Abstract CT160: Safety of selpercatinib for RET-altered advanced solid tumors: a post hoc analysis of LIBRETTO-001

Introduction: Selpercatinib, approved by FDA in May 2020 is a highly selective and potent RET inhibitor which has demonstrated antitumor activity in patients (pts) with RET-altered non-small-cell lung cancer and thyroid cancer. To further characterize clinical safety, we analyzed the timing of selected treatment-emergent adverse events (TEAEs) as well as long-term use of selpercatinib. Methods: Pts with RET-fusion positive or RET-mutant tumors who received at least 1 dose of selpercatinib, as part of the LIBRETTO-001 study, were included in this analysis (data-cut off 19 Dec 2019; NCT 03157128). Median time to onset, dose reduction, and discontinuation due to TEAEs were evaluated for relevant common TEAEs (≥25% of pts) and TEAEs of special interest. TEAE data were also analyzed according to time exposed to treatment at cutoff ( Citation Format: Todd M Bauer, Benjamin Besse, Herbert H F Loong, Bruce Robinson, Victoria Soldatenkova, Catherine Elizabeth Muehlenbein, Bente Frimodt-Moller, Caroline E McCoach. Safety of selpercatinib for RET-altered advanced solid tumors: a post hoc analysis of LIBRETTO-001 [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2021; 2021 Apr 10-15 and May 17-21. Philadelphia (PA): AACR; Cancer Res 2021;81(13_Suppl):Abstract nr CT160.