Eli Lilly's Retevmo cuts recurrence risk 83% in early-stage RET-positive lung cancer trial

Eli Lilly announced Phase 3 LIBRETTO-432 results on June 1, 2026, evaluating Retevmo (selpercatinib) as adjuvant therapy in early-stage RET fusion-positive non-small cell lung cancer following definitive surgery. The trial demonstrated an 83% reduction in the risk of disease recurrence or death compared to placebo. This represents a substantial improvement over current adjuvant standards. The primary endpoint was disease-free survival. Safety profile remained consistent with prior Retevmo studies.

Retevmo holds FDA accelerated approval for metastatic RET-altered NSCLC and thyroid cancers. Phase 3 adjuvant data support a supplemental Biologics License Application (sBLA) for label expansion. Under 21 CFR 314.50, Lilly must submit full study reports, including LIBRETTO-432's primary analysis. The EMA's CHMP will require a type II variation to update the EU marketing authorization. Approval could shift post-surgical treatment for the 1-2% of NSCLC patients with RET fusions.

Lilly strengthens its position in the RET inhibitor market against Roche's Gavreto (pralsetinib), which lacks comparable adjuvant data. AstraZeneca's Tagrisso dominates the EGFR-mutant adjuvant NSCLC space, but Retevmo addresses an unmet need for RET fusion patients currently receiving chemotherapy or observation. Approximately 2,500 U.S. patients annually could become eligible for adjuvant Retevmo. Lilly has not yet announced a regulatory submission timeline.