Osimertinib (7) – Tagrisso®

• Clinical trials
  • The LAURA trial is an ongoing, double-blind, randomised, controlled trial comparing osimertinib with placebo.

a) Adults with locally advanced, inoperable NSCLC whose tumours harbour EGFR mutations in the form of a deletion in exon 19 or a substitution mutation in exon 21 (L858R), whose disease has not progressed during or after platinum-based chemoradiotherapy, and whose tumours express PD-L1 in ≥ 1% of tumour cells

• The additional benefit is not proven.
• The definition of the appropriate comparator therapy results in patient groups that differ depending on the patients’ PD-L1 status. However, PD-L1 status was not assessed in the LAURA study. Consequently, the study population cannot be assigned to patient groups a) and b).
• Overall, there are no suitable data available to assess the additional benefit of osimertinib for patient group a). The additional benefit is therefore not proven.

b) Adults with locally advanced, inoperable NSCLC whose tumours harbour EGFR mutations in the form of a deletion in exon 19 or a substitution mutation in exon 21 (L858R), whose disease has not progressed during or after platinum-based chemoradiotherapy, and whose tumours express PD-L1 in < 1 % of tumour cells

• The additional benefit is not proven.
• The definition of the appropriate comparator therapy results in patient groups that differ depending on the patients’ PD-L1 status. However, PD-L1 status was not assessed in the LAURA study. Consequently, the study population cannot be assigned to patient groups a) and b).
• Overall, there are no suitable data available to assess the additional benefit of osimertinib for patient group b). The additional benefit is therefore not proven.

Courtesy translation only, please refer to the German original.