Lilly could broaden its Retevmo reach

Lilly’s RET inhibitor Retevmo was FDA approved several years ago for first-line and later RET-fusion-positive lung cancer, and now Lilly hopes to broaden into adjuvant disease, after toplining a win in the Libretto-432 trial on Monday. The study is evaluating Retevmo versus chemo in stage II-IIIA disease following radiotherapy or surgery. Lilly is holding back full results for a medical meeting, but said the trial met its primary endpoint of event-free survival. However, one reason for caution is the fact the company could only point to a trend towards improvement in overall survival with Retevmo, although OS data are immature. The drug got an accelerated nod for metastatic RET fusion-positive NSCLC in 2020, and full approval followed in 2022, both based on the phase 1/2 Libretto-001 study. RET fusions have been identified in 1-2% of all NSCLC cases, according to Lilly. The company didn’t split out 2025 sales for Retevmo, which came via its $8bn purchase of Loxo in 2019.

Retevmo in RET fusion-positive NSCLC

Source: OncologyPipeline & company announcement.