AstraZeneca lung cancer drug meets survival endpoint in late-stage trial

March 9, 2023

AstraZeneca's EGFR inhibitor, Tagrisso, demonstrated strong overall survival benefit in a phase 3 trial for adjuvant treatment of patients with early-stage EGFR-mutated lung cancer, according to the drugmaker.

The randomized, placebo-controlled ADAURA trial enrolled 682 patients in early stages of epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) following tumor resection and in some cases adjuvant chemotherapy. According to AstraZeneca, positive high-level results from the ADAURA trial showed Tagrisso demonstrated a statistically significant and clinically meaningful improvement in overall survival, a key secondary endpoint, compared to placebo.

AstraZeneca says the new data confirms Tagrisso's potential to extend patients’ lives in early-stage disease. 

Tagrisso, which was given the green light by the FDA in 2017, is approved to treat early-stage lung cancer in more than 90 countries, including in the U.S., EU, China and Japan, and additional global regulatory reviews are ongoing. Tagrisso is also approved for the 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC and for the treatment of locally advanced or metastatic EGFR T790M mutation-positive NSCLC.

AstraZeneca has several ongoing trials focused on testing Tagrisso in earlier stages of lung cancer.