AstraZeneca Announces High-Level Positive Results from LAURA Phase III Trial of Tagrisso in Unresectable Stage III EGFR-Mutated NSCLC

China Finance and Economics News, February 23rd: The high-level positive results of the LAURA Phase III clinical study recently announced by AstraZeneca showed that in patients with Stage III unresectable epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC), progression-free survival (PFS) was statistically and clinically significantly improved in the group receiving Tagrisso (Osimertinib) after chemoradiotherapy compared to the group receiving placebo after chemoradiotherapy.

Although the overall survival (OS) data were not yet mature at the time of this analysis, the Tagrisso group showed a positive trend. This clinical study will continue to evaluate the secondary endpoint OS.

The total number of people diagnosed with lung cancer worldwide exceeds 2.4 million each year, of which 80%-85% are the most common non-small cell lung cancer (NSCLC). Approximately 10-15% of NSCLC patients in the United States and Europe have EGFR mutations (EGFRm), while the proportion is as high as 30-40% among Asian patients. More than one-sixth (15%) of NSCLC patients are diagnosed with Stage III unresectable lung cancer.

Suresh Ramalingam, MD, Executive Director of the Winship Cancer Institute at Emory University in Atlanta, USA, and the principal investigator of the LAURA study, stated that the findings represent a significant breakthrough for patients with EGFR-mutated Stage III lung cancer, particularly those at risk of early progression with brain metastases who currently have no targeted treatment options. "The LAURA study demonstrates that osimertinib provides clear clinical benefit and may become the first targeted therapy option for Stage III patients."

"Regarding early-stage lung cancer that may be curable, the results of the LAURA study have a profound impact. They not only further solidify osimertinib as a cornerstone in the treatment of EGFR-mutated lung cancer but, together with the findings from the ADAURA study, also underscore the critical importance of early diagnosis and early treatment for lung cancer patients," said Susan Galbraith, Executive Vice President of AstraZeneca and Head of Oncology R&D.

In the LAURA study, the safety and tolerability of osimertinib were consistent with the known safety profile, and no new safety issues were reported with osimertinib maintenance therapy after CRT.

These research data will be announced at the upcoming medical conference and shared with global health regulatory authorities. In addition, based on the FLAURA2 Phase III clinical trial, the indication for Tagrisso in combination with chemotherapy has recently been approved in the United States.

It is reported that the results of the NeoADAURA Phase III clinical trial, which evaluates the efficacy of osimertinib as a neoadjuvant therapy, are expected to be released later this year. The ADAURA2 Phase III clinical trial, assessing the efficacy of osimertinib as an adjuvant treatment in patients with early-stage resectable lung cancer, is also currently ongoing.