multicenter retrospective cohort study in Japan evaluated the real-world effectiveness and safety of selpercatinib, a selective RET kinase inhibitor, in 27 patients with advanced or recurrent RET fusion-positive non-small cell lung cancer (RET-NSCLC). Patients were treated across 11 institutions between September 2021 and June 2024, including both treatment-naïve (17 patients) and previously treated (10 patients) groups.<br /><br />Key outcomes included an overall objective response rate (ORR) of 78% (21/27 patients). ORRs were 80% in the previously treated group and 76% in the treatment-naïve group. Median progression-free survival (mPFS) was 23.5 months overall, with treatment-naïve patients showing a longer mPFS (23.5 months) compared to previously treated patients (13.3 months), although this difference was not statistically significant (p=0.482). Median overall survival (mOS) was not reached, with 1-year OS rates around 88%. Similarly, no significant difference in survival was observed based on PD-L1 tumor proportion score (TPS), with high TPS (≥50%) patients showing ORR of 90% and low TPS (<50%) patients showing ORR of 85%.<br /><br />Regarding safety, grade 3 liver enzyme elevation (ALT increase) occurred in 41% of patients, indicating a higher incidence of severe liver dysfunction compared to global clinical trials (LIBRETTO-001 and LIBRETTO-431). This suggests that Japanese patients may experience more pronounced hepatic adverse events from selpercatinib.<br /><br />In summary, selpercatinib demonstrated high efficacy in Japanese patients with RET fusion-positive NSCLC regardless of prior treatment or PD-L1 status. However, increased liver toxicity highlights the need for careful monitoring in this population. These findings support selpercatinib as a valuable treatment option while emphasizing the importance of managing adverse events in real-world Japanese clinical settings.

Asset Subtitle

Yasuhiro Mihashi

Meta Tag

Speaker Yasuhiro Mihashi

Topic Metastatic Non-small Cell Lung Cancer – Targeted Therapy

Keywords

selpercatinib

RET fusion-positive non-small cell lung cancer

RET-NSCLC

real-world effectiveness

Japan multicenter study

objective response rate

progression-free survival

overall survival

liver enzyme elevation

PD-L1 tumor proportion score