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Eli Lilly's Retevmo Phase 3 LIBRETTO-432 Cuts Recurrence Risk 83% In RET+ Early-Stage NSCLC

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us

Eli Lilly and Co. (LLY) announced results from the Phase 3 LIBRETTO-432 clinical trial of Retevmo (selpercatinib) as adjuvant therapy versus placebo in patients with early-stage (IB-IIIA) RET fusion-positive non-small cell lung cancer (NSCLC). The study met its primary endpoint, showing a highly statistically significant and clinically meaningful improvement in investigator-assessed event-free survival (EFS). Selpercatinib reduced the risk of disease recurrence or death by 83% compared to placebo in the primary analysis population.

At a median follow-up of 24 months, investigator-assessed EFS in the primary analysis population (patients with stage II-IIIA disease, n=109) was significantly improved with selpercatinib. The 24-month EFS rate was 92% for selpercatinib versus 61% for placebo. Median EFS was not reached in the selpercatinib group, compared to 31.8 months for placebo. In the overall study population (patients with stage IB-IIIA disease, n=151), results were consistent, with a 24-month EFS rate of 94% for selpercatinib and 70% [95% CI, 55.5-80.1] for placebo. Findings were aligned across blinded independent central review and key subgroups in both the primary and overall populations. Overall survival results trended in favor of selpercatinib, though data were immature at the time of analysis with few events observed.

The safety profile of selpercatinib in LIBRETTO-432 was generally consistent with prior trials in its development program. The most common Grade 3 or higher adverse events were increased alanine aminotransferase (ALT) (17% vs. 1% with placebo) and increased aspartate aminotransferase (AST) (19% vs. 3% with placebo). These events were manageable with dose modifications, supporting the overall tolerability of selpercatinib in this setting.

LLY closed at $1,105.00, down $21.80 or 1.93% on May 29 at 4:04:50 PM EDT. In after-hours trading, the stock slipped slightly further to $1,103.63, down $1.38 or 0.12%.

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