Eli Lilly said its oral RET inhibitor Retevmo (selpercatinib) significantly improved event-free survival (EFS) vs placebo as adjuvant therapy in 151 patients with early-stage, RET fusion-positive Non-Small Cell Lung Cancer (NSCLC) in the phase 3 LIBRETTO-432 trial. Overall survival trended in favor of Retevmo, but the analysis was immature with few events.
Why It Matters To Oncology
Adjuvant targeted therapy continues to move earlier in lung cancer care; LIBRETTO-432 adds RET fusions to the growing list (after EGFR and ALK) where molecular selection may change post-curative-intent management.
The readout strengthens the clinical argument for broad genomic testing in early-stage NSCLC to avoid missing rare but actionable drivers like RET fusions.
For drug discovery, it reinforces a development template: validate a driver in metastatic disease, then expand into minimal residual disease settings where effect sizes can be most compelling.
The Financials
Lilly did not disclose EFS hazard ratio, absolute EFS rates, or a revenue impact in the announcement; commercial implications hinge on the magnitude/durability of EFS benefit and label expansion timing.
Earlier-stage adoption could expand the treatable population beyond the currently approved locally advanced/metastatic RET fusion-positive NSCLC setting—conditional on regulatory outcomes and testing uptake.
Near-term value inflection is tied to full data presentation at a medical congress and subsequent regulator discussions.
What They're Saying
Jacob Van Naarden, president of Lilly Oncology: “We have consistently observed that cancer medicines can deliver their greatest impact when administered early…” and said the effect size is “in line with the most striking data for targeted adjuvant therapy in lung cancer.”
Van Naarden added the company hopes the results “further accelerate the use of genomic testing for all people diagnosed with early-stage disease.”
Lilly said safety was generally consistent with earlier selpercatinib trials.
What's Next
Watch for the full LIBRETTO-432 dataset (EFS hazard ratio, subgroup consistency, duration of therapy, discontinuation rates, CNS outcomes if reported) when presented at an upcoming medical congress.
Regulatory discussions will clarify whether EFS is sufficient for an adjuvant label expansion and what postmarketing/OS follow-up may be required.
Clinically, adoption will depend on operationalizing early-stage RET fusion testing (tissue vs plasma, turnaround time, and reflex testing pathways after surgery/RT).