Photo: AstraZeneca sign outside the Swedish office/iStock, Wirestock
AstraZeneca on Monday announced high-level results from the Phase III LAURA trial, demonstrating the clinical benefit of Tagrisso (osimertinib) as maintenance therapy for patients with unresectable stage III EGFR-mutated non-small cell lung cancer.
Although the company did not provide specific data in its announcement, Tagrisso showed a “statistically significant and clinically significant improvement in progression-free survival (PFS) in the treatment setting when given to patients undergoing chemoradiotherapy.” “This has led to very meaningful improvements in terms of performance,” he said.
Tagrisso also showed a “favorable trend” in overall survival (OS), a key secondary outcome, although data for this endpoint were not yet mature at the time of analysis. The study continues to collect OS data. AstraZeneca plans to present her LAURA data at an upcoming medical conference.
Susan Galbraith, AstraZeneca’s executive vice president of oncology research and development, said in a statement that the LAURA study results are “highly impactful,” and that these results support “Tagrisso as a potential treatment for EGFR-mutated lung cancer. It will become even more established.”
LAURA is a randomized, double-blind, placebo-controlled trial that enrolled 216 patients with unresectable stage III NSCLC with mutations in the EGFR gene. All patients did not progress after platinum-based chemoradiotherapy. Tagrisso was administered at an oral maintenance dose of 80 mg once daily, but patients in the placebo group were allowed to take Tagrisso after their cancer had progressed.
Regarding the safety profile of Tagrisso in this initial setting, LAURA found that adverse events were consistent with those previously established. This study showed no new safety concerns.
Monday’s announcement follows Tagrisso’s recent approval for the treatment of advanced EGFR-mutated NSCLC in combination with chemotherapy, which allows patients with NSCLC, particularly those with “poor prognosis, including those whose cancer has spread to the brain” This will further expand treatment options for patients, said Dave Fredrickson. said in a statement, executive vice president of AstraZeneca’s oncology business.
Tagrisso is an EGFR tyrosine kinase inhibitor (TKI) that works by binding to specific mutant forms of EGFR. EGFR promotes cell growth and proliferation and is correlated with poor prognosis. According to Tagrisso’s website, Tagrisso is designed to target sensitizing EGFR mutations, such as exon 19 deletions and exon L858R mutations, as well as acquired resistance mutations.
In addition to the latest approval, Tagrisso has three other indications for NSCLC. as a first-line treatment option for patients with metastatic disease, as adjuvant therapy after resection, and as treatment for metastatic disease that has progressed after previous his EGFR-TKI therapy. In all three cases, Tagrisso is only approved for patients who have a specific EGFR mutation as determined by an FDA-approved test.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Contact him on LinkedIn or email tristan@tristanmanalac.com or tristan.manalac@biospace.com.
