FLAURA2 Results Demonstrate Osimertinib Plus Chemotherapy Superior Compared to Osimertinib Alone

FLAURA2 Results Demonstrate Osimertinib Plus Chemotherapy Superior Compared to Osimertinib Alone

Press Release
Sep 10, 2023

­­Media Contact: Chris Martin, MPH, IASLC Media Relations, 630.670.2745, cmartin@davidjamesgroup.com 

[Singapore – 10:05 a.m. SGT--September 11, 2023] — Osimertinib plus chemotherapy demonstrated a statistically significant and clinically meaningful progression-free survival benefit compared to osimertinib alone, according to research presented today at the International Association for the Study of Lung Cancer (IASLC) 2023 World Conference on Lung Cancer in Singapore.

The FLAURA2 study was led by Dr. Pasi A. Jänne from the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute in Boston, Mass.

Osimertinib, a potent third-generation EGFR-TKI with central nervous system activity, has garnered attention for its targeted inhibition of both sensitizing and resistance EGFR mutations. According to Dr. Jänne, The FLAURA2 trial builds on the favorable results observed in the phase III FLAURA trial, where osimertinib displayed superiority over comparator EGFR-TKIs.

The study enrolled 557 patients and randomized them 1:1 into two treatment arms: osimertinib plus chemotherapy or osimertinib monotherapy. The combination arm involved a regimen of osimertinib (80 mg daily) alongside pemetrexed and either cisplatin or carboplatin. 

“Results from the study demonstrated a remarkable improvement in progression-free survival (PFS) with the osimertinib plus chemotherapy approach, showcasing a statistically significant reduction in disease progression risk compared to osimertinib monotherapy,” Dr. Jänne said.

The data showed a compelling hazard ratio of 0.62 (95% CI 0.49, 0.79; p<0.0001) for progression-free survival, signifying an 8.8-month enhancement in median progression-free survival. Moreover, the objective response rate per investigator was notably higher in the combination arm at 83%, compared to 76% in the osimertinib monotherapy group. Safety analyses revealed that the combination therapy was generally well-tolerated, with manageable adverse events.

“These findings mark a significant advancement in the management of advanced EGFR-mutated NSCLC,” Dr. Jänne reported. “The FLAURA2 study supports osimertinib combined with platinum-pemetrexed chemotherapy as a new and promising first-line treatment option, poised to make a profound impact on patient outcomes in this challenging disease setting.”



The International Association for the Study of Lung Cancer (IASLC) is the only global organization dedicated solely to the study of lung cancer and other thoracic malignancies. Founded in 1974, the association's membership includes more than 8,000 lung cancer specialists across all disciplines in over 100 countries, forming a global network working together to conquer lung and thoracic cancers worldwide. The association also publishes the Journal of Thoracic Oncology, the primary educational and informational publication for topics relevant to the prevention, detection, diagnosis, and treatment of all thoracic malignancies. Visit http://www.iaslc.org for more information. 

About the WCLC:

The WCLC is the world’s largest meeting dedicated to lung cancer and other thoracic malignancies, attracting more than 7,000 researchers, physicians, and specialists from more than 100 countries. The goal is to increase awareness, collaboration, and understanding of lung cancer, and to help participants implement the latest developments across the globe. The conference will cover a wide range of disciplines and unveil several research studies and clinical trial results. For more information, visit https://wclc2023.iaslc.org