AstraZeneca's third-generation EGFR TKI, Tagrisso (osimertinib), has demonstrated advanced efficacy in treating stage-3 non-small cell lung cancer (NSCLC) in the chemoradiotherapy (CRT) setting. EGFR TKI refers to epidermal growth factor receptor tyrosine kinase inhibitor.

AstraZeneca said Monday, local time, that Tagrisso showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to placebo in patients with unresectable stage 3 EGFR-mutant NSCLC following CRT.

AstraZeneca compared Tagrisso to placebo in the double-blind, randomized, placebo-controlled phase 3 LAURA study in patients with unresectable stage 3 EGFR-mutant NSCLC whose disease has not progressed after platinum-based chemoradiotherapy.

The company recruited 216 patients from more than 145 medical institutions in 15 countries, including the United States, Europe, South America, and Asia. It subdivided participants into concurrent chemoradiotherapy (cCRT) vs. sequential chemoradiotherapy (sCRT) groups, stage 3A vs. stage 3B/3C groups, and Chinese vs. non-Chinese groups.

The primary endpoint was blinded independent central review committee (BICR)-assessed PFS according to RECIST v1.1 criteria; secondary endpoints were intracranial central nervous system progression-free survival (CNS PFS), overall survival (OS), PFS according to genetic mutation status, and safety (adverse events according to CTCAE v5 criteria).

AstraZeneca noted that OS data were not mature at the time of analysis but showed a trend in favor of the Tagrisso arm and plans to continue to evaluate OS. The company added that the safety and tolerability of Tagrisso in phase 3 were consistent with its established safety profile, and no new safety concerns were reported in Tagrisso maintenance treatment after CRT.

"Phase 3 data will be presented at upcoming congresses and shared with regulatory authorities worldwide," AstraZeneca said.

According to the company, about 2.4 million people worldwide are diagnosed with lung cancer each year, of which 80-85 percent are non-small cell lung cancer, the most common form of lung cancer. More than one in six patients with NSCLC is diagnosed with unresectable stage 3 disease.

"These results represent an important step forward for patients with stage 3 EGFR-mutant lung cancer, which has a high likelihood of early progression and metastasis to the brain and for which there are no targeted therapies," said Dr. Suresh Ramalingam, associate director of the Winship Cancer Institute at Emory University School of Medicine in Atlanta, Ga., LAURA's principal investigator.

The results of the LAURA study show that osimertinib can provide impactful clinical benefit and may be the first targeted treatment option for stage 3 patients, Ramalingam added.

"The LAURA results in patients with early, potentially curable lung cancer further solidify Tagrisso's position as a first-in-class treatment for EGFR-mutant lung cancer," said Susan Galbraith, senior vice president for Cancer R&D at AstraZeneca. "These data, along with the ADAURA data, reinforce the urgency to diagnose and treat lung cancer patients as early as possible."