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Pralsetinib: A Review in Advanced RET Fusion-Positive NSCLC
1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. demail@springer.com.
Abstract:
Activating mutations in the proto-oncogene RET have been identified as an oncogenic driver of non-small cell lung cancer (NSCLC) in a small subset of patients. Pralsetinib (Gavreto®) is an orally-administered, next-generation, small-molecule selective RET inhibitor that is approved for the treatment of RET fusion-positive metastatic NSCLC. In the pivotal phase I/II ARROW trial, pralsetinib demonstrated rapid and durable anti-tumour activity in patients with advanced RET fusion-positive NSCLC who were previously treated with platinum-based chemotherapy or were treatment-naïve. Pralsetinib also showed clinical activity against intracranial metastases arising from NSCLC. Pralsetinib had a manageable tolerability profile, with the most common grade 3 treatment-related adverse events being neutropenia, hypertension, anaemia and decreased white blood cell count. Currently available data indicate that pralsetinib is a promising new targeted treatment option for patients with advanced RET fusion-positive NSCLC.
Insights
Pralsetinib is an effective targeted therapy for advanced RET fusion-positive non-small cell lung cancer (NSCLC). This RET inhibitor shows significant anti-tumour activity, including in brain metastases, with a manageable safety profile.
Area of Science:
- Oncology
- Pharmacology
Background:
- Activating mutations in the proto-oncogene RET are key drivers in a subset of non-small cell lung cancer (NSCLC).
- Pralsetinib is an approved, next-generation selective RET inhibitor for RET fusion-positive metastatic NSCLC.
Purpose of the Study:
- To evaluate the efficacy and safety of pralsetinib in patients with advanced RET fusion-positive NSCLC.
Main Methods:
- Pivotal phase I/II ARROW trial.
- Oral administration of pralsetinib in patients with advanced RET fusion-positive NSCLC, including those previously treated or treatment-naïve.
- Assessment of anti-tumour activity, including intracranial metastases, and tolerability.
Main Results:
- Pralsetinib demonstrated rapid and durable anti-tumour activity.
- Clinical activity was observed against intracranial metastases.
- The drug exhibited a manageable tolerability profile, with common grade 3 adverse events including neutropenia and hypertension.
Conclusions:
- Pralsetinib is a promising targeted treatment for advanced RET fusion-positive NSCLC.
- The drug offers a new therapeutic option for patients with this specific genetic alteration.
- Favorable efficacy and safety data support its role in clinical practice.
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