Eli Lilly Presents Data from LIBRETTO-001 Trial Evaluating Oral Selpercatinib for RET Fusion-Positive Non-Small Cell Lung Cancer


Eli Lilly presented data from the phase 1/2 trial, referred to as LIBRETTO-001, evaluating selpercatinib monotherapy, also known as LOXO-292, for the treatment of RET fusion-positive non-small cell lung cancer (NSCLC). These results were presented in the Presidential Symposium Session at the 2019 World Conference on Lung Cancer (WCLC) in Barcelona, Spain, hosted by the International Association for the Study of Lung Cancer (IASLC). 

LIBRETTO-001 was an open-label study evaluated selpercatinib administered orally to patients with advanced solid tumors, including RET-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation. The trial included a dose-escalation phase (Phase 1) and a dose-expansion phase (Phase 2). The Phase 2 portion of the trial had a primary endpoint of objective response rate (ORR) and secondary endpoints of the duration of response, progression-free survival, and safety. The primary analysis set for NSCLC regulatory submissions, as defined with the U.S. FDA, consists of the first 105 enrolled patients with RET fusion-positive non-small cell lung cancer who have experienced prior platinum-based chemotherapy. In the regist...

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