Eli Lilly’s Retevmo Cuts Recurrence Risk by 83% in Early-Stage Lung Cancer
LLY•Phase 3 LIBRETTO-432 trial showed Retevmo reduced recurrence or death risk by 83% versus placebo in 151 early-stage RET fusion-positive NSCLC patients. At two years, event-free survival reached 92% with selpercatinib versus 61% on placebo, with manageable Grade 3+ liver enzyme elevations in 17–19% of treated patients.
1. Trial Design and Enrollment
The Phase 3 LIBRETTO-432 trial enrolled 151 patients with stage IB–IIIA RET fusion-positive non-small cell lung cancer after surgery or radiation. Participants were randomized to receive selpercatinib 160 mg twice daily or placebo for up to three years to assess adjuvant therapy benefit.
2. Efficacy Outcomes
In the primary analysis of 109 stage II–IIIA patients, selpercatinib treatment reduced the risk of recurrence or death by 83% versus placebo (hazard ratio 0.17). After a median 24-month follow-up, two-year event-free survival was 92% with selpercatinib compared to 61% on placebo, and median event-free survival remains unreached for the treatment arm.
3. Safety Profile
Grade 3 or higher adverse events were primarily elevations in liver enzymes, with alanine aminotransferase increases in 17% and aspartate aminotransferase in 19% of selpercatinib patients versus 1% and 3% in the placebo group. These side effects were managed through dose modifications without new safety signals.
4. Next Steps
Eli Lilly plans to submit these data for regulatory review to expand Retevmo’s label as an adjuvant therapy in RET fusion-positive NSCLC. The company will also present findings at the ASCO Annual Meeting and pursue publication in a peer-reviewed journal.
