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Putting patient welfare and quality survival at the fore. The FLAURA2 trial included pemetrexed with two platinum-based chemotherapy protocols – either cisplatin and carboplatin – allowing choice and flexibility in patient or treatment management.1-3
8.8 months longer vs 16.7 months TAGRISSO monotherapy
HR=0.62 (95% CI 0.49–0.79); P<0.0011
Primary endpoint
11.1 months longer vs 13.8 months TAGRISSO monotherapy
HR=0.47 (95% CI 0.33–0.66) P value not specified1
Pre-specified exploratory analysis
47.5 months in TAGRISSO with chemotherapy vs 37.6 months TAGRISSO monotherapy
HR (95% CI) 0.77 (0.61, 0.96); p=0.023
ARR 8% at 48 months, 57% data maturity
Secondary endpoint
In the first-line treatment of advanced EGFRm NSCLC, TAGRISSO with chemotherapy significantly increased median PFS by 8.8 months, compared to the TAGRISSO monotherapy arm.1
Patients in the combination arm had a median total exposure of 22.3 months for TAGRISSO, 2.8 months of platinum-based chemotherapy, and 8.3 months for pemetrexed.2–5
25.5 months mPFS in TAGRISSO with chemotherapy (95% CI 24.7, NC) vs. 16.7 months in TAGRISSO monotherapy (95% CI 14.1, 21.3)
HR=0.62 (95% CI: 0.49, 0.79); P<0.001. ARR 16% at 24 months
Overall data maturity: 51%
Adapted from Planchard D et al. N Engl J Med 2023.1
HR, hazard ratio; NC, not calculated; PFS, progression-free survival
29.4 months mPFS in TAGRISSO with chemotherapy (95% CI 25.1, NC) vs. 19.9 months in TAGRISSO monotherapy (95% CI 16.6, 25.3)
HR=0.62 (95% CI: 0.48, 0.80); P not specified, ARR 15% at 24 months (sensitivity analysis)
Adapted from Planchard D et al. N Engl J Med 2023.1
BICR, blinded independent central review; CI, confidence interval; HR, hazard ratio; NC, not calculated; PFS, progression-free survival
At 4 years, the longest median OS ever recorded in global phase III study, in first-line advanced EGFRm NSCLC, presented September 2025 at WCLC3
In the first-line treatment of advanced EGFRm NSCLC, TAGRISSO with chemotherapy significantly increased median OS by 9.9 months, compared to the TAGRISSO monotherapy arm.3
The data showed 47.5 months mOS in TAGRISSO + chemotherapy (95% CI 41.0, NC), vs 37.6 months mOS in TAGRISSO arm (95% CI 33.2, 43.2).
HR (95% CI) 0.77 (0.61, 0.96); p=0.02], ARR 8% at 48 months, 57% data maturity.
Overall survival is a key secondary endpoint of FLAURA2.
47.5 months mOS in TAGRISSO with chemotherapy (95% CI 41.0, NC) vs. 37.6 months in TAGRISSO monotherapy (95% CI 33.2, 43.2)
HR=0.77 (95% CI: 0.61, 0.96); P=0.02. ARR 8% at 48 months (sensitivity analysis)
Adapted from: Planchard D, Jänne PA, Kobayashi K, et al. First-line osimertinib + chemotherapy versus osimertinib monotherapy in EGFRm advanced NSCLC: FLAURA2 final overall survival [oral presentation]. Presented at: World Conference on Lung Cancer; September 6-9, 2025; Barcelona, Spain.3
ARR, absolute risk reduction; CI, confidence interval; HR, hazard ratio; NC, not calculated; mOS, median overall survival
Adapted from: Planchard D, Jänne PA, Kobayashi K, et al. First-line osimertinib + chemotherapy versus osimertinib monotherapy in EGFRm advanced NSCLC: FLAURA2 final overall survival [oral presentation]. Presented at: World Conference on Lung Cancer; September 6-9, 2025; Barcelona, Spain.3
Data cut-off: 12 June 2025.
*Two additional subgroups performed to fulfil regulatory requirements for diagnostics are not included: EGFR mutations by central cobas
® tissue test and EGFR mutations by central cobas® ctDNA test
†Race was reported by the patient.
‡For EGFR mutation type, patients with both Ex19del and L858R were included in the Ex19del group.
CI, confidence interval; CNS, central nervous system; ctDNA, circulating tumour DNA; CTx, chemotherapy; EGFR, epidermal growth factor receptor; Ex19del, Exon 19 deletion; HR, hazard ratio; mets, metastases; mono, monotherapy; OS, overall survival; osi, osimertinib; PH, proportional hazard; WHO PS, World Health Organization performance status.
Adapted from Planchard D, et al. 2025.
Data cut off 12 June 2025.
* Median (range) exposure in months of platinum chemotherapy is 2.8 (0.7 - 4.1); in cycles was 4 (1-6).
$ Median (range) exposure in months of pemetrexed is 8.3 (0.7 - 58.9); in cycles was 11 (1-67).
Median (range) exposure in months of osimertinib in combination arm is 30.5 (0.1 - 59.0).
Median (range) exposure in months of osimertinib in monotherapy arm is 21.2 (0.1 - 59.2).
Subsequent treatment was per investigator choice.
Adapted from Planchard D, et al. 2025.
Data cut off 12 June 2025.
*Denominator (127 for osi + CTx and 185 for osi mono) is the number of patients who discontinued osimertinib due to progression.
†Other included ADCs, immunotherapies [PD-(L)1 inhibitors], other investigational anticancer therapies, antiangiogenic therapies [VEGF(R) inhibitors], catequentinib hydrochloride, savolitinib, and unspecified herbal and traditional anticancer medicines.
ADCs, antibody-drug conjugates; CTx, chemotherapy; combo, combination; EGFR, epidermal growth factor receptor; FST, first subsequent treatment; mono, monotherapy; OS, overall survival; PD-(L)1, programmed cell death (ligand)-1; VEGF(R), vascular endothelial growth factor (receptor)
In a prespecified exploratory analysis of patients with CNS metastases at baseline, TAGRISSO with chemotherapy increased median PFS by 11 months despite pre-existing CNS metastases, compared to the TAGRISSO monotherapy arm.1
Over 2 years median PFS in patients with historically poor prognoses, receiving TAGRISSO with chemotherapy.1
24.9 months mPFS in TAGRISSO with chemotherapy (95% CI 22.0, NC) vs. 13.8 months in TAGRISSO monotherapy (95% CI 11.0, 16.7)
HR=0.47 (95% CI: 0.33, 0.66); P not specified. ARR 27% at 24 months (sensitivity analysis)
Adapted from Planchard D et al. N Engl J Med 2023.1
CI, confidence interval; CNS, central nervous system; HR, hazard ratio; PFS, progression-free survival
In a prespecified exploratory analysis of patients with brain metastases at baseline, TAGRISSO with chemotherapy demonstrated higher CNS responses compared to the TAGRISSO monotherapy arm, in the majority of patients, in the CNS full analysis set OR=1.19 (95% CI: 0.67–2.14); P=0.549.6 Improved CNS response rates were observed in patients who had brain metastases at baseline, a high-risk population.6
Adapted from Janne PA et al. J Clin Oncol 2023.6
*Target lesion definition from protocol: at least 1 lesion, not previously irradiated that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have a short axis of ≥15 mm) with CT or MRI, and that is suitable for accurate repeated measurements.7
†The median best percentage change from baseline in CNS target lesion size was –94% (range, –100% to +7%) with osimertinib plus platinum-pemetrexed and –61% (range, –100% to +68%).6
CNS, central nervous system
Adapted from Planchard D et al. N Engl J Med 2023.1
*6 patients who were randomised did not receive treatment.1
AUC, area under the curve; CNS, central nervous system; ECOG, Eastern Cooperative Oncology Group; EGFRm, epidermal growth factor receptor mutant; mNSCLC, metastatic non-small cell lung cancer; po, by mouth; qd, every day; TKI, tyrosine kinase inhibitor
Navigate the safety profile: FLAURA2 trial
Take a closer look at how TAGRISSO is administered: FLAURA2 trial
Learn more about how TAGRISSO works
AUC, area under the curve; BICR, blinded independent central review; CI, confidence interval; CNS, central nervous system; ECOG, Eastern Cooperative Oncology Group; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutant; HR, hazard ratio; mNSCLC, metastatic non-small cell lung cancer; MOA, mode of action; mPFS, median progression-free survival; NC, not calculated; NSCLC, non-small cell lung cancer; PFS, progression-free survival; PFS2, secondary progression-free survival; po, by mouth; PS, performance status; qd, every day; TKI, tyrosine kinase inhibitor
GB-69303 | DOP: October 2025
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