First-line Selpercatinib or Chemotherapy and Pembrolizumab in Patients From East Asia With RET Fusion-Positive NSCLC: A LIBRETTO-431 Subgroup Analysis
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Summary
This summary is machine-generated.Selpercatinib significantly improved progression-free survival in East Asian patients with RET fusion-positive non-small cell lung cancer compared to chemotherapy. This targeted therapy demonstrates a manageable safety profile, supporting its use as a preferred first-line treatment.
Area Of Science
- Oncology
- Genetics
- Pharmacology
Background
- Selpercatinib has shown consistent efficacy and safety in <i>RET</i> fusion-positive non-small cell lung cancer (NSCLC) in global single-arm studies.
- The LIBRETTO-431 phase 3 trial evaluated selpercatinib in first-line treatment of NSCLC, with geography as a stratification factor.
Purpose Of The Study
- To report the efficacy and safety of selpercatinib in patients from East Asia within the LIBRETTO-431 phase 3 trial.
- To compare first-line selpercatinib with chemotherapy (pemetrexed and platinum with or without pembrolizumab) in East Asian patients with <i>RET</i> fusion-positive NSCLC.
Main Methods
- A randomized, open-label phase 3 trial (LIBRETTO-431) comparing selpercatinib to chemotherapy.
- Efficacy endpoints included progression-free survival (PFS), objective response rate, and duration of response, assessed by blinded independent central review.
- Safety and pharmacokinetic data were collected for all participants.
Main Results
- In East Asian patients (n=142), selpercatinib demonstrated superior PFS compared to the control group (median not reached vs. 11.1 months).
- The hazard ratio for PFS was 0.38 (95% CI: 0.22-0.68; p = 0.0008), indicating a significant benefit.
- Safety and pharmacokinetic profiles were consistent with previous studies and generally manageable.
Conclusions
- Selpercatinib showed superior PFS versus chemotherapy plus pembrolizumab in East Asian patients with <i>RET</i> fusion-positive NSCLC.
- The safety profile was manageable, reinforcing selpercatinib's role as a preferred first-line treatment.
- These findings underscore the importance of comprehensive genomic testing for identifying eligible patients.
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