Lilly: Retevmo reduces recurrence/death risk by 83% as adjuvant in early‑stage RET‑fusion NSCLC

Trial design

LIBRETTO-432 was a global, randomized, double-blind Phase 3 study enrolling 151 patients with stage IB–IIIA RET‑fusion NSCLC, randomized 1:1 to selpercatinib 160 mg twice daily or placebo for up to three years after definitive surgery or radiotherapy (with or without adjuvant chemotherapy); the primary analysis population was patients with stage II–IIIA (n=109) and the primary endpoint was investigator‑assessed event‑free survival (EFS).

Efficacy results

At a median follow‑up of 24 months the primary analysis showed a significant EFS benefit for selpercatinib (HR 0.17; 95% CI 0.06–0.51; p<0.001); 24‑month EFS was 92% with selpercatinib versus 61% with placebo and median EFS was not reached versus 31.8 months for placebo; results were consistent in the overall IB–IIIA population (HR 0.17; 95% CI 0.06–0.49) and across blinded independent central review and key subgroups; overall survival data were immature.

Safety

The safety profile in LIBRETTO‑432 was consistent with prior selpercatinib studies; the most common Grade ≥3 laboratory adverse events were increased ALT (17% selpercatinib vs 1% placebo) and increased AST (19% vs 3%), generally manageable with dose modification.

Publication and regulatory plans

Results will be published in the New England Journal of Medicine and presented in the Plenary Session at the 2026 ASCO Annual Meeting; Lilly plans to submit LIBRETTO‑432 data to global health authorities.