The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended AstraZeneca's Tagrisso (osimertinib) for approval in the European Union (EU) for the treatment of individuals with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose tumors have specific epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, following no disease progression post-platinum-based chemoradiation therapy (CRT). This decision marks a significant step forward in addressing the unmet needs of patients with this challenging form of lung cancer.
The CHMP's positive opinion was primarily based on the outcomes from the Phase III LAURA study. The study demonstrated that Tagrisso significantly reduced the risk of disease progression or death by 84% compared to placebo. This substantial improvement highlights the potential of Tagrisso to transform the treatment landscape for patients with EGFR-mutated NSCLC.
Progression-Free Survival
In the LAURA trial, patients treated with Tagrisso achieved a median progression-free survival (PFS) of 39.1 months, a stark contrast to the 5.6 months observed in the placebo arm. This marked difference underscores the clinical benefit of Tagrisso in delaying disease progression in this patient population. While overall survival (OS) results are still maturing, the trial continues to monitor OS as a secondary endpoint to further evaluate the long-term benefits of Tagrisso.
Safety Profile
The safety profile of Tagrisso in the LAURA trial was consistent with its established characteristics, and no new safety concerns were identified. This is an important consideration for clinicians when evaluating treatment options for their patients.
Expert Commentary
Susan Galbraith, Executive Vice-President of Oncology Research and Development at AstraZeneca, noted, “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.”
Regulatory Landscape and Ongoing Research
Tagrisso's application for approval in the EU follows its recent approval in the US for a similar indication. Reviews are also underway in other countries, including China and Japan, based on the findings of the LAURA trial. AstraZeneca is also exploring the therapy in different clinical settings, such as the neoadjuvant setting in the NeoADAURA Phase III trial and the early-stage adjuvant resectable 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, further expanding its potential applications.
