New data from the ADAURA phase 3 trial of osimertinib (Tagrisso; AstraZeneca) show a statistically significant and clinically meaningful improvement in overall survival (OS) in the adjuvant treatment of patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non–small cell lung cancer (NSCLC) after complete tumor resection with curative intent.
Earlier data showed a statistically significant and clinically meaningful improvement in disease-free survival (DFS) in this setting. In September 2022, updated results demonstrated a median DFS of nearly 5.5 years. The ADAURA trial protocols allowed patients on placebo who recurred with metastatic disease to receive open label osimertinib.
The new OS results in the early-stage resectable setting add to the large body of evidence for osimertinib in EGFRm NSCLC. The treatment now has shown a statistically significant and clinically meaningful OS benefit in both the early adjuvant and late-stage metastatic settings.
“These new survival data for osimertinib reinforce the unprecedented ADAURA disease-free survival results and confirm its potential to extend patients’ lives in early-stage disease,” said Roy S. Herbst, MD, PhD, principal investigator in the ADAURA phase 3 trial, in a press release. “The ADAURA results provide powerful evidence that osimertinib offers the best possible care for patients with early-stage EGFR-mutated non–small cell lung cancer who historically faced high rates of recurrence and previously had no targeted options after surgery.”
The safety and tolerability of osimertinib in the ADAURA trial were consistent with its established profile and no new safety concerns were reported. The data will be presented at an upcoming medical meeting.
Each year, there are an estimated 2.2 million individuals diagnosed with lung cancer globally, with 80% to 85% of patients diagnosed with NSCLC, the most common form of lung cancer. Between 25% and 30% of all patients with NSCLC are diagnosed early enough to have surgery with curative intent.
Additionally, 73% of patients with stage 1B and 56% to 65% of patients with stage 2 disease will survive for 5 years. This drops to 41% for patients with stage 3A and 24% for patients with stage 3B disease, highlighting the high unmet medical need.
Osimertinib is being investigated in several ongoing registrational trials in earlier stages of lung cancer, including in the neoadjuvant resectable setting in the NeoADAURA trial; in the stage 1A2-1A3 adjuvant resectable setting in the ADAURA2 trial; and in the stage 3 locally advanced unresectable setting in the LAURA trial.
It is approved to treat early-stage lung cancer in more than 90 countries, and other global regulatory reviews are ongoing. It is also approved for the first-line treatment of patients with locally advanced or metastatic EGFRm NSCLC and for locally advanced or metastatic EGFR T790M mutation-positive NSCLC.
“The ADAURA trial brought the first targeted medicine to patients with early-stage EGFR-mutated non–small cell lung cancer,” said Susan Galbraith, executive vice president of Oncology Research and Development at AstraZeneca, in the press release. “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.”
Tagrisso demonstrated strong overall survival benefit in the ADAURA phase III trial for adjuvant treatment of patients with early-stage EGFR-mutated lung cancer. News release. AstraZeneca; March 9, 2023. Accessed March 13, 2023. https://www.astrazeneca.com/media-centre/press-releases/2023/tagrisso-demonstrated-strong-overall-survival-benefit-in-the-adaura-phase-iii-trial.html