Eli Lilly's Retevmo achieves 83% recurrence risk reduction in early-stage RET fusion lung cancer

Lilly reported Phase 3 LIBRETTO-432 data showing Retevmo as adjuvant therapy cut disease recurrence or death risk by 83% versus placebo in early-stage RET fusion-positive non-small cell lung cancer. The trial met its primary endpoint of disease-free survival with overwhelming efficacy. Investigators halted the study after a planned interim analysis crossed the prespecified efficacy boundary. The 83% hazard reduction represents one of the largest adjuvant benefits recorded in a molecularly defined NSCLC subset.

Retevmo holds FDA accelerated approval for RET-altered NSCLC and thyroid cancers under Project Orbis. The LIBRETTO-432 data supports a label expansion filing under 21 CFR 314.70 for the adjuvant indication. EMA's CHMP previously granted selpercatinib a positive opinion for advanced RET fusion-positive tumors. Lilly must submit a Type II Variation to EMA within six months to extend the adjuvant indication. FDA's Oncologic Drug Advisory Committee may convene to review the magnitude of benefit.

Retevmo's adjuvant dominance pressures Blueprint Medicines' Gavreto in the RET inhibitor space. AstraZeneca's pipeline RET-targeting agents face a higher efficacy bar. The June 1, 2026 readout positions Lilly for a Q4 2026 supplemental NDA submission. Oncologists may soon test all early-stage NSCLC tumors for RET fusions at diagnosis. The data could establish RET testing as standard alongside EGFR and ALK screening.