AstraZeneca Tagrisso improves overall survival in lung cancer patients in phase 3 trial
Leon Neal

AstraZeneca (NASDAQ:AZN) said Tagrisso showed survival benefit in patients with a type of lung cancer who had undergone surgery, in a phase 3 trial.
The British pharma giant noted that in the late-stage study, dubbed ADAURA, Tagrisso (osimertinib) showed a statistically significant and clinically meaningful improvement in overall survival (OS) â which was a key secondary goal of the trial â compared to placebo in the adjuvant treatment of patients with early-stage (1B, 2, 3A) with epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) following complete tumor resection.
The study included 682 patients with early-stage EGFRm NSCLC following complete tumor removal and adjuvant chemotherapy. Patients were treated once-daily with the oral drug Tagrisso or placebo, for three years or until disease recurrence.
Adjuvant therapy is the additional cancer therapy given after the primary treatment, such as surgery for tumor removal. Adjuvant treatment may include chemotherapy and radiation therapy, among other things.
AstraZeneca had already reported the main goal from the study, which was disease-free survival (DFS) in May 2020.
The company noted Tagrisso showed a statistically significant and clinically meaningful improvement in DFS. Updated results in September 2022, showed a median DFS of nearly five and a half years.
The company said the data adds to the proof of Tagrisso in EGFRm NSCLC which has now shown a statistically significant and clinically meaningful OS benefit in both, early adjuvant and late-stage metastatic settings.
"Today, these exciting overall survival results validate adjuvant Tagrisso as the standard of care in this setting and reinforce the importance of early diagnosis and testing for EGFR mutation in lung cancer," said Susan Galbraith, executive vice president, Oncology R&D, AstraZeneca.
The company noted that the safety and tolerability of Tagrisso in the study were consistent with the drug's profile and no new safety concerns were seen.
AstraZeneca plans to present the data at an upcoming medical meeting.
Tagrisso is approved to treat early-stage lung cancer in more than 90 countries, including in the U.S, EU, China and Japan, according to the company.
In a separate release, AstraZeneca reported results from a phase 3 trial showing that Imfinzi-based therapy before and after surgery significantly increased the time patients with lung cancer lived without the disease recurring or progressing.
AZN +0.69% to $64.56 premarket March 9