10P Safety and tolerability of first-line (1L) osimertinib (osi) ± platinum-pemetrexed in EGFRm advanced NSCLC: Data from FLAURA2

In FLAURA2 (NCT04035486) 1L osi with addition of platinum-pemetrexed chemotherapy (osi+CTx) showed significant PFS benefit vs osi alone (HR 0.62 95% CI 0.49, 0.79 p3 mos); ≥G3 AEs (64% overall for osi+CTx arm) reduced by approximately half from 49% (during 0–<3 mos) to 24% (during 3–‍<9 mos), and remained around this level for the rest of the tx period. The majority of ≥G3 AEs (osi+CTx arm) were haematological toxicities (neutropenia and anaemia), as expected from CTx-related AEs. AEs leading to osi discontinuation in the osi+CTx arm vs osi arm were 11% vs 6%; the most frequently reported events leading to discontinuation of osi in both arms were primarily those which mandated tx discontinuation by protocol, ILD (2% vs 2%) and pneumonitis (1% vs <1%). As expected, AE onset frequency and severity (osi+CTx arm) were highest during induction with clear reductions over time in the maintenance period. The addition of CTx had minimal impact on osi discontinuations. In FLAURA2, osi+CTx safety was consistent with the established profiles of osi and CTx, and manageable with standard medical practice.