Skip to content

LIBRETTO-432 — Adjuvant selpercatinib, stage IB–IIIA RET fusion+ NSCLC

Abstract: LBA3 · Session: Plenary, Sun May 31, 2026, Hall B1 · Embargo: lifted 7:00 AM CT May 31

At a glance

  • Sponsor: Eli Lilly (Loxo@Lilly)
  • NCT ID: NCT04819100
  • Phase: 3
  • Design: Randomized, double-blind, placebo-controlled; adjuvant selpercatinib vs placebo after definitive treatment (resection ± chemo/radiation)
  • Primary endpoint(s): EFS (event-free survival) — met
  • Comparator: placebo
  • Indication: stage IB–IIIA RET fusion-positive NSCLC
  • Line: adjuvant

Headline result

Adjuvant selpercatinib cut the risk of recurrence or death by 83% vs placebo (EFS), a large and statistically significant benefit. No adjuvant RET-directed targeted therapy had previously been approved in this subset — LIBRETTO-432 establishes a potential new standard of care.

Mechanism / class

Selpercatinib (Retevmo) is a selective RET kinase inhibitor. LIBRETTO-432 extends RET-TKI use from advanced disease into the curative-intent adjuvant setting, mirroring ADAURA (osimertinib, EGFR) and ALINA (alectinib, ALK).

Discussant takeaway

The adjuvant-lung discussion focused on the familiar EFS-vs-OS and "treat-now vs at-recurrence" question for oncogene-addicted adjuvant TKIs, and on optimal duration — but the 83% EFS reduction was treated as practice-defining for RET+ resected disease.

Practice-changing?

Likely yes — first adjuvant RET TKI; slots into the molecular-adjuvant paradigm alongside osimertinib and alectinib.

  • Other ASCO 2026 trials: ALCHEMIST EA5142 (adjuvant nivolumab), CROWN 7-yr (ALK+) — the adjuvant/perioperative lung cluster.
  • JPM 2026: Lilly (Retevmo/Verzenio) on the JPM stage.
  • Theme: targeted therapy moving earlier in disease (perioperative/adjuvant).

Sources