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In an exploratory analysis of the overall trial population, Oghithini-assisted therapy reduced the risk of recurrence or death by 84% in patients who had previously received complementary chemotherapy (HR-0.16; 95% CI 0.10-0.26), reducing the risk of recurrence or death by 77% in patients who did not receive complementary chemotherapy (HR=0.23; 95% CI 0.13-0.40).
benefits of DFS in stages of each disease are similar.
In addition, a separate exploratory post-mortem analysis of outcomes reported by patients in ADAURA showed that patients treated with oxytinib maintained their quality of life, and that there was no clinical difference in physical or mental health indicators between the oghithini and placebo groups.
data, presented at this WCLC academic conference, highlight Oghidini's ability to penetrate the central nervous system (CNS) to transfer a patient's blood-brain barrier. Professor Wu Yilong, lead researcher of the
ADAURA trial, life-long director of Guangdong Provincial People's Hospital and honorary director of the Guangdong Lung Cancer Research Institute, said:
The overwhelming DFS benefits of patients in the ADAURA trial have supported the role of oxytinib as a pioneering therapy in EGFRm NSCLC-assisted therapy.
this latest analysis shows that the degree of benefit is consistent regardless of the stage of the disease, regardless of whether or not the assisted chemotherapy has been received in the past, reinforcing Oghidini's key role in this case.
, Executive Vice President, AstraZeneone Oncology, said: "These new data show that oxytinist provides "transformative" benefits independent of previous chemotherapy treatments to prevent lung cancer recurrence while maintaining a quality of life for patients.
we will continue to work urgently with regulators around the world to bring this new standard treatment to patients with early stage lung cancer, after Oghidini was recently approved for complementary treatment in the United States.
" ADAURA is a global, randomized, double-blind, placebo-controlled Phase 3 clinical trial that included 682 patients with IB, II, and IIIA stage EGFRm NSCLC who had previously undergone a complete excision and complementary chemotherapy.
trials, chemotherapy was balanced in both treatment groups, with 60 percent of the patients receiving complementary chemotherapy in the past.
consistent with previous studies and clinical practice, younger patients (70 years old) and those with more advanced diseases were more likely to have received complementary chemotherapy in the past.
the main results of ADAURA, published in the September 2020 issue of the New England Journal of Medicine, Oghithini-assisted therapy reduced the risk of recurrence or death by 83% in patients with phase II and IIIA EGFRm NSCLC (HR=0.17; 95% CI 0.12-0.23; p-lt;0.0001).
as the pre-defined exploratory analysis shows, Oghithini-assisted therapy led to clinically significant improvements in DFS in CNS patients compared to placebos.
resources: .1) Tagrisso extended disease-free survival regardless of prior adjuvant processy in early-stage EGFR-mutated lung cancer. Retrieved 2021-01-29, from