AstraZeneca Announces Tagrisso Reduced Risk of Recurrence or Death by 83% in Phase III ADAURA Trial for Early-Stage EGFR-Mutated NSCLC

Source: Jike Pharma News

Today, AstraZeneca announced detailed results from the Phase 3 ADAURA clinical trial of Tagrisso (osimertinib), its third-generation EGFR inhibitor. The trial evaluated the efficacy of Tagrisso as adjuvant therapy in patients with early-stage (Stage IB, II, and IIIA) non-small cell lung cancer (NSCLC) harboring EGFR mutations who had undergone curative tumor resection. The results demonstrated that Tagrisso provided a statistically significant and clinically meaningful improvement in disease-free survival (DFS). The press release highlighted that these findings have the potential to change the treatment paradigm for patients with early-stage NSCLC.

Lung cancer is the leading cause of cancer-related deaths in both men and women, accounting for approximately one-fifth of all cancer deaths. Lung cancer is broadly classified into non-small cell lung cancer (NSCLC) and small cell lung cancer, with 80–85% of cases categorized as NSCLC. Approximately 25–30% of NSCLC patients present with resectable disease at diagnosis. Despite undergoing surgical treatment with complete resection, a substantial proportion of NSCLC patients eventually experience recurrence. Approximately 10–15% of NSCLC patients in the United States and Europe, and 30–40% of patients in Asia, harbor EGFR gene mutations. These patients are particularly sensitive to treatment with EGFR tyrosine kinase inhibitors (TKIs).

Tagrisso is approved for first-line treatment of patients with locally advanced or metastatic EGFR-mutated NSCLC in the United States, Japan, China, the European Union, and many other countries worldwide.

In patients with stage II and IIIA disease, adjuvant Tagrisso reduced the risk of disease recurrence or death by 83% (HR=0.17; 95% CI: 0.12, 0.23; p<0.0001), meeting the primary endpoint of the trial. In the overall patient population, including stages IB to IIIA (key secondary endpoint), Tagrisso reduced the risk of disease recurrence or death by 79% (HR=0.21; 95% CI: 0.16, 0.28; p<0.0001).

▲ Primary Efficacy Results of the ADAURA Clinical Trial (Image Source: Reference [1])

At 2 years of treatment, 89% of patients in the Tagrisso-treated experimental group remained alive and disease-free, compared to 53% in the placebo group. Consistent DFS outcomes were observed across all subgroups, including patients who received chemotherapy after surgical resection and those who underwent surgery alone, as well as among Asian and non-Asian patients.

Dr. Roy S. Herbst, principal investigator of the ADAURA trial and from the Yale Cancer Center, stated, “These data are transformative for patients with early-stage EGFR-mutated non-small cell lung cancer (NSCLC), who face a high risk of recurrence even after successful surgery and subsequent adjuvant chemotherapy. Tagrisso will provide a much-needed new treatment option, with the potential to change medical practice and improve patient outcomes in this setting.”

Dr. José Baselga, Executive Vice President of Oncology R&D, said, “The significant results from the Phase III ADAURA trial of Tagrisso demonstrate for the first time in a global study that an EGFR inhibitor can alter the disease course of early-stage EGFR-mutated lung cancer and offer hope for cure. We are discussing these data with regulatory authorities and look forward to bringing the benefits of Tagrisso to patients with early-stage disease.”

The full results of this trial will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting on May 31 (Abstract #LBA5).

References:

[1] Tagrisso demonstrated unprecedented disease-free survival in the adjuvant treatment of Stage IB-IIIA patients with EGFR-mutated lung cancer. Retrieved 2020-05-28, from https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/tagrisso-demonstrated-unprecedented-disease-free-survival-in-the-adjuvant-treatment-of-stage-ib-iiia-patients-with-egfr-mutated-lung-cancer.html

83% Reduction in Risk of Recurrence/Death: AstraZeneca’s Tagrisso Shows Stunning Phase 3 Results in Early-Stage Lung Cancer

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