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Benjamin Besse, MD, discusses the results of an ad-hoc safety analysis of the phase 1/2 LIBRETTO-001 trial, which examined the use of selpercatinib in patients with RET-altered advanced medullary thyroid cancer and non–small cell lung cancer.
Benjamin Besse, MD, head of the Department of Cancer Medicine at Institut Gustave Roussy, discusses the results of an ad-hoc safety analysis of the phase 1/2 LIBRETTO-001 trial (NCT03157128), which examined the use of selpercatinib (Retevmo) in patients with RET-altered advanced medullary thyroid cancer and non–small cell lung cancer (NSCLC).
Most of the adverse effects (AEs) associated with selpercatinib are manageable, according to Besse. At the 2021 AACR Annual Meeting, updated data on the toxicities experienced by patients who received treatment with selpercatinib were presented. In total, 702 patients were enrolled to the trial, a majority of whom had NSCLC or medullary thyroid cancer.
AEs were found to be dose dependent, with patients experiencing any grade of dry mouth (38.9%), diarrhea (36.6%), hypertension (35.9%), fatigue (35.0%), edema (34.5%), and liver toxicities (Aspartate aminotransferase increase, 29.9%; Alanine transaminase increase, 28.6%). However, 6.9% of patients discontinued after less than 12 months of treatment with selpercatinib and 2.1% discontinued after 12 months or more because of treatment emergent AEs, Besse notes. Additionally, reducing the dose of the agent helped decrease toxicities in this patient population, Besse concludes.