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

Lilly reported Phase 3 LIBRETTO-432 data on selpercatinib as adjuvant therapy in stage IB-IIIA RET fusion-positive non-small cell lung cancer. The primary endpoint was independent review-assessed disease-free survival. Selpercatinib cut the risk of disease recurrence or death by 83% versus placebo. Full statistical data will be presented at an upcoming medical congress. This is the first Phase 3 targeted therapy confirmation in the RET-positive adjuvant setting.

Retevmo received accelerated FDA approval in May 2020 and conditional EMA authorization (EU brand: Retsevmo) in February 2021 for advanced RET-altered tumors. Lilly will file a supplemental NDA under 21 CFR 314.70 seeking adjuvant label expansion. FDA's Real-Time Oncology Review pathway may accelerate assessment. In Europe, Lilly must submit a Type II variation to the EMA under the centralized procedure. Standard EMA review requires 67 days for validation plus 210 days for assessment, though PRIME designation could shorten timelines.

Gavreto is the only other approved RET inhibitor but lacks Phase 3 adjuvant data. AstraZeneca's Tagrisso dominates EGFR-mutant adjuvant NSCLC but addresses a different patient population. The data positions Retevmo to capture the adjuvant RET-positive NSCLC segment, roughly 5-7% of lung cancer resections. Lilly plans regulatory submission by Q4 2026. Approximately 8,000-12,000 US and EU patients annually could become eligible for the new indication.