Osimertinib plus chemotherapy may have demonstrated a statistically significant and clinically meaningful progression-free survival benefit in patients with advanced non–small cell lung cancer (NSCLC) compared with osimertinib alone, according to new findings presented by Jänne et al at the International Association for the Study of Lung Cancer (IASLC) 2023 World Conference on Lung Cancer (Abstract PL03.13).
Background
Osimertinib—a potent third-generation epidermal growth factor receptor (EGFR) tyrosine kinase (TK) inhibitor with central nervous system activity—has recently garnered attention for its targeted inhibition of both sensitizing and resistance EGFR mutations.
Study Methods and Results
In the new FLAURA2 trial, researchers enrolled 557 patients and randomly assigned them 1:1 to receive either osimertinib plus chemotherapy—involving a regimen of 80 mg of osimertinib daily alongside pemetrexed and either cisplatin or carboplatin—or osimertinib monotherapy.
The new research builds on the favorable results observed in the phase III FLAURA trial, in which osimertinib displayed superiority over comparator EGFR TK inhibitors.
The researchers discovered that the patients who received the combination therapy experienced an 8.8-month enhancement in median progression-free survival (hazard ratio = 0.62, 95% confidence interval = 0.49–0.79, P < .0001) compared with the patients who received osimertinib monotherapy. Moreover, the objective response rate per investigator was notably higher in the combination therapy arm (83%) compared with the osimertinib monotherapy arm (76%).
Safety analyses indicated that the combination therapy was generally well-tolerated, with manageable adverse events.
Conclusions
“Results from the study demonstrated a remarkable improvement in progression-free survival with the osimertinib plus chemotherapy approach, showcasing a statistically significant reduction in disease progression risk compared [with] osimertinib monotherapy,” revealed lead study author Pasi A. Jänne, MD, PhD, Director of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute. “These findings mark a significant advancement in the management of advanced EGFR-mutated NSCLC. The FLAURA2 [trial] 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,” he concluded.
