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David S. Ettinger, MD, FACP, FCCP


Update From LIBRETTO-001: Selpercatinib in RET Fusion–Positive NSCLC

By: Victoria Kuhr, BA
Posted: Wednesday, April 20, 2022

Alexander Drilon, MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues, reported that with longer follow-up and additional patients from the LIBRETTO-001 trial, selpercatinib demonstrated “durable” efficacy and intracranial activity regardless of the line of therapy in patients with RET fusion–positive non–small cell lung cancer (NSCLC). The safety profile of this RET kinase inhibitor remained consistent with that of previous reports. These study findings were presented at the European Lung Cancer Congress (ELCC) 2022 (Abstract 27P).

The updated analysis from this trial was 15 months from the previous analysis. The study measured objective response rate by independent review committee, clinical benefit rate, overall survival, and safety.

The study focused on 69 treatment-naive patients and 247 patients previously treated with platinum chemotherapy. Despite a median follow-up of approximately 4 months in these patients, the median duration of response and progression-free survival estimates are still not mature. Among all patients with NSCLC, the independent review committee reported that 26 had measurable central nervous system metastases at baseline. Selpercatinib treatment resulted in a central nervous system objective response rate of 84.6%, with a central nervous system median duration of response of 9.4 months at a median follow-up of 25.8 months.

Patients treated with more than one dose of selpercatinib (n = 356) experienced several adverse events. The most common reported in more than 25% of patients were dry mouth, diarrhea, hypertension, increased aspartate aminotransferase and a, peripheral edema, constipation, rash, headache, and fatigue. Of these 356 patients, 34 (9.6%) discontinued selpercatinib treatment due to adverse events, including 11 (3.1%) who experienced drug-related adverse events.

Disclosure: For full disclosures of the study authors, visit

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