Tagrisso Extends NSCLC Success with Phase III Results

AstraZeneca has reported promising results from the Phase III LAURA trial, indicating that Tagrisso (osimertinib), as a maintenance therapy, significantly improves progression-free survival for patients with unresectable, stage III EGFR-mutated non-small cell lung cancer (NSCLC). Although specific data were not disclosed, the company highlighted that the improvement in progression-free survival was both statistically significant and clinically meaningful, particularly for those who had undergone chemoradiotherapy.

The drug also exhibited a favorable trend in overall survival, which is a key secondary outcome. However, the data for this metric were not fully mature at the time of the analysis, and the study will continue to collect data on overall survival. AstraZeneca plans to present the full results of the LAURA trial at a future medical conference.

Susan Galbraith, AstraZeneca's executive vice president for oncology R&D, emphasized the significance of the LAURA findings, stating that they reinforce Tagrisso's position as a foundational treatment for EGFR-mutated lung cancer. The LAURA trial was a rigorous, randomized, double-blinded, and placebo-controlled study that included 216 patients with unresectable stage III NSCLC with EGFR gene mutations. All participants had not experienced disease progression after receiving platinum-based chemoradiotherapy.

In terms of safety, the LAURA trial confirmed that the adverse events associated with Tagrisso were consistent with previous findings, with no new safety concerns documented. This announcement comes on the heels of Tagrisso's recent approval for use in combination with chemotherapy for the treatment of advanced EGFR-mutated NSCLC, broadening treatment options for patients, especially those with a poorer prognosis, including those with brain metastases.

Tagrisso is an EGFR tyrosine kinase inhibitor that targets specific mutated forms of EGFR, which are linked to cell growth and proliferation and are associated with a poor prognosis. It is designed to target sensitizing EGFR mutations and acquired resistance mutations. In addition to its recent approval, Tagrisso has three other indications for NSCLC: as a first-line treatment for metastatic disease, as adjuvant therapy post-resection, and as a treatment for metastatic disease that has progressed following prior EGFR-TKI therapy. For all these indications, Tagrisso's approval is specific to patients with certain EGFR mutations, as determined by an FDA-approved test.