AstraZeneta Tagrisso assists in the treatment of early EGFR mutation lung cancer: prolonging disease-free survival

AstraZeneca recently presented the results of an exploratory analysis of the treatment of lung cancer at the 21st World Lung Cancer Congress Chinese (WCLC) online conference 2020 hosted by the International Lung Cancer Research Association(WCLC).
data show that tagrisso-assisted therapy significantly prolongs disease-free survival (DFS) in patients with EGFRm non-small cell lung cancer (NSCLC), regardless of whether they have previously received complementary chemotherapy treatment or disease stage.
, Tagrisso achieved unprecedented DFS results in complementary treatments announced last year.
in this exploratory analysis of the entire trial population, Tagrisso-assisted therapy reduced the risk of recurrence or death by 84% in patients who had previously underwent complementary chemotherapy (HR-0.16, 95% CI:0.d) 10-0.26), reducing the risk of recurrence or death by 77% in patients who had not previously received complementary chemotherapy (HR=0.23; 95% CI: 0.13-0.40).
the benefits of DFS are similar at all stages of the disease.
in addition, a separate exploratory post-mortem analysis of the results reported by patients in the ADAURA study showed that patients treated with Tagrisso maintained their quality of life, and that there was no clinical difference in physical or mental health between the Tagrisso and placebo groups. Professor Wu Yilong, lead investigator of the
ADAURA Phase 3 trial and director of the Lung Cancer Research Institute of Guangdong Provincial People's Hospital, said: "In the ADAURA study, the huge disease-free survival benefits that patients have received have supported Tagrisso's role as a pioneering therapy for the complementary treatment of EGFR mutation non-small cell lung cancer.
this latest analysis shows that the benefits are consistent in size regardless of previous complementary chemotherapy, and that this reinforces Tagrisso's key role in this therapeutic environment, regardless of the stage of the disease.
Dave Fredrickson, executive vice president of AstraZeneta's oncology business unit, said: "These new data show that Tagrisso offers transformative benefits independent of previous chemotherapy treatments to prevent lung cancer recurrence while maintaining a quality of life for patients.
recent approval of Tagrisso for complementary treatment in the United States, we continue to work urgently with regulators around the world to provide this new standard of treatment for patients with early stage lung cancer.
"ADAURA is a randomized, double-blind, global, placebo-controlled Phase III study conducted in 682 early (IB/II/IIIA) EGFRm-NSCLC patients who have undergone complete tumor removal and optional standard postoperative assisted chemotherapy to assess the efficacy and safety of Tagrisso for complementary therapy.
study, patients in the experimental group received tagrisso 80mg of oral tablets once a day for three years or until the disease returned.
more than 200 clinical centers in more than 20 countries, including Europe, South America, Asia and the Middle East.
end point is disease-free survival (DFS) in patients with phase II/IIIA, and the key secondary endpoint is DFS in patients with phase II/II/IIIA.
the main findings of the study, published in the New England Journal of Medicine in September 2020, showed that (1) In patients with EGFRm NSCLC in Issue II and IIIA, tagrisso-assisted therapy reduced the risk of recurrence or death by 83% (HR=0.17; 95% CI: 0.12-0.23; p<0001).
(2) Tagrisso-assisted therapy reduced the risk of recurrence or death by 80% across the study group (IB/II/IIIA patients) (HR=0.20; 95% CI:0.15,0.27; p<0.0001).
as previously specified exploratory analysis shows, central nervous system (CNS) DFS has clinically significant improvements compared to placebos.
based on the unprecedented results of the ADAURA study, the FDA approved Tagrisso in December 2020 as an auxiliary (postoperative) therapy for the treatment of adult patients with early (IB/II/IIIA) EGFRm NSCLC who have under received a full tumor excision for therapeutic purposes.
Tagrisso is a third-generation irreversible skin growth factor subjectivity tyrosine kinase inhibitor (EGFR-TKI) that overcomes resistance to first- and second-generation EGFR-TKI in this class of drugs, including Roche/Astellatroca, Aslicon Eresha (Iressa), Grigg Ingehanlot Gilitini (afatinib, Afatinib).
Tagrisso inhibits EGFR-sensitive mutations and EGFR-T790M drug-resistant mutations, and has clinical activity against central nervous system metastasis.
To date, Tagrisso 40mg and 80mg daily oral tablets have been approved for first-line treatment of advanced EGFRm NSCLC in several countries (including the United States, Japan, China, and the European Union) and for second-line treatment of EGFR T790M mutation-positive late NSCLC patients in several countries.
addition, tagrisso has been approved in the United States and several other countries as an auxiliary (postoperative) therapy for the treatment of adult EGFRm NSCLC patients who have under received a full tumor excision for therapeutic purposes (IB/II/IIIA).
currently, AstraZene is developing Tagrisso for localized late-stage non-excisive disease (LAURA studies), combined chemotherapy to treat metastasis diseases (FLAURA2), and joint potential new drugs to address resistance to EGFR TKI (SAVANNAH, ORCHARD studies).
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