AstraZeneca’s Tagrisso (osimertinib) combined with pemetrexed and platinum-based chemotherapy has shown improvement in overall survival (OS) for those with first-line locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).
According to the final analysis of the randomised Phase III trial, FLAURA2, it demonstrated a consistent survival benefit, echoing interim OS outcomes and building upon the earlier reported longest median progression-free survival (PFS) data for this setting.
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The combo showed OS improvements in the open-label, global, multi-centre trial when compared against Tagrisso as a single agent for this patient group.
Subjects in the trial received 80mg of Tagrisso daily in oral tablet form, combined with a chemotherapy regimen.
The chemotherapy included pemetrexed at a dosage of 500mg/m² and either cisplatin at 75mg/m² or carboplatin (AUC5) administered every three weeks for a total of four cycles.
After completing the cycles, the treatment continued with Tagrisso alongside maintenance doses of pemetrexed, also given every three weeks.
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By GlobalDataA total of 557 subjects were enrolled in the trial in more than 150 centres across over 20 nations, including in Asia, Europe, South America, and the US. PFS is the primary endpoint of the trial.
The combination therapy’s safety profile remained manageable, aligning with known profiles of the individual medicines.
According to the company, the trial recorded higher adverse event rates in the combination arm, attributed to expected chemotherapy-related effects. Discontinuation rates due to adverse events remained low.
These findings are set to be presented at an upcoming medical meeting and will be communicated to global regulatory bodies.
AstraZeneca oncology haematology R&D executive vice-president Susan Galbraith said: “These exciting overall survival results add to the extensive evidence supporting Tagrisso as the backbone therapy in EGFR-mutated lung cancer, demonstrating that Tagrisso plus chemotherapy can significantly extend survival in the first-line advanced setting, in addition to prior trials showing survival benefits as monotherapy in both early stage and advanced disease.”
More than 80 nations, including the European Union (EU), the US, Japan, and China, have currently approved Tagrisso + chemotherapy based on the FLAURA2 trial data.
In 2023, AstraZeneca reported positive outcomes from the ADAURA Phase III trial of Tagrisso in the adjuvant treatment of individuals with Stage IB, II, IIIA EGFRm NSCLC.
