AstraZeneca (AZ) has shared positive late-stage results demonstrating that Tagrisso (osimertinib) achieved a statistically significant improvement in progression-free survival for a subset of lung cancer patients.
The phase 3 LAURA trial randomised more than 200 patients with unresectable, stage 3 epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose disease had not progressed following definitive platinum-based chemotherapy (CRT).
Patients were treated with Tagrisso 80mg once-daily oral tablets until disease progression, unacceptable toxicity or other discontinuation criteria were met, or placebo after CRT.
Lung cancer is estimated to affect 2.4 million people globally every year, up to 85% of whom are diagnosed with NSCLC.
In the US and Europe, up to 15% of NSCLC patients have EGFR mutations, and one in six NSCLC patients are diagnosed with unresectable stage 3 disease.
Results from the study showed a favourable overall survival trend for Tagrisso, which the trial will continue to assess as a secondary endpoint.
In addition, the safety and tolerability of Tagrisso were consistent with the drug’s established profile, with no new safety concerns reported with Tagrisso maintenance treatment following CRT.
The ongoing LAURA trial will continue to assess Tagrisso in NSCLC patients and the data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.
Susan Galbraith, executive vice president, oncology research and development, AZ, said: “These highly impactful results for the LAURA trial in this potentially curative early lung cancer setting further entrench Tagrisso as the backbone therapy for EGFR-mutated lung cancer.
“This data, together with the ADAURA data, reinforces the imperative to diagnose and treat patients with lung cancer as early as possible.”
AZ’s NeoADAURA phase 3 trial is also investigating Tagrisso in the neoadjuvant setting, with results expected later this year, along with an early-stage adjuvant resectable setting in the ADAURA2 phase 3 trial.
Most recently, Tagrisso was granted approval by the US Food and Drug Administration to treat adult patients with locally advanced or metastatic EGFR-mutated NSCLC.