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 advancement in the treatment landscape for this patient population, addressing a critical unmet need.
The CHMP's positive opinion was primarily driven by the compelling 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, highlighting its potential to transform the standard of care.
Progression-Free Survival
The LAURA trial revealed a stark contrast in median progression-free survival (PFS) between the treatment arms. Patients treated with Tagrisso experienced a median PFS of 39.1 months, while those in the placebo arm had a median PFS of only 5.6 months. This substantial improvement underscores the clinical benefit of Tagrisso in delaying disease progression in this patient population. Although overall survival (OS) results are still maturing, the trial continues to evaluate OS as a secondary endpoint.
Safety Profile
The safety profile of Tagrisso in the LAURA trial was consistent with its known characteristics, and no new safety concerns were identified. This is an important consideration for clinicians when evaluating treatment options for their patients.
Industry Perspective
Susan Galbraith, Executive Vice-President, Oncology Research and Development, AstraZeneca, stated that the 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. She added that 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 follows recent approval in the US for a similar indication, with reviews also underway in countries including China and Japan based on the LAURA trial findings. AstraZeneca is also currently exploring the therapy in different clinical settings, such as 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.
