AstraZeneca (AZ) has shared positive overall survival (OS) results from a late-stage study of its epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tagrisso (osimertinib) in a subset of lung cancer patients.
The phase 3 FLAURA2 trial has been evaluating the drug in combination with pemetrexed and platinum-based chemotherapy in patients with first-line locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC).
Patients were treated with once-daily Tagrisso oral tablets alongside chemotherapy (pemetrexed plus cisplatin or carboplatin) every three weeks for four cycles, followed by Tagrisso with pemetrexed maintenance every three weeks.
According to high-level results announced by the company, the Tagrisso combination demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of OS compared to Tagrisso monotherapy, building on the previously presented primary endpoint data from the trial.
The safety profile of Tagrisso plus chemotherapy was also shown to be manageable and consistent with the established profiles of the individual medicines.
Susan Galbraith, executive vice president, oncology haematology research and development, AZ, said: “These exciting OS 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.”
An estimated 2.4 million people globally are diagnosed with lung cancer each year, with NSCLC accounting for up to 85% of all cases.
As many as 15% of NSCLC patients in the US and Europe have EGFR-mutated disease, a population that is particularly sensitive to treatment with an EGFR TKI that blocks the cell-signalling pathways that drive the growth of tumour cells.
Tagrisso, a third-generation irreversible EGFR TKI, plus chemotherapy is already approved in over 80 countries, including the US and Europe, based on results from FLAURA2.
Principal investigator for FLAURA2, Pasi Jänne, Dana-Farber Cancer Institute, said: “When treating lung cancer, the aim is to both prolong survival and improve the patient experience, especially in first-line where treatment duration can be long and many patients remain active.
“These positive results support [Tagrisso], either as monotherapy or in combination with chemotherapy, as standard of care for patients with first-line advanced EGFR-mutated lung cancer and reinforce the meaningful benefit of the combination in the current clinical setting.”