Tagrisso (osimertinib) is the first EGFR inhibitor and targeted treatment to demonstrate progression-free survival benefit in Stage III setting of non-small cell lung cancer – AstraZeneca

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. Approximately 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia, have EGFR mutations. More than one in six patients with NSCLC are diagnosed with unresectable Stage III disease (15%).

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.”

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.