Cambridge, England – AstraZeneca on Monday released high-level results from the Phase III LAURA study, demonstrating clinical benefit for Tagrisso (osimertinib) as a maintenance treatment for patients with unresectable, stage III, EGFR-mutated non-small cell lung cancer.
The pharma did not reveal specific data in its announcement but said that Tagrisso led to a “statistically significant and highly clinically meaningful improvement” in progression-free survival (PFS) in the treatment setting when given to patients who had been treated with chemoradiotherapy.
Tagrisso also showed a “favorable trend” in terms of overall survival (OS), a key secondary outcome, though data for this endpoint were not yet mature at the time of the analysis. The study will continue to collect OS data. AstraZeneca will present LAURA data at an upcoming medical congress.
Susan Galbraith, executive vice president of oncology R&D at AstraZeneca, in a statement called LAURA’s findings “highly impactful” while noting that these results “further entrench Tagrisso as the backbone therapy for EGFR-mutated lung cancer.”
LAURA is a randomized, double-blinded and placebo-controlled trial that enrolled 216 patients with unresectable stage III NSCLC with mutations in the EGFR gene. All patients had not progressed after platinum-based chemoradiotherapy. Tagrisso was given at 80-mg, once-daily oral maintenance doses, while those in the placebo arm were allowed to take Tagrisso after their cancers had progressed.
In terms of Tagrisso’s safety profile in this earlier setting, LAURA found that adverse events were consistent with what had previously been established. The study documented no new safety concerns.
Monday’s readout follows Tagrisso’s recent approval for the treatment of advanced EGFR-mutated NSCLC in combination with chemotherapy, which further expands treatment options for NSCLC patients, especially those with a “poorer prognosis, including patients whose cancer has spread to the brain,” Dave Fredrickson, executive vice president of AstraZeneca’s oncology business unit, said in a statement.
Tagrisso is an EGFR tyrosine kinase inhibitor (TKI) that works by binding to specific mutated forms of EGFR, which would otherwise promote cell growth and proliferation, and which have been correlated with poor prognosis. According to its website, Tagrisso is designed to target sensitizing EGFR mutations, including exon 19 deletions and exon L858R mutations, as well as acquired resistance mutations.
Besides its most recent approval, Tagrisso has three other indications in NSCLC: as a first-line treatment option in patients with metastatic disease, as adjuvant therapy following resection and as treatment for metastatic disease that had progressed after prior EGFR-TKI therapy. In all three cases, Tagrisso is only approved for patients harboring specific EGFR mutations, as determined by an FDA-approved test.
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