19 February 2024
Tagrisso demonstrated overwhelming efficacy benefit for patients with unresectable, Stage III EGFR-mutated lung cancer in LAURA Phase III trial
First EGFR inhibitor and targeted treatment to demonstrate
progression-free survival benefit in Stage III setting
Positive high-level results from the LAURA Phase III trial showed AstraZeneca’s Tagrisso (osimertinib) demonstrated a statistically significant and highly clinically meaningful improvement in progression-free survival (PFS) for patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after chemoradiotherapy (CRT) compared to placebo after CRT.
Overall survival (OS) data showed a favourable trend for Tagrisso, although data were not mature at the time of this analysis. The trial will continue to assess OS as a secondary endpoint.
Each year an estimated 2.4 million people are diagnosed with lung cancer globally with 80-85% of patients diagnosed with NSCLC, the most common form of lung cancer.1-3 Approximately 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia, have EGFR mutations.4-7 More than one in six patients with NSCLC are diagnosed with unresectable Stage III disease (15%).8
Suresh Ramalingam, MD, Executive Director of Winship Cancer Institute of Emory University, Atlanta, US, and principal investigator in the trial, said: “These results represent a major advance for patients with Stage III EGFR-mutated lung cancer who have a high propensity for early progression and spread to the brain, and where no targeted therapy is available. LAURA shows osimertinib can provide impactful clinical benefit and could become the first targeted treatment option for patients with Stage III disease.”
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, 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. These data together with the ADAURA data, reinforce the imperative to diagnose and treat patients with lung cancer as early as possible.”
The safety and tolerability of Tagrisso in the LAURA trial was consistent with its established profile and no new safety concerns were reported with Tagrisso maintenance treatment following CRT.
The data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.
In addition, Tagrisso plus chemotherapy was recently approved in the US based on the FLAURA2 Phase III trial.
As part of AstraZeneca’s ongoing commitment to treating patients as early as possible in lung cancer, Tagrisso is also being investigated in the neoadjuvant setting in the NeoADAURA Phase III trial with results expected later this year, and in the early-stage adjuvant resectable setting in the ADAURA2 Phase III trial.