Results from a prespecified exploratory analysis of the positive ADAURA Phase III trial showed AstraZeneca’s (NYSE:AZN) TAGRISSO (osimertinib) demonstrated a clinically meaningful improvement in central nervous system (CNS) disease-free survival (DFS) in the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC), after complete tumor resection.
This analysis showed that fewer patients treated with TAGRISSO in the adjuvant setting had recurrence events or deaths compared to placebo (11% versus 46%).
Among patients whose cancer recurred, 38% of those treated with TAGRISSO had a metastatic recurrence compared to 61% of patients on placebo.
TAGRISSO showed an 82% reduction in the risk of CNS recurrence or death (based on a hazard ratio [HR] of 0.18; 95% confidence interval [CI] 0.10-0.33; p<0.0001). Median CNS DFS was not yet reached in either arm.
In a post-hoc analysis, the estimated probability of observing disease recurrence in the brain at 18 months for patients treated with TAGRISSO was less than 1% versus 9% for placebo.
On the primary endpoint of DFS in patients with Stage II and IIIA disease, TAGRISSO in the adjuvant setting reduced the risk of disease recurrence or death by 83% (HR 0.17; 95% CI 0.12-0.23; p<0.0001).
The safety and tolerability of TAGRISSO in this trial was consistent with previous trials in the metastatic EGFRm NSCLC setting. Adverse events at Grade 3 or higher from all causes occurred in 10% of patients in the TAGRISSO arm versus 3% in the placebo arm as assessed by investigators.
Results were presented at the ESMO Virtual Congress 2020 and published in The New England Journal of Medicine.
The data readout was originally anticipated in 2022. The trial will continue to assess OS.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.