▎WuXiEdited by Kant Content Team

AstraZeneca today announced that its epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tagrisso (osimertinib) in combination with pemetrexed and platinum-based chemotherapy has been approved in the European Union for the first-line treatment of adult patients with advanced epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose tumors have exon 19 deletions or exon 21 (L858R) mutations.

This EU approval is primarily based on the results of the FLAURA2 Phase 3 clinical trial previously published in The New England Journal of Medicine.Compared with Tagrisso monotherapy, 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, representing 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 receiving Tagrisso combined with chemotherapy did not experience CNS disease progression or death, compared to 54% of patients receiving 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 against NSCLC. The approved indications for Tagrisso include first-line treatment for locally advanced or metastatic EGFRm NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC; and adjuvant treatment for early-stage (IB, II, and IIIA) EGFRm NSCLC. In February 2024, Tagrisso in combination with chemotherapy receivedApproved by the U.S. FDA, as a first-line treatment for adult patients with locally advanced or metastatic EGFRm NSCLC.

References:

[1] Tagrisso with the addition of chemotherapy approved in the EU as new 1st-line treatment for patients with EGFR-mutated advanced lung cancer. Retrieved July 5, 2024 from https://www.astrazeneca.com/media-centre/press-releases/2024/tagrisso-with-the-addition-of-chemotherapy-approved-in-the-eu-as-new-1st-line-treatment-for-patients-with-egfr-mutated-advanced-lung-cancer.html

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