(Lung Cancer) Is Tagrisso Effective?

On November 21, 2019, Suresh S. Ramalingam published in The New England Journal of Medicine the efficacy and safety results of the third-generation irreversible EGFR inhibitor Tagrisso (osimertinib) monotherapy in previously untreated, EGFR mutation-positive non-small cell lung cancer patients, from the FLAURA Phase III clinical trial.

The FLAURA Phase III trial randomized previously untreated, EGFR mutation-positive NSCLC patients (N=556) in a 1:1 ratio into the following two groups. The primary endpoint was progression-free survival (PFS) and the secondary endpoint was overall survival (OS).

• Tagrisso group: Tagrisso 80 mg once daily (N=279)
• Other EGFR TKI group: Gefitinib 250 mg once daily or erlotinib 150 mg once daily (N=277)

At the initial analysis, OS data were not yet mature and only the primary endpoint PFS was reported. Median PFS was: Tagrisso group 18.9 months vs. other EGFR TKI group 10.2 months — a significant 54% reduction in the risk of progression or death in the Tagrisso group (hazard ratio 0.46).

This publication also presents the results of the secondary endpoint overall survival:

Median OS was: Tagrisso group 38.6 months vs. other EGFR TKI group 31.8 months — a 20% reduction in the risk of death in the Tagrisso group (hazard ratio 0.80).

Overall survival rates at 12, 24, and 36 months were respectively: Tagrisso group 89%, 74%, 54% vs. other EGFR TKI group 83%, 59%, 44%.

In terms of safety, the rate of patients experiencing at least one adverse event was 98% in both groups. The rate of Grade 3 or higher adverse events was: Tagrisso group 42% vs. other EGFR TKI group 47%. The rate of serious adverse events was 27% in both groups.

Based on the FLAURA trial results, Suresh S. Ramalingam concluded: In previously untreated, EGFR mutation-positive NSCLC patients, Tagrisso monotherapy demonstrated improved overall survival compared with other EGFR tyrosine kinase inhibitors, with a comparable adverse event profile between the two groups regardless of treatment duration.

Source: Overall Survival with Osimertinib in Untreated, EGFR-Mutated Advanced NSCLC (N Engl J Med. 2019 Nov 21. doi: 10.1056/NEJMoa1913662.)

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Related Cancer Information

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