FP14.05 LIBRETTO-431: Selpercatinib in Treatment-Naïve Patients with RET Fusion-Positive Non-Small Cell Lung Cancer (NSCLC).

Selpercatinib (LOXO-292) is a highly selective and potent inhibitor of RET signaling. In the LIBRETTO-001 Phase I/II trial, selpercatinib treatment resulted in 64% objective response rate (ORR) (95% confidence interval [CI]: 54-73%) registration dataset (n=105) patients with RET+ NSCLC who previously received platinum-based chemotherapy an 85% ORR CI: 70-94%) treatment-naïve (n=39). Although duration (DOR) progression free-survival (PFS) were not yet mature patients, chemotherapy, median DOR was 18 months 12-not estimable [NE]), PFS 17.5 12-NE), CNS per RECIST 1.1 91% 59-100%) (n=10/11).