AstraZeneca notched another win with its tyrosine kinase inhibitor Tagrisso (osimertinib) in early-stage, non-small cell lung cancer. In the ADUARA trial, overall survival (OS) was doubled with Tagrisso compared to placebo. The trial comprised patients with epidermal growth factor receptor-mutated (EGFRm) positive tumors who were treated after surgery.
The final results of the trial were presented yesterday (abstract #LBA3) at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The New England Journal of Medicine. The trial’s primary data readout was originally anticipated in 2022, but data were reported early following preliminary positive disease-free survival (DFS) results.
“These highly anticipated overall survival results, with 88 per cent of patients alive at five years, are a momentous achievement in the treatment of early-stage EGFR-mutated lung cancer,” said Roy S. Herbst, MD, PhD, Deputy Director and Chief of Medical Oncology at Yale Cancer Center and Smilow Cancer Hospital, New Haven, and principal investigator in the trial.
He added that, “These data underscore that adjuvant treatment with osimertinib provides patients with the best chance of long-term survival.”
Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths. An estimated 2.2 million people are diagnosed with lung cancer around the world each year, 80-85% have NSCLC.
Tagrisso is already approved as monotherapy in more than 100 countries including the U.S., EU, China and Japan. It’s used as a first-line treatment of patients with locally advanced or metastatic EGFRm NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC, and adjuvant treatment of early-stage (IB, II and IIIA) EGFRm NSCLC. The drug is expected to reach $3 billion in peak annual sales.
In this trial, ADUARA, Tagrisso reduced the risk of death by 51% compared to placebo in both the primary analysis population (Stages II-IIIA) and in the overall trial population (Stages IB-IIIA).
In the primary analysis population, an estimated 85% of patients treated with the drug were alive at five years compared to 73% on placebo. In the overall trial population, an estimated 88% of patients treated with Tagrisso were alive at five years compared to 78% on placebo. Median OS was not yet reached in either population or treatment group.
“Tagrisso cut the risk of death by more than half in the adjuvant setting, further establishing this transformative medicine as the backbone treatment for EGFR-mutated lung cancer. These results emphasize the importance of diagnosing patients with lung cancer early, testing for EGFR mutations and treating all those with an EGFR mutation with Tagrisso,” said Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca.
The trial was enrolled in more than 200 centers across more than 20 countries, including the U.S., Europe, South America, Asia and the Middle East. The primary endpoint was DFS in Stage II and IIIA patients and key secondary endpoints included DFS in Stage IB, II and IIIA patients, and OS in both the primary and overall populations.