In this phase 3 trial of patients with early-stage RET fusion-positive NSCLC, adjuvant selpercatinib significantly improved 2-year event-free survival compared to placebo, reducing the risk of disease recurrence, progression, or death by approximately 83%. The treatment was associated with higher rates of liver enzyme elevations and treatment discontinuation compared to placebo.
Study
|
Phase 3, multinational, double-blind, randomized, placebo-controlled trial [LIBRETTO-432] |
| RET fusion-positive stage IB, II, or IIIA NSCLC after definitive therapy with curative intent |
| Adjuvant selpercatinib (N=75) vs placebo (N=76) for up to 3 years
|
Efficacy
|
2-yr EFS in stage II or IIIA: 92% vs 61% (HR 0.17 [0.06-0.51]) |
| 2-yr EFS in stage IB, II, or IIIA: 94% vs 70% (HR 0.16 [0.06-0.48])
|
Safety
|
Grade >=3 adverse events: increased alanine aminotransferase (17% vs 1%), hypertension (11% vs 3%) |
| Serious adverse events: 23% vs 13% |
| Adverse events leading to discontinuation: 17% vs 1%
|
N Engl J Med 2026; Published online May 31
http://doi.org/10.1056/NEJMoa2602628
Reviewed by Ulas D. Bayraktar, MD on Jun 14, 2026
