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Updated: Aug 20, 2025
Author Spotlight: Advancements in Molecular Biomarker Testing for Non-Squamous Non-Small Cell Lung Cancer
Published on: September 8, 2023
Selpercatinib: A Review in Advanced RET Fusion-Positive NSCLC
1Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand. demail@springer.com.
Abstract:
Selpercatinib (Retevmo®/Retsevmo®) is an orally-administered, selective inhibitor of rearranged during transfection (RET) kinase approved for the treatment of advanced RET fusion-positive non-small cell lung cancer (NSCLC). In a pivotal phase 1/2 clinical trial in this population, selpercatinib treatment was associated with robust and durable responses, including intracranial responses, in patients previously treated with platinum-based chemotherapy, as well as in treatment-naïve patients. Selpercatinib had a manageable tolerability profile and an acceptable safety profile; adverse events could generally be managed with dose reductions and only a small proportion of patients discontinued selpercatinib due to treatment-related adverse events. The most common treatment-related adverse events that were grade 3-4 in severity were hypertension, elevated alanine aminotransferase and elevated aspartate aminotransferase. Thus, currently available evidence suggests that selpercatinib is a promising new RET-targeted therapy option for patients with advanced RET fusion-positive NSCLC.
Insights
Selpercatinib is an effective treatment for advanced rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC). This targeted therapy shows durable responses, including in the brain, with a manageable safety profile.
Area of Science:
- Oncology
- Pharmacology
- Genetics
Background:
- Non-small cell lung cancer (NSCLC) with rearranged during transfection (RET) fusions represents a distinct molecular subtype.
- Targeted therapies offer improved outcomes for specific genetic alterations in NSCLC.
Purpose of the Study:
- To evaluate the efficacy and safety of selpercatinib, a selective RET kinase inhibitor, in patients with advanced RET fusion-positive NSCLC.
Main Methods:
- A pivotal phase 1/2 clinical trial was conducted in patients with advanced RET fusion-positive NSCLC.
- Patients included those previously treated with chemotherapy and treatment-naïve individuals.
Main Results:
- Selpercatinib demonstrated robust and durable overall responses, including intracranial activity.
- The drug exhibited a manageable tolerability and acceptable safety profile, with most adverse events managed by dose adjustments.
Conclusions:
- Selpercatinib is a promising targeted therapy for advanced RET fusion-positive NSCLC.
- It offers significant clinical benefit with a favorable safety profile in both previously treated and treatment-naïve patients.
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