The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for AstraZeneca's Tagrisso (osimertinib) for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in the European Union (EU). This decision targets patients whose tumors harbor specific epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, and who have not experienced disease progression following platinum-based chemoradiation therapy (CRT).
The CHMP's recommendation stems from the Phase III LAURA study, a pivotal trial demonstrating a significant improvement in progression-free survival (PFS) with Tagrisso. The study revealed that Tagrisso reduced the risk of disease progression or death by 84% compared to placebo. Median PFS in patients treated with Tagrisso was 39.1 months, a stark contrast to the 5.6 months observed in the placebo arm. While overall survival (OS) data are still maturing, OS continues to be evaluated as a secondary endpoint in the trial.
Clinical Impact and Safety Profile
The LAURA trial's findings underscore Tagrisso's potential to address a critical unmet need in the treatment of EGFR-mutated NSCLC. The observed median PFS of 39.1 months represents a substantial improvement over existing treatment options for this patient population. Furthermore, the safety profile of Tagrisso in the LAURA trial was consistent with its established safety characteristics, with no new safety concerns identified.
Expert Commentary
According to Susan Galbraith, Executive Vice-President of Oncology Research and Development at AstraZeneca, "Today’s news reinforces Tagrisso as the backbone therapy in EGFR-mutated non-small cell lung cancer, meeting the critical unmet need for an effective targeted treatment option in the unresectable setting. Tagrisso has now demonstrated its benefit across all stages of EGFR-mutated lung cancer, representing a pivotal step in transforming care for patients who are urgently in need of innovative therapies that can help extend their lives."
Broader Applications and Ongoing Studies
Tagrisso's application for this indication follows its recent approval in the US for a similar patient population. Reviews are also underway in other countries, including China and Japan, based on the LAURA trial data. AstraZeneca is further investigating Tagrisso in various clinical settings, including the neoadjuvant setting in the NeoADAURA Phase III trial and the early-stage adjuvant resectable setting in the Phase III ADAURA2 trial. In June 2024, the Japanese Pharmaceuticals and Medical Device Agency approved Tagrisso (osimertinib) plus chemotherapy as a first-line treatment for adults with NSCLC.
