▎WuXiEdited by Kant Content Team

AstraZeneca today announced that in the FLAURA2 Phase III trial, its epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tagrisso (osimertinib) combined with chemotherapy as a first-line treatment provided clinically meaningful and consistent benefits for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease had progressed and whose tumors harbor epidermal growth factor receptor mutations (EGFRm).During the two-year follow-up, Tagrisso combined with chemotherapy also showed a favorable trend in improving overall survival (OS).The detailed results of the trial were published at the 2024 European Lung Cancer Conference (ELCC).

FLAURA2 is a randomized, open-label global Phase 3 trial that enrolled 557 patients with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFRm NSCLC to evaluate the efficacy and safety of Tagrisso oral tablets in combination with chemotherapy as a first-line treatment for this patient population. Enrolled patients received Tagrisso (once daily) in combination with chemotherapy (pemetrexed plus cisplatin or carboplatin, once every three weeks) for four cycles, followed by maintenance therapy with Tagrisso plus pemetrexed every three weeks. The primary endpoint of the trial was progression-free survival, with secondary endpoints including OS.

When data maturity reaches 41%,The interim OS results of the Tagrisso plus chemotherapy group showed a favorable trend (HR: 0.75; 95% CI: 0.57-0.97).Regardless of the patient's gender, race, EGFR mutation type, age at diagnosis, smoking history, performance status, and baseline central nervous system (CNS) metastasis status. The OS data are not statistically significant in this interim analysis and will continue to be evaluated as a key secondary endpoint in the final analysis.

Tagrisso combined with chemotherapy also demonstrated consistent benefits in the pre-specified endpoint of disease progression.Including time to first subsequent therapy or death (TFST; HR: 0.73; 95% CI: 0.56-0.94), progression-free survival after second-line treatment (PFS2; HR: 0.70; 95% CI: 0.52-0.93), and time to second subsequent therapy (TSST; HR: 0.69; 95% CI: 0.51-0.93).

▲Key in the FLAURA2 TrialEndpoint Results After Disease Progression (Image Source: Reference [1])

The primary results of the FLAURA2 Phase 3 clinical trial were previously published in The New England Journal of Medicine. Analysis shows,The trial met its primary endpoint, showing that the combination of Tagrisso and chemotherapy reduced the risk of disease progression or death by 38% compared to Tagrisso monotherapy (the global standard-of-care first-line treatment) (HR: 0.62; 95% CI: 0.49-0.79; p<0.0001).The investigator-assessed median progression-free survival (PFS) for patients receiving Tagrisso in combination with chemotherapy was 25.5 months, representing an improvement of 8.8 months over Tagrisso monotherapy (16.7 months).The U.S. FDA, based on these results, has already in February this yearApprovalTagrisso in combination with chemotherapy for the treatment of adult patients with locally advanced or metastatic EGFRm NSCLC.

Tagrisso is a third-generation, irreversible EGFR-TKI that has been clinically proven effective for NSCLC.Tagrisso is approved for the treatment of locally advanced or metastatic EGFRm NSCLC, first-line treatment of locally advanced or metastatic EGFR T790M mutation-positive NSCLC patients, and adjuvant treatment for early-stage (IB, II, and IIIA) EGFRm NSCLC.

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References:

[1] Tagrisso with the addition of chemotherapy showed favourable trend in overall survival in EGFR-mutated advanced lung cancer with further follow up in FLAURA2 Phase III trial. Retrieved March 21, 2024 from https://www.astrazeneca.com/media-centre/press-releases/2024/tagrisso-the-addition-chemotherapy-showed-favourable-trend-overall-survival-egfr-mutated-advanced-lung-cancer-further-follow-flaura2-phase-iii-trial.html

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