AstraZeneca (AZ) has shared positive results from a late-stage study evaluating Tagrisso (osimertinib) as an additional treatment for certain lung cancer patients.
The phase 3 ADAURA trial enrolled 682 patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) who had undergone surgery to remove their primary tumour.
Patients were treated with Tagrisso 80mg once-daily oral tablets or placebo for three years or until disease recurrence.
The results, which were presented at the American Society of Clinical Oncology annual meeting, showed that the drug reduced the risk of death by 51% compared to placebo in both the primary analysis population (patients with stages 2 to 3a EGFRm NSCLC) and in the overall trial population (stages 1b to 3a).
In the primary analysis population, an estimated 85% of Tagrisso-treated patients were alive at five years compared to 73% in the placebo cohort. In the overall trial population, around 88% of patients treated with Tagrisso were alive at five years compared to 78% on placebo.
Median overall survival was not yet reached in either population or treatment group, AZ said, adding that patients on placebo that recurred with metastatic disease were given the option to receive Tagrisso as a subsequent treatment.
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.
Approximately 25-30% of NSCLC patients present with resectable disease at diagnosis, but the majority of these patients eventually develop recurrence despite complete tumour resection and additional chemotherapy.
Susan Galbraith, executive vice president, oncology research and development, AZ, said: “Tagrisso cut the risk of death by more than half in the adjuvant setting, further establishing this transformative medicine as the backbone treatment for EGFR-mutated lung cancer.
“These results emphasise the importance of diagnosing patients with lung cancer early, testing for EGFR mutations and treating all those with an EGFR mutation with Tagrisso.”
Tagrisso already has regulatory approvals in more than 100 countries for certain patients with NSCLC who have a mutation of the EGFR gene.
AZ has also recently announced positive results from a phase 3 trial evaluating the drug in combination with chemotherapy in patients with locally advanced or metastatic EGFRm non-small cell lung cancer.
Πηγή: pmlive.com
