Lilly Moves Closer To NDA Filing For RET Inhibitor In NSCLC

Eli Lilly & Co.’s $8bn acquisition of Loxo Oncology Inc. in January is looking more like a win as selpercatinib (LOXO-292) posted Phase I/II data in RET fusion-positive non-small cell lung cancer (NSCLC) patients on 9 September that show strong, durable overall responses and progression-free survival as well as a very low rate of discontinuations due to treatment-related adverse events.

Lilly presented the latest data from the ongoing LIBRETTO-001 trial at the World Conference on Lung Cancer (WCLC) in Barcelona, from a cohort of heavily pretreated NSCLC patients whose tumors harbor abnormalities in the rearranged during transfection (RET) kinase. Selpercatinib is being developed as a potentially tissue-agnostic cancer therapy, but has breakthrough therapy designation for RET fusion-positive NSCLC and two types of RET-altered thyroid cancer US Food and Drug Administration