Osimertinib Recommended for EU Approval in Unresectable EGFR-Mutated NSCLC
Key Insights
The CHMP has recommended osimertinib (Tagrisso) for EU approval in adult patients with unresectable EGFR (search)-mutated non-small cell lung cancer (search) (NSCLC (search)).
The recommendation is based on the Phase III LAURA trial, which demonstrated a significant extension in median progression-free survival (PFS) to 39.1 months with osimertinib versus 5.6 months with placebo.
Osimertinib reduced the risk of disease progression or death by 84% compared to placebo, marking a potential new standard of care for this patient population.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of AstraZeneca's osimertinib (Tagrisso) for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (search) (NSCLC (search)) whose tumors have epidermal growth factor receptor (EGFR (search)) exon 19 deletions or exon 21 (L858R) substitution mutations, and whose disease has not progressed during or following platinum-based chemoradiation therapy (CRT). This decision is based on the pivotal LAURA Phase III trial results, which were published in The New England Journal of Medicine.
The LAURA trial demonstrated that osimertinib significantly extended median progression-free survival (PFS) to 39.1 months compared to 5.6 months with placebo (HR 0.16; 95% CI 0.10-0.24; p<0.001). This represents an 84% reduction in the risk of disease progression or death. The trial enrolled 216 patients across more than 145 centers in over 15 countries.
Clinical Impact and Expert Opinion
"The LAURA results build on the established efficacy of osimertinib and support the approval of the first targeted therapy for patients with unresectable, EGFR-mutated lung cancer (search)," said Manuel Cobo, MD, Specialist Physician of the Medical Oncology Service at the Carlos Haya University Hospital, Malaga, Spain, and investigator for the trial. "Today's positive recommendation marks an important step towards offering patients in Europe a targeted treatment option that can extend the time before their disease progresses by more than three years."
Osimertinib's Role in EGFR-Mutated NSCLC
Osimertinib is a third-generation, irreversible EGFR (search)-tyrosine kinase inhibitor (TKI) with proven clinical activity in NSCLC (search), including against central nervous system (CNS) metastases. It is already approved in more than 100 countries, including the US, EU, China, and Japan, for various indications in EGFR-mutated NSCLC, including first-line treatment, treatment of T790M mutation-positive NSCLC, and adjuvant treatment of early-stage disease. The drug is also approved in combination with chemotherapy in the US, China, and several other countries for first-line treatment of patients with locally advanced or metastatic EGFRm NSCLC.
Disease Burden and Unmet Need
Lung cancer is a significant global health challenge, with an estimated 2.4 million new diagnoses each year. It is the leading cause of cancer death, accounting for approximately one-fifth of all cancer-related deaths. Non-small cell lung cancer (search) (NSCLC (search)) is the most common form of lung cancer, and approximately 10-15% of NSCLC patients in the US and Europe, and 30-40% in Asia, have EGFR (search)-mutated NSCLC. For patients with unresectable Stage III EGFR-mutated NSCLC, there remains a critical need for effective targeted therapies.
Ongoing Research
AstraZeneca continues to investigate osimertinib in various settings, including neoadjuvant and adjuvant treatment, as well as in combination with other therapies to address mechanisms of resistance. Trials such as NeoADAURA, ADAURA2, SAVANNAH, ORCHARD, and SAFFRON are exploring new strategies to improve outcomes for patients with EGFR (search)-mutated NSCLC (search).