Eli Lilly Retevmo Phase III Trial: 83% Reduction in Recurrence or Death Risk for Early-Stage Lung Cancer
Claire Weston
Eli Lilly's targeted therapy Retevmo cut the risk of recurrence or death by 83% in early-stage lung cancer patients after surgery — the first Phase III adjuvant data for RET fusion-positive NSCLC, a result that could rewrite standard of care for these patients.
What was this trial actually testing?
Retevmo (selpercatinib) is already approved for advanced RET fusion-positive lung cancer. This trial asked a different question: can it prevent recurrence when given after surgery or radiation in early-stage patients?
The trial, LIBRETTO-432, enrolled 151 patients globally with stage IB–IIIA disease, randomized to selpercatinib or placebo for up to three years.
In plain terms = the drug already works when cancer has spread; now Lilly is proving it works *before* it spreads.
How strong are the numbers?
Among stage II–IIIA patients, the Retevmo group had a 24-month event-free survival rate of 92%, versus 61% for placebo — a gap of over 30 percentage points.
Median event-free survival in the treatment arm has not been reached; in the placebo arm it was 31.8 months. This means → most patients on the drug still hadn't relapsed by the data cutoff — the statisticians couldn't even calculate a midpoint.
Including stage IB patients, the 24-month rates were 94% versus 70%, still a significant benefit.
Are there safety concerns?
The most common serious adverse event was elevated liver enzymes (ALT and AST). Lilly said this is manageable through dose adjustment.
The overall safety profile was consistent with prior studies in advanced patients — no new signals emerged.
In plain terms = the side effects center on liver markers, are known, controllable, and not a new risk.
What does this mean for patients and the industry?
UCLA clinical trial director Jonathan Goldman said the results could change treatment practice for RET-positive lung cancer, and stressed the importance of genomic testing at diagnosis.
This reflects a broader precision-oncology trend: test the genes first, then choose the drug — rather than routing all early-stage lung cancer patients down the same path.
Lilly plans to submit the data to regulators worldwide for an adjuvant-therapy indication. This means → if approved, Retevmo's addressable patient pool expands from late-stage to early-stage, widening its commercial reach.
These results could influence treatment practice for RET-positive lung cancer patients and underscore the importance of genomic testing at diagnosis.
Jonathan Goldman
Director of Clinical Trials, UCLA
(ASCO Annual Meeting presentation)
Content is for reference only, not financial advice.