AstraZeneca (AZ) has announced positive results from a phase 3 trial evaluating Tagrisso (osimertinib) in combination with chemotherapy in certain lung cancer patients.
The late-stage FLAURA2 trial enrolled 586 patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).
Patients were treated with Tagrisso 80mg once-daily oral tablets in combination with chemotherapy plus cisplatin or carboplatin every three weeks for four cycles, followed by Tagrisso with pemetrexed maintenance every three weeks.
The combination demonstrated strong improvements in progression-free survival compared to the drug alone.
Safety results were consistent with the established profiles of each medicine, AZ said, adding that the trial is ongoing and will continue to assess the secondary endpoint of overall survival.
An estimated 2.2 million people worldwide are diagnosed with lung cancer each year, with NSCLC accounting for up to 85% of all lung cancer cases.
The majority of all NSCLC patients are diagnosed with advanced disease, and up to 15% of NSCLC patients in the US and Europe have EGFRm NSCLC.
Susan Galbraith, executive vice president, oncology R&D, AZ, said: “These significant FLAURA2 results show Tagrisso has the potential to offer patients in the first-line setting a new treatment option that can extend the time they live without their disease progressing.
“This meaningfully builds on successive trials which have demonstrated improved clinical benefit with Tagrisso in patients with EGFR-mutated lung cancer.”
AZ recently announced positive results from a phase 3 trial evaluating Tagrisso as an additional treatment for patients with early-stage EGFRm NSCLC. The drug is also being investigated in unresectable NSCLC in a phase 3 trial, with results expected later this year.
The positive data from FLAURA-2 comes just over a month after AZ announced that its human monoclonal antibody, Imfinzi, had shown promising results when used before and after surgery in resectable early-stage NSCLC.
Interim results from the phase 3 AEGEAN study, which is assessing the PD-1/L1 inhibitor in combination with neoadjuvant chemotherapy before surgery and as a monotherapy after surgery, showed the regimen reduced the risk of disease recurrence, progression or death by 32%.
The combination also demonstrated a significant improvement in pathologic complete response, a dual primary endpoint, compared to chemotherapy alone, at a previously reported interim analysis.