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. Pasi A. Jänne, Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute
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."