KEY TAKEAWAYS
- The FLAURA2 phase III trial aimed to analyze CNS response and safety outcomes in a lung cancer trial comparing osimertinib with and without chemotherapy, focusing on blinded expert evaluation of brain tumors.
- The endpoints were CNS PFS, CNS response, and CNS DoR by CNS BICR.
- The result demonstrated that combining osimertinib with chemotherapy significantly improved brain tumor control in advanced lung cancer with manageable side effects.
The combination of osimertinib with platinum-pemetrexed (osi-CTx) significantly improved progression-free survival(PFS) compared to osimertinib monotherapy(osi-mono), demonstrating a manageable safety profile, with 40% of patients having baseline CNS metastases.
For a study, researchers aimed to analyze CNS response and safety outcomes in a lung cancer trial comparing osimertinib with and without chemotherapy, focusing on blinded expert evaluation of brain tumors.
Eligible patients (≥18 years [Japan: ≥20] with EGFRm advanced non-small cell lung cancer(NSCLC), no prior treatment for advanced NSCLC, asymptomatic CNS metastases stable >2 weeks after definitive treatment/steroids allowed) were randomized 1:1 to first-line osi-CTx or osi-mono until progression/discontinuation.
Brain imaging (MRI preferred) was conducted at baseline, progression, and scheduled assessments for patients with baseline CNS metastases. CNS endpoints (modified RECIST 1.1) included CNS PFS, CNS response, and CNS duration of response by CNS BICR. Safety was assessed by CTCAE v5.
Of 557 randomized patients, 118 in the osi-CTx group and 104 in the osi-mono group were included in the CNS BICR full analysis set (cFAS; pts with ≥1 measurable and/or non-measurable lesion), with 40 in osi-CTx and 38 in osi-mono included in the CNS evaluable for response set (cEFR; pts with ≥1 measurable lesion).
Demographics were balanced between treatment arms. CNS efficacy data are presented in the table. The safety profile was similar in the cFAS and overall population, with a detailed description of safety and tolerability throughout the treatment course to be provided.
The result demonstrated that combining osimertinib with chemotherapy significantly improved brain tumor control in advanced lung cancer with manageable side effects.
Source: https://cslide.ctimeetingtech.com/asia2023/attendee/confcal/show/session/45
Clinical Trial: https://clinicaltrials.gov/study/NCT04035486
Yu Y, Planchard D, Jänne PA, Cheng Y, Lee CK, Laktionov K, Yang TY, Kato T, Jiang L, Chewaskulyong B, Geater SL, Maurel JM, Rojas C, Havel L, Shepherd FA, Tanaka K, Ghiorghiu D, Monterroso EA, Huang X, Yang JCH. 512MO – FLAURA2: Safety and CNS outcomes of first-line (1L) osimertinib (osi) ± chemotherapy (CTx) in EGFRm advanced NSCLC. Presented at ESMO ASIA Congress 2023.(Session-512MO). Harbin, CN.
