Multinational phase 3 trial of first-line osimertinib with or without chemotherapy for EGFR-mutated advanced NSCLC

The multinational phase 3 FLAURA2 trial randomized patients who had not previously received treatment for EGFR-mutated (exon 19 deletion or L858R mutation) advanced non-small cell lung cancer 1:1 to osimertinib plus pemetrexed-platinum chemotherapy or osimertinib monotherapy. The primary end point was investigator-assessed progression-free survival. At 24 months, 57% of the patients in the combination group and 41% of the patients in the monotherapy group were progression-free (HR 0.62; p<0.001). Complete or partial response was seen in 83% of patients in the combination group and 76% of those in the monotherapy group, with median duration of response 24.0 months and 15.3 months, respectively. The safety profile of osimertinib plus chemotherapy was consisten with the known profiles of the individual agents. The authors conclude that among patients with EGFR-mutated advanced non-small cell lung cancer, addition of pemetrexed-platinum chemotherapy to first-line osimertinib resulted in significantly improved progression-free survival.