The 10th anniversary of 'Tagrisso' approval in Korea

"Transforming the landscape of lung cancer treatment"

All-cycle management strategy for treating EGFR-mutated lung cancer is expanding

Adjuvant therapies to combination therapies…clinical evidence accumulates

As the therapeutic landscape for EGFR-mutated non-small cell lung cancer (NSCLC) shifts toward all-cycle management from early to metastatic stages, AstraZeneca’s 'Tagrisso (osimertinib)' is recognized as a key driver of treatment strategy changes, based on clinical evidence accumulated over the past decade.

Industry analysis suggests that by securing clinical data demonstrating not only progression-free survival (PFS) but also overall survival (OS) improvements and reduced post-operative recurrence, the treatment paradigm for EGFR-mutated lung cancer is transitioning from a life-extension focus to expanding curability.

Se Hoon Lee, Professor of Hematology-Oncology at Samsung Medical Center

On May 19, AstraZeneca Korea hosted a press conference at the Plaza Hotel in Jung-gu, Seoul, to commemorate the 10th anniversary of Tagrisso’s approval in South Korea, sharing major global clinical trial outcomes and the future direction of its treatment strategies.

Tagrisso was first approved in South Korea in May 2016 as a second-line therapy for patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. This drug received an expanded indication for first-line monotherapy in 2018. In 2021, Tagrisso became the only EGFR tyrosine kinase inhibitor (EGFR-TKI) to secure an indication for adjuvant therapy following complete surgical resection.

Furthermore, its indication for combination use with platinum-based chemotherapy, broadening its therapeutic scope in 2024 by

Currently, Tagrisso is the only third-generation EGFR-TKI recommended as a "Preferred" Category 1 option by the National Comprehensive Cancer Network (NCCN) guidelines for both first-line monotherapy and combination chemotherapy regimens. Its application as a post-operative adjuvant therapy also holds a Category 1 recommendation.

Se Hoon Lee, Professor of Hematology-Oncology at Samsung Medical Center, said, "The lung cancer targeted therapy paradigm has evolved most rapidly  for the EGFR mutation," and added, "With a high prevalence of these mutations among Korean patients and subsequent improvements in survival rates driven by targeted therapies, the outpatient landscape for long-term patient management has fundamentally transformed."

Professor Lee added, "The advancement of EGFR-TKIs, including those for Tagrisso, established the benchmark for developing subsequent mutation-targeted strategies in ALK, ROS1, and KRAS." Professor Lee said,  "Progression beyond treating metastatic disease to a stage where we aim for a cure in Stage I and II patients is highly meaningful."

Ji Yoon Lee, AstraZeneca Korea's Medical Affairs Unit Director

Indeed, Tagrisso has built clinical evidence across various stages of the disease through major global clinical trials, including FLAURA, FLAURA2, ADAURA, LAURA, and AURA3.

In the FLAURA study, Tagrisso became the standard of care by demonstrating both overall survival (OS) and progression-free survival (PFS) benefits in the first-line treatment of advanced NSCLC positive for EGFR Exon 19 deletions or Exon 21 (L858R) mutations.

After that, in the FLAURA2 study, the final analysis of Tagrisso combined with platinum-based chemotherapy demonstrated a median OS of 47.5 months. Experts highlighted that the combination also showed a trend toward a reduced risk of death in patients with central nervous system (CNS) metastases compared to the control group.

In the ADAURA study, which evaluated post-operative adjuvant therapy, the analysis of the overall patient population with Stages IB to IIIA disease demonstrated a 73% reduction in the risk of disease recurrence or death compared with the control group, highlighting its potential to expand into early-stage treatment.

Additionally, the LAURA study reported a statistically significant prolongation of progression-free survival in patients with unresectable Stage III disease, extending the drug's targeted strategy into the locally advanced setting.

Ji Yoon Lee, AstraZeneca Korea's Medical Affairs Unit Director, said, "Over the past 10 years, Tagrisso has continuously accumulated core clinical evidence within the global and domestic EGFR-mutated NSCLC treatment landscape," and added, "We will continue our research and development efforts to advance tailored treatment strategies optimized for specific patient characteristics and disease stages."

Hyun Ju Lee, AstraZeneca Korea's Oncology Business Unit director, stated, "The 10th anniversary of Tagrisso’s approval in South Korea represents the shifting paradigm of EGFR-mutated lung cancer care. Based on our oncology R&D capabilities and leadership, we will continue to contribute to improving a patient-centric treatment environment."