AstraZeneca's Tagrisso Combined with Chemotherapy Receives FDA Approval for Significant CNS Progression Reduction in Advanced EGFRm NSCLC

Feb 19, 2024 07:31 CST Updated 07:31

AstraZeneca

Biopharmaceutical Manufacturer

▎WuXiEdited by Kant Content Team

AstraZeneca recently announced that the US FDA has approved a supplemental New Drug Application (sNDA) for its epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tagrisso (osimertinib) in combination with chemotherapy for the treatment of adult patients with locally advanced or metastatic EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC).

This FDA approval in the United States is primarily based on the results of the Phase 3 FLAURA2 clinical trial previously published in The New England Journal of Medicine.Compared with Tagrisso monotherapy (the global standard first-line treatment), the combination of Tagrisso and chemotherapy reduced the risk of disease progression or death by 38% (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, an improvement of 8.8 months over Tagrisso monotherapy (16.7 months).

The PFS results of the Blinded Independent Central Review (BICR) were consistent with the investigator's assessment, showingThe median PFS for patients receiving Tagrisso in combination with chemotherapy was 29.4 months, representing a 9.5-month improvement over Tagrisso monotherapy (19.9 months) (HR: 0.62; 95% CI: 0.48-0.80; p=0.0002).

▲Efficacy results of the FLAURA2 trial (Image source: Reference [2])

In the FLAURA2 trial, a pre-specified exploratory analysis conducted by BICR for patients with brain metastases at baseline showed,Compared with Tagrisso alone, the combination of Tagrisso and chemotherapy reduced the risk of central nervous system (CNS) disease progression or death by 42% (HR: 0.58; 95% CI: 0.33-1.01).After two years of follow-up observation, 74% of patients who received Tagrisso combined with chemotherapy did not experience CNS disease progression or death, compared to 54% of patients who received Tagrisso alone.

The safety of Tagrisso in combination with chemotherapy is generally manageable and consistent with the established characteristics of the different components in the combination therapy.

Tagrisso is a third-generation, irreversible EGFR-TKI., has been clinically proven to be effective for NSCLC. The approved indications for Tagrisso include the treatment of locally advanced or metastatic EGFRm NSCLC, first-line treatment for patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC, and adjuvant treatment for early-stage (IB, II, and IIIA) EGFRm NSCLC. In August 2023, Tagrisso in combination with chemotherapy was granted Breakthrough Therapy Designation by the U.S. FDA for the first-line treatment of adult patients with locally advanced or metastatic EGFRm NSCLC.

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References:

[1] Tagrisso with the addition of chemotherapy approved in the US for patients with EGFR-mutated advanced lung cancer. Retrieved February 16, 2024 from https://www.astrazeneca.com/media-centre/press-releases/2024/tagrisso-with-the-addition-of-chemotherapy-approved-in-the-us-for-patients-with-egfr-mutated-advanced-lung-cancer.html

[2] Tagrisso plus chemotherapy extended median progression-free survival by nearly 9 months in EGFR-mutated advanced lung cancer in FLAURA2 Phase III trial. Retrieved October 16, 2023 from https://www.astrazeneca.com/media-centre/press-releases/2023/tagrisso-plus-chemotherapy-extended-median-progression-free-survival-by-nearly-9-months-in-egfr-mutated-advanced-lung-cancer-in-flaura2-phase-iii-trial.html

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