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Published on: September 8, 2023
Selpercatinib in Early-Stage RET Fusion-Positive Non-Small-Cell Lung Cancer.
Yi-Long Wu1, Maximilian Hochmair2, Yi Yang3
1Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China.
The New England Journal of Medicine
|June 1, 2026
Summary
Adjuvant selpercatinib significantly improved event-free survival in patients with RET fusion-positive non-small-cell lung cancer (NSCLC). This targeted therapy offers a promising new option for early-stage NSCLC patients following definitive treatment.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Selpercatinib is an approved RET inhibitor for advanced RET fusion-positive non-small-cell lung cancer (NSCLC).
- The efficacy and safety of selpercatinib in early-stage NSCLC remained unknown prior to this study.
Purpose of the Study:
- To evaluate the efficacy and safety of adjuvant selpercatinib in patients with RET fusion-positive NSCLC after definitive therapy.
- To assess event-free survival (EFS) as the primary endpoint in patients with stage II or IIIA disease.
Main Methods:
- A phase 3, double-blind, randomized trial (LIBRETTO-432) was conducted.
- Patients with RET fusion-positive NSCLC received adjuvant selpercatinib or placebo for up to 3 years.
- Key endpoints included investigator-assessed EFS, blinded independent central review EFS, overall survival, and safety.
Main Results:
- In patients with stage II or IIIA disease, 2-year EFS was 92% with selpercatinib vs. 61% with placebo (HR 0.17, P<0.001).
- For patients with stage IB-IIIA disease, 2-year EFS was 94% with selpercatinib vs. 70% with placebo (HR 0.17, P<0.001).
- Common adverse events included elevated liver enzymes; three deaths occurred in the placebo group due to disease progression.
Conclusions:
- Adjuvant selpercatinib demonstrated a significant improvement in event-free survival for patients with stage II or IIIA RET fusion-positive NSCLC.
- Selpercatinib represents a potential new standard of care for adjuvant therapy in this patient population.
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