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Advanced NSCLCAugust 4, 2026

L858R with a TP53 co-mutation halved real-world PFS on front-line osimertinib

Patients with advanced EGFR-mutant non-small cell lung cancer who carried both an L858R mutation and a TP53 co-mutation had less than half the median real-world progression-free survival on front-line osimertinib of patients carrying neither, and less than half the median overall survival, according to an analysis of 606 patients from a United States clinical-genomic database published in Lung Cancer. The authors describe it as the largest study to date evaluating EGFR subtype combined with TP53 co-mutation status on survival endpoints with front-line osimertinib.
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In brief

  • In 606 patients with advanced EGFR-mutant NSCLC treated with front-line osimertinib, median real-world progression-free survival was 10.1 months in those carrying both EGFR L858R and a TP53 co-mutation, against 21.4 months in those with an exon 19 deletion and wild-type TP53 (hazard ratio 2.2, P less than 0.001).
  • Median overall survival in the same comparison was 21.3 months against 53.4 months (hazard ratio 2.3, P less than 0.001).
  • Each marker predicted worse outcomes on its own: L858R against exon 19 deletion gave hazard ratios of 1.4 for real-world progression-free survival and 1.3 for overall survival; a TP53 co-mutation against wild-type gave 1.5 and 1.6.
  • TP53 co-mutations were present in 384 patients (63%) and L858R in 277 (46%); 186 patients (30.7%) carried both.
  • The patients were studied from a United States clinical-genomic database rather than enrolled in a trial, and progression-free survival is a real-world endpoint.

Study at a glance

  • Cohort: 606 patients studied from a United States clinical-genomic database
  • Population: Advanced EGFR-mutant non-small cell lung cancer receiving front-line osimertinib
  • Marker frequencies: L858R in 277 (46%), TP53 co-mutation in 384 (63%), both in 186 (30.7%)
  • Endpoints: Real-world progression-free survival and overall survival, by Kaplan-Meier methods
  • Both markers against neither, PFS: Median 10.1 against 21.4 months (hazard ratio 2.2, P less than 0.001)
  • Both markers against neither, survival: Median 21.3 against 53.4 months (hazard ratio 2.3, P less than 0.001)
  • Adjustment: Multivariable Cox regression accounting for relevant clinical covariates
  • Not reported in the abstract: Confidence intervals for any hazard ratio, and which covariates entered the multivariable models

Median real-world progression-free survival of 10.1 months with both markers against 21.4 with neither

The two-marker comparison is the central result. Patients whose tumours carried EGFR L858R together with a TP53 co-mutation had a median real-world progression-free survival of 10.1 months on front-line osimertinib. Patients whose tumours carried an exon 19 deletion and wild-type TP53 had a median of 21.4 months. The hazard ratio was 2.2, with a P value below 0.001.

The size of the group makes the comparison worth reading closely. Of the 606 patients, 186 (30.7%) carried both unfavourable alterations, so the group with the shorter survival is close to a third of the cohort rather than a rare subgroup. The endpoint is real-world progression-free survival, and the abstract does not state how progression was ascertained.

Median overall survival of 21.3 months against 53.4 months in the same patients

Overall survival separated by a wider absolute margin than progression-free survival. Median overall survival was 21.3 months in patients with both markers and 53.4 months in patients with neither, a hazard ratio of 2.3 with a P value below 0.001. The difference of just over 32 months is larger than the whole median survival of the two-marker group.

An overall survival difference observed in a database cohort carries whatever treatment patients received after osimertinib as well as the markers being studied, and the abstract reports no subsequent-therapy data. What the figures establish is the survival of these patients as observed, not the share of it attributable to the markers themselves.

“Having EGFR L858R or a TP53 co-mutation were independent predictors of inferior rwPFS and OS with front-line osimertinib.”Kim et al., Lung Cancer (2026)

Hazard ratios of 1.4 and 1.5 for each marker taken on its own

Taken separately, L858R against exon 19 deletion gave a hazard ratio of 1.4 for real-world progression-free survival (P equal to 0.001) and 1.3 for overall survival (P equal to 0.01). A TP53 co-mutation against wild-type TP53 gave 1.5 for progression-free survival and 1.6 for overall survival, both with P values below 0.001.

Both associations held in multivariable Cox regression after accounting for clinical covariates, which is the basis on which the authors call them independent predictors. The abstract names neither the covariates included nor the confidence intervals around any of the four hazard ratios, so the precision of each estimate cannot be read from it.

A database cohort of 606 patients, with a real-world progression endpoint

Patients were studied from a United States clinical-genomic database rather than enrolled in a trial, and the endpoints were real-world progression-free survival and overall survival determined by Kaplan-Meier methods. TP53 co-mutations were present in 384 of the 606 patients, or 63%, which makes the TP53-wildtype group the smaller of the two throughout the comparisons above.

The authors propose the combination of the two markers as a way of identifying patients for novel trials or for approved intensified therapies. That is a proposal about trial design and treatment selection rather than a demonstration that intensified treatment helps these patients, and this study tested no intensified regimen.

Sources

  1. Lung Cancer. The impact of EGFR subtype combined with TP53 co-mutation status on survival outcomes with front-line osimertinib in non-small cell lung cancer (NSCLC) (2026-08-01). doi.org

Featuring Lung Summit faculty

This study was co-authored by Lung Summit faculty Hossein Borghaei.

This article was produced independently by the Lung Summit editorial team, without industry funding or input.

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