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A preset exploratory analysis of a Phase III ADAURA clinical study based on positive results showed that AstraZeneza's Terisa (chemical name: Ogini Osimertinib, trade name: Terisa Tagrisso) was in the early stages of undergoing a complete tumor excision (Complementary treatment in patients with non-small cell lung cancer (NSCLC) of EGFRm, a prefrontal growth factor change (EGFRm) in IB, II and IIIA periods, can lead to clinically significant improvements in the disease-free survival of the central nervous system (CNS) (DFS).
It is known that although nearly 30% of patients with non-small cell lung cancer can undergo treatment-related surgery due to early diagnosis, recurrence of the disease is still common in these early patients, where the recurrence of the central nervous system, that is, when the cancer spreads to the brain, is a common complication of EGFR mutation non-small cell lung cancer, and the recurrence of such patients usually has a very poor prognosis.
results were presented on September 19th at the Chair's Forum of the 2020 European Society of Oncology (ESMO) Online Annual Meeting (summary number: LBA1), and the main findings of the study were published simultaneously in the New England Journal of Medicine.
results suggest that fewer patients in the Oxitinib-assisted treatment group experienced recurrence or death (11% vs. 46%) than in the placebo group.
in patients who had already had a recurrence of the disease, 38 percent in the Oxitinib group had metastasis recurrence, up from 61 percent in the placebo group.
significantly reduced the risk of recurrence or death of the central nervous system by 82%.
two groups did not achieve a disease-free life of the central nervous system (CNS DFS).
post-mortem analysis suggested that in patients who had not previously experienced recurrence in other areas, patients treated with oxytinib had an estimated 1 percent lower risk of recurrence of brain disease at 18 months, compared with 9 percent in the placebo group.
study focused on disease-free survival in terminal-II and IIIA patients, Oghithini-assisted therapy reduced the risk of disease recurrence or death by 83%.
Masahiro Tsuboi, director of chest and oncology at the National Cancer Center Hospital in eastern Japan and lead researcher on ADAURA research, said: "It is time to change the notion that treatment for early EGFR mutant lung cancer is discontinued after surgery, because even after complementary chemotherapy, the recurrence rate remains high.
the latest data released this week show low recurrence rates - especially in the brain, and significant disease-free survival benefits - and show that oxytinists can prolong tumor-free survival in patients.
the lung cancer spreads to the brain, patients usually have a very poor prognosticity," said Jose Baselga, global executive vice president and head of oncology research and development at AstraZeneta.
we are now seeing that Oghidini has the ability to penetrate the blood-brain barrier, and the data further validate the effectiveness of Oghidini in the progress of brain transfer therapy.
excellent new data suggests that oxytinib can prevent brain metastasis in patients with early EGFR mutation lung cancer, and further demonstrates that oxytinib has made a truly revolutionary advance in the treatment of early EGFR mutation lung cancer.
, just as metastasis tumors are being treated globally, oghithini should also be the standard treatment for complementary treatments.
" Ocythinib's safety and tolerance in this study is consistent with previous studies of metastasis EGFR mutation non-small cell lung cancer.
the researchers assessed that the rate of adverse events greater than or equal to level 3 for any cause in the Oghitini group was 10 percent, compared with 3 percent in the placebo group.
has not yet been approved for complementary treatment in any country.
July 2020, Occidini was awarded a breakthrough therapy as an auxiliary treatment for patients with early EGFR mutation non-small cell lung cancer who had under been completely removed from the tumor for the purpose of healing.
Ocitini has been approved in the United States, Japan, China and the European Union for local late stage or metastasis EGFR mutation non-small cell lung cancer first-line treatment, as well as local late stage or metastasis EGFR T790M mutation non-small cell lung cancer treatment.
know a lot about lung cancer: lung cancer is the leading cause of cancer death in both men and women, accounting for about one-fifth of all cancer deaths.
, lung cancer is divided into non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), of which 80%-85% are non-small cell lung cancer.
most NSCLC patients are terminally ill at the time of diagnosis, of which only about 25-30% have access to surgery at the time of diagnosis.
most of the patients who had the opportunity to undergo surgery eventually relapsed despite complete tumor removal and complementary chemotherapy.
lung cancer is usually detected in imaging tests of other diseases before it is diagnosed, he said.
about 10-15% of non-small cell lung cancer patients in the United States and Europe have EGFR mutations (EGFRm), while the proportion in Asian patients is as high as 30-40%.
these patients are particularly sensitive to the treatment of the skin growth factor subject tyrosine kinase inhibitor (TKI), which blocks the signaling pathway that drives tumor cell growth.
ADAURA Clinical Study ADAURA is a randomized, double-blind, placebo-controlled Global Phase III clinical trial in which 682 patients with IB, II, IIIA EGFRm-positive non-small cell lung cancer received complementary treatment, and patients who had previously received complete tumor removal and complementary chemotherapy.
patients receive oral oxytinib once a day, or a placebo, for 3 years or until the disease returns.
the trial was conducted in more than 200 centers around the world, involving more than 20 countries including the United States, Europe, South America, Asia and the Middle East.
the main study endpoints are DFS for Phase II and IIIA patients, and the key secondary study endpoints are DFS for Phase II, Phase II and PHASE IIIA patients.
data release was originally expected in 2022.
will continue to evaluate total lifetime (OS) data.
Terisha Terisha (Osetini) is an irreversible third-representative skin growth factor subject tyrosine kinase inhibitor (EGFR-TKI) with clinical activity against CNS metastasis.
oral tablets of 40mg and 80mg daily have been approved in the United States, Japan, China, the European Union and many countries and regions of the world for first-line treatment of advanced NSCLC with EGFR mutation and treatment for patients with advanced NSCLC mutation of EGFRT790M mutation.
AstraZeneta's research in the field of lung cancer AstraZeneta has several drugs that have been approved or are in the late stages of clinical development and are suitable for lung cancer diseases with different histological parameters, different stages of treatment, and different mechanisms of action.
AstraZeneza aims to address the unsettly clinical needs of patients with EGFR mutation tumors through approved listings of Iresha (Giftonini) and Oghitini, as well as the ongoing Phase III LAURA study, the NeoADAURA study, and the FLAURA2 study.
AstraZeneca is committed to evaluating the treatment options of Savolitinib, a selective inhibitor of the c-MET subject tyrosine kinase, and other potential new drugs through the ongoing Phase II SAVANNAH study and ORCHARD study to find treatments that can effectively respond to tumor resistance mechanisms.
that the drug use in these studies has not yet been approved for use in China and That AstraZeneta does not recommend any unsanced drug use.
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