A recent multicenter study, known as the phase III LIBRETTO-431 trial, has assessed the efficacy and safety of selpercatinib as a treatment for non-small cell lung cancer (NSCLC) compared to standard control treatment. The study, published in the New England Journal of Medicine, included Dr. Milena Perez Mak, a researcher at the D’Or Institute for Research and Education (IDOR) and a clinical oncologist at the São Paulo State Cancer Institute (Icesp).
Lung cancer is a prevalent cancer that is known for its high mortality rate. NSCLC is the most common subtype, accounting for approximately 85% of all cases. It originates in the cells of the bronchi and alveoli in the lungs.
The research focused on evaluating the efficacy of selpercatinib in NSCLC patients who had genomic alterations in the RET gene. Selpercatinib is a RET inhibitor that targets the abnormal gene responsible for the proliferation of cancer cells.
Combining chemotherapy with pembrolizumab, an immune checkpoint inhibitor, is the standard treatment for patients with advanced NSCLC. However, its effectiveness in patients with RET gene translocations is uncertain. Therefore, the study aimed to compare the two therapies to determine which treatment is more effective as a first-line approach.
The study included 261 patients from 23 countries who had advanced NSCLC with RET gene translocation between March 2020 and August 2022. These patients were randomly assigned to either the selpercatinib treatment group or the control group. Randomization helped ensure that any observed differences in the results were attributed to the treatment being studied rather than pre-existing differences between the groups. The results revealed that patients who received selpercatinib experienced a significant improvement in cancer progression-free survival, with a median of 24.8 months compared to 11.2 months in the control group.
The researchers also assessed the effectiveness of the treatment on intracranial lesions, as many patients with advanced NSCLC develop brain metastases. At the beginning of the study, 42 patients with brain metastases were identified. Selpercatinib demonstrated the ability to treat existing metastases in the central nervous system and prevent the formation of new intracranial metastases. This finding is particularly significant as treating brain metastases is challenging due to the blood-brain barrier, which restricts the action of most cancer drugs on brain lesions.
The study also evaluated the safety of selpercatinib. Patients who received the treatment experienced different adverse effects compared to chemotherapy, including increased liver enzymes, which were controlled through dose adjustments, and hypertension.
The authors emphasized the importance of conducting molecular tests during the diagnosis process to enable the most appropriate choice of first-line therapy for NSCLC patients with specific molecular characteristics.
This study underscores the significance of tailoring treatment selection for lung cancer patients based on the molecular characteristics of their tumors. Precision medicine can offer better outcomes, as demonstrated by this study. Additionally, the participation of the São Paulo State Cancer Institute in this international clinical study highlights the quality of research in Brazil and the opportunity to include Brazilian patients in global research endeavors, according to Dr. Milena Mak.
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1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it
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