neue Studienergebnisse zur Therapie von Mesotheliomen, dem nicht-kleinzelligen Lungenkarzinom und dem … ADAURA (NCT02511106) is a Ph III, double-blind, randomized study assessing the efficacy and safety of osimertinib vs placebo (PBO) in pts with stage IB–IIIA EGFRm NSCLC after complete tumor resection and adjuvant chemotherapy, when indicated. This site is intended for healthcare professionals onlyASCO 2020 conference hub (lung and thoracic tumors) EClinical Systems for Clinical Trials ASCO 2020 news: Phase 3 ADAURA trial shows a significant DFS benefit with adjuvant osimertinib in patients with early-stage, EGFR-mutated NSCLC. In April, an Independent Data Monitoring Committee (IDMC) recommended the ADAURA trial to be unblinded two years early after the determination of overwhelming efficacy and the detailed results were presented at ASCO 2020 for the first time. Unsere Experten diskutierten die Highlights virtuell und hoben dabei u.a. Comparator Drugs and EU Open Market Solutions for Clinical Trials Wichtige Ergebnisse von u.a. NSCLC represents 85% of all lung cancer cases, with an estimated 30% of patients presenting with the resectable disease at diagnosis. The ADAURA trial was really one of the highest-profile presentations at ASCO 2020, as reflected by its status as one of the plenary abstracts. One of the first actionable biomarkers to be discovered in NSCLC was the molecular alteration of the EGFR gene, and EGFR inhibitors first entered clinical development in 1997. In April, an Independent Data Monitoring Committee (IDMC) recommended the ADAURA trial to be unblinded two years early after the determination of overwhelming efficacy and the detailed results were presented at ASCO 2020 for the first time. Adjuvant osimertinib demonstrated a statistically significant and clinically meaningful benefit for patients with stage IB, II, or IIIA EGFR-mutant non-small cell lung cancer (NSCLC) with complete tumor resection in the phase 3 ADAURA trial, presented at the Virtual ASCO Annual Meeting held 29-31 May 2020 [1]. This success has placed AstraZeneca’s Tagrisso as the standard of care in the first-line advanced EGFR mutated population and is the top-selling brand in a resurgent AZ oncology portfolio.For the first time, the ADAURA trial has demonstrated the overwhelming benefit of adding a targeted agent to the treatment paradigm for patients with EGFR mutated early-stage NSCLC. Surgery is the primary treatment for patients with early-stage NSCLC, while adjuvant cisplatin-based chemotherapy is recommended for patients with resected stage II-IIIA NSCLC. This latest approval will help Tagrisso inevitably achieve significantly higher annual sales in 2020. Physician Weekly interviewed the study’s principle investigator and presenter at ASCO… Please enable JavaScript on your browser, so that you can use all features of this website.The third-generation EGFR–tyrosine kinase inhibitor was associated with a significant 79% reduction in the risk for relapse or death relative to placebo in these patients, reported Roy Herbst, from the Yale School of Medicine in New Haven, Connecticut, USA, at the virtual 2020 ASCO Annual Meeting.Lecia Sequist explains why the ADAURA trial could be practice changing (5:17).“Therefore, adjuvant osimertinib provides a highly effective, practice changing treatment for patients with stage IB/II/IIIA The trial – which was unblinded early on the recommendation of the Independent Data Monitoring Committee – included 682 patients with either the The primary endpoint was DFS in patients with stage II and IIIA disease (69% in each group), and the risk for relapse or death was reduced by a significant 83% with osimertinib versus placebo, which Herbst said was “much better than expected.” The respective 2-year DFS rates were 90% and 44%.The decreased risk associated with osimertinib treatment remained significant when all study participants, including those with stage IB disease, were considered, with a risk reduction of 79% and 2-year DFS rates of 89% and 53% for the osimertinib and placebo groups, respectively.Herbst highlighted that the results were consistent across all subgroups, with patients deriving a DFS benefit from osimertinib treatment regardless of sex, age, race, disease stage, smoking status, Additionally, osimertinib was “very well tolerated,” said the presenter, with low rates of grade 3–4 adverse events, mainly diarrhea and stomatitis, each of which occurred in 2% of osimertinib-treated participants.He pointed out that prolonged QTc was observed in 7% of patients in the osimertinib group versus 1% of those in the placebo group, but Herbst pointed out that the adverse event was mostly low grade.

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