FDA Approves Post-Chemoradiation Osimertinib for Advanced NSCLC

The FDA approved osimertinib (Tagrisso) for the treatment of adults with locally advanced, unresectable stage III non-small cell lung cancer (NSCLC) that did not progress during or after concurrent or sequential platinum-based chemoradiation therapy. The disease must also have EGFR exon 19 deletions or exon 21 L858R mutations, according to the agency.¹

The approval is based on findings from the double-blind LAURA trial (NCT03521154).² Patients were randomized 2:1 to receive either 80 mg of osimertinib daily or a placebo until disease progression or unacceptable toxicity.

Progression-free survival (PFS) assessed by blind independent central review served as the primary end points; the secondary end points was overall survival (OS).

Data from LAURA showed an improvement in PFS in the osimertinib group compared to the placebo group, reducing the risk for progression by 84% (HR, 0.16; 95% CI, 0.10-0.24; P < .001). Median PFS was 39.1 months (95% CI, 31.5-not estimable [NE]) and 5.6 months (95% CI, 3.7-7.4) in the osimertinib and placebo arms, respectively.

READ MORE: Osimertinib May Change Standard of Care for Stage III EGFR+ NSCLC After Definitive Chemoradiation

OS data were not yet mature at the time of the most recent study analysis, though no trend toward worsened survival with osimertinib was observed.

The most common adverse events from osimertinib—including laboratory abnormalities—that occurred in 20% or more of patients included lymphopenia, leukopenia, interstitial lung disease/pneumonitis, thrombocytopenia, neutropenia, rash, diarrhea, nail toxicity, musculoskeletal pain, cough, and COVID-19 infection.

References

1. FDA Release. FDA approves osimertinib for locally advanced, unresectable (stage III) non-small cell lung cancer following chemoradiation therapy. Published: September 25, 2024. Accessed: September 25, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-osimertinib-locally-advanced-unresectable-stage-iii-non-small-cell-lung-cancer?utm_medium=email&utm_source=govdelivery

2. Lu S, Kato T, Dong X, et al. Osimertinib after Chemoradiotherapy in Stage III EGFR-Mutated NSCLC. New Eng J Med. 2024;391:585-597. doi:10.1056/NEJMoa2402614.