(Lung Cancer) Is Tagrisso Effective?
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This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
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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