KEY TAKEAWAYS
- The Phase III FLAURA study aimed to gauge the effectiveness and safety of osimertinib combined with chemotherapy versus osimertinib alone in treating advanced NSCLC with EGFR mutations.
- The study’s primary endpoint was PFS, with secondary objectives like OS, ORR, and safety.
- The study demonstrated that combining osimertinib with chemotherapy improved PFS compared to osimertinib alone and had a manageable safety profile.
The Phase III FLAURA study included patients (pts) who were 18 years and older (20+ in Japan), with confirmed advanced/metastatic non-squamous non-small cell lung cancer (NSCLC), having specific mutations; WHO PS 0-1, without prior treatments for advanced NSCLC; those with stable brain metastases were included. They were divided equally between two treatments: osimertinib combined with chemotherapy or just osimertinib until disease progression. Stratifications included race, EGFR mutation testing method, and WHO PS. The primary goal was PFS, with secondary outcomes like OS, ORR, and safety.
In the study, 557 pts participated: 279 with the combined treatment and 278 with osimertinib alone. Basic attributes were comparable between the groups. The combination therapy showed a considerable improvement in PFS compared to just osimertinib. The median PFS increased by 8.8 months, with other assessments showing a 9.5-month increase. ORR was higher in the combination group at 83% versus 76%. Most pts finished the recommended platinum therapy cycles. OS data was not yet mature. Adverse events (AEs) were higher in the combination group, with 64% experiencing grade ≥3 AEs, primarily hematological.
Osimertinib with chemotherapy significantly enhanced PFS compared to osimertinib alone and had an acceptable safety profile. This combination is a promising first-line treatment for advanced NSCLC with EGFR mutations.
Source: https://cattendee.abstractsonline.com/meeting/10925/presentation/2752
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT04035486
Janne, P., Planchard, D., Cheng, Y., Yang, J.C-H., Yanagitani, N., Kim, S-W., Sugawara, S., Yu, Y., Fan, Y., Geater, S.L., Laktionov, K., Lee, C.K., Valdivieso, N., Ahmed, S., Maurel, J-M., Andrasina, I., Goldman, J., Ghiorghiu, D., Kulkarni, D., Huang, X., Kobayashi, K. Osimertinib With/Without Platinum-Based Chemotherapy as First-line Treatment in Patients with EGFRm Advanced NSCLC (FLAURA2)
