Tagrisso demonstrated an 82% reduction in the risk of central nervous system recurrence or death. The safety and tolerability of the product in the Phase III trial was consistent with previous trials in the metastatic EGFRm NSCLC setting.
AstraZeneca released new results from its ADAURA Phase III trial on Sept. 19, showing that its product Tagrisso (osimertinib) demonstrated clinically meaningful improvement in central nervous system disease-free survival (DFS) 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. The data was presented at the Presidential Symposium of the European Society for Medical Oncology Virtual Congress 2020, and primary results were published in The New England Journal of Medicine.
Overall, the analysis suggested that fewer patients treated with Tagrisso in the adjuvant setting had recurrence events or deaths, compared to the placebo. Among the subjects whose cancer returned, 38% of those who received Tagrisso had a metastatic recurrence, compared to 61% of patients who received a placebo.
Tagrisso demonstrated an 82% reduction in the risk of central nervous system recurrence or death. The safety and tolerability of the product in the Phase III trial was consistent with previous trials in the metastatic EGFRm NSCLC setting.
“It’s time to change the notion that treatment for early-stage EGFR-mutated lung cancer ends after surgery, since recurrence rates are still very high even after adjuvant chemotherapy,” said Masahiro Tsuboi, MD, Ph.D., director of the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East in Japan, and a principal investigator in the ADAURA Phase III trial. “These new data showing low rates of recurrence, particularly in the brain, combined with the remarkable disease-free survival benefit, clearly demonstrate that Tagrisso provides patients with more time living cancer-free.”
At the moment, Tagrisso is not approved in the adjuvant setting in any country. The product received Breakthrough Therapy Designation in July 2020 for the adjuvant treatment of patients with early-stage EGFRm NSCLC after complete tumor resection with curative intent.
“Once lung cancer has spread to the brain, outcomes are typically devastating for patients,” said José Baselga, Executive Vice President, Oncology R&D. “We are now seeing Tagrisso expanding on its proven efficacy in treating progression in the brain in the metastatic setting as a result of its ability to cross the blood-brain barrier. The striking new data show that Tagrisso prevents the development of brain metastases in patients with early disease and reinforce that this medicine is truly transformative for patients with EGFR-mutated lung cancer. Tagrisso should become the standard of care in the adjuvant setting, just as it is for patients with metastatic disease around the world.”
Tagrisso has been in the news as of late, with AstraZeneca reporting details from the Phase III ADAURA trial just this past May. In the study, the product demonstrated a statistically significant and clinically meaningful improvement in DFS in the adjuvant treatment of patients with early-stage epidermal growth factor receptor-mutated non-small cell lung cancer after complete tumor resection with curative intent.
At the two-year mark, 89% of patients who participated in the trial who were treated with Tagrisso remained alive and disease-free, compared to just 53% who received the placebo.
“These data are transformative for patients with early-stage EGFR-mutated non-small cell lung cancer who face high rates of recurrence even after successful surgery and subsequent treatment with adjuvant chemotherapy,” said Roy S. Herbst, MD, Ph.D., chief of Medical Oncology at Yale Cancer Center and Smilow Cancer Hospital, New Haven, CT and principal investigator in the Phase III ADAURA trial. “Tagrisso will provide a much-needed new treatment option that has the potential to change the practice of medicine and improve outcomes for patients in this setting.”
