UK-based pharmaceutical company AstraZeneca has reported that the FLAURA2 Phase III clinical trial of Tagrisso (osimertinib) combined with chemotherapy showed a consistent benefit in prespecified post-progression outcomes.
In the trial, Tagrisso was administered as an 80mg once-a-day oral tablet along with chemotherapy comprising pemetrexed and cisplatin or carboplatin every three weeks for four cycles, followed by maintenance with Tagrisso and pemetrexed.
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The randomised, multi-centre trial evaluated the combination therapy’s ability to treat locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC)
It involved 557 patients across more than 150 centres in more than 20 countries.
Progression-free survival (PFS) is the trial’s primary endpoint, while overall survival (OS) is its secondary endpoint.
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The trial is ongoing, but interim results have already shown a statistically significant improvement in PFS when chemotherapy is added to Tagrisso.
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By GlobalDataAt two years of follow-up, a favourable trend towards OS improvement with the combination regimen was reported.
The interim OS results, at 41% data maturity, reinforce this positive trend.
Safety analyses data showed that adverse events were most frequent and severe following the initial chemotherapy phase, but decreased during the maintenance period.
Tagrisso is an irreversible EGFR-tyrosine kinase inhibitor (TKI) that has been approved as a single agent in more than 100 countries, including the US, the European Union, China and Japan.
Last month, the US Food and Drug Administration granted approval for the use of Tagrisso plus chemotherapy following a priority review in this patient population.
AstraZeneca Oncology R&D executive vice-president Susan Galbraith said: “FLAURA2 reinforces Tagrisso as the backbone therapy in EGFRm non-small cell lung cancer either as monotherapy or in combination with chemotherapy, delivering the longest reported progression-free survival benefit in the 1st-line advanced setting.
“We’re excited to see a favourable trend toward overall survival and look forward to seeing this data mature over time.”
