The Committee for Medicinal Products for Human Use (CHMP) has recommended Tagrisso (osimertinib) for approval in the European Union for patients with unresectable Stage III EGFR-mutated non-small cell lung cancer (NSCLC) whose disease has not progressed following definitive platinum-based chemoradiotherapy (CRT). This decision marks a significant step forward in addressing the needs of this patient population.
The recommendation is based on the Phase III LAURA trial, a randomized, double-blind, placebo-controlled study. The trial evaluated Tagrisso (80mg once-daily oral tablets) in patients with unresectable Stage III EGFR-mutated NSCLC who had not progressed after platinum-based CRT. The primary endpoint of the trial was progression-free survival (PFS).
The LAURA trial enrolled 216 patients across more than 145 centers in over 15 countries, including the US, Europe, South America, and Asia. Patients in the placebo arm were offered Tagrisso upon disease progression. The trial is ongoing and continues to assess the secondary endpoint of overall survival (OS).
Clinical Significance of Tagrisso
Tagrisso (osimertinib) is a third-generation, irreversible EGFR-tyrosine kinase inhibitor (TKI) with proven clinical activity in NSCLC, including against central nervous system (CNS) metastases. It functions by blocking the cell-signaling pathways that drive the growth of tumor cells. AstraZeneca continues to explore Tagrisso as a treatment for patients across multiple stages of EGFR-mutated NSCLC.
Tagrisso has demonstrated improved patient outcomes in early-stage disease (ADAURA Phase III trial), Stage III unresectable disease (LAURA Phase III trial), and late-stage disease (FLAURA Phase III trial), as well as in combination with chemotherapy (FLAURA2 Phase III trial).
Lung Cancer Context
Lung cancer is a major global health concern, with an estimated 2.4 million new diagnoses each year. It is the leading cause of cancer death among both men and women, accounting for approximately one-fifth of all cancer deaths. NSCLC is the predominant form of lung cancer, and a significant proportion of NSCLC patients (10-15% in the US and Europe, 30-40% in Asia) have EGFR mutations, making them particularly sensitive to EGFR-TKI treatment.
AstraZeneca is also investigating Tagrisso in the neoadjuvant setting (NeoADAURA Phase III trial) and in the early-stage adjuvant resectable setting (ADAURA2 Phase III trial). The company is also researching ways to address tumor mechanisms of resistance through the SAVANNAH and ORCHARD Phase II trials, and the SAFFRON Phase III trial, which test Tagrisso plus savolitinib as well as other potential new medicines.
