First and only EGFR inhibitor and targeted treatment to show benefit in stage III setting, extending progression-free survival by more than three years
Positive results from the LAURA Phase III trial showed AstraZeneca’s TAGRISSO (osimertinib) demonstrated a statistically significant improvement in progression-free survival (PFS) for patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose tumours have exon 19 deletions or exon 21 (L858R) mutations, after chemoradiotherapy (CRT) compared to placebo after CRT.
These results will be presented today during the Plenary Session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (abstract #LBA4) and simultaneously published in The New England Journal of Medicine.
Results showed TAGRISSO reduced the risk of disease progression or death by 84 per cent compared to placebo (hazard ratio
0.16; 95 per cent confidence interval [CI] 0.10-0.24; p<0.001) as assessed by blinded independent central review (BICR). Median PFS was 39.1 months in patients treated with TAGRISSO versus 5.6 months for placebo.
The statement informs, “Importantly, a clinically meaningful PFS benefit was observed across all prespecified subgroups including sex, race, type of EGFR mutation, age, smoking history, and prior CRT.”
Overall survival (OS) data showed a favourable trend for TAGRISSO, although data were not mature at the time of this analysis. The trial will continue to assess OS as a secondary endpoint.
Summary of results: LAURA
| TAGRISSO | Placebo | |
| Median PFS (in months)i | 39.1 (31.5, NC)ii | 5.6 (3.7, 7.4) |
| Hazard ratio (95 per cent CI) | 0.16 (0.10, 0.24) | |
| p-value | <0.001iii | |
| Data maturity | 56 per cent | |
| 40 per cent | 86 per cent | |
| i. Data cut-off date was January 5, 2024. |
ii. NC: Not calculable
iii. Nominal p-value
Safety results and discontinuation rates due to adverse events (AEs) were as expected and no new safety concerns were identified. Grade 3 or higher AEs from all causes occurred in 35 per cent of patients in the TAGRISSO arm versus 12 per cent in the placebo arm.
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