Pfizer Dacomitinib gains significant survival benefit over gefitinib
June 06, 2018 Source: Sina Pharmaceutical
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];On June 4, Pfizer announced the overall survival data of dacomitinib as a first-line therapy for EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) patients in the ARCHER 1050 trial. The results showed that the overall survival of patients receiving dacomitinib was 34.1 months (95% CI: 29.5, 37.7) compared with the 26.8 months survival data of the gefitinib control group (95% CI: 23.7, 32.1). Shows improvements over 7 months. Survival data for the ARCHER 1050 study will be published as an oral report at this year's US ASCO meeting, and the Journal of Clinical Oncology will be published simultaneously.
Tony Mok, head of the Department of Clinical Oncology at the Chinese University of Hong Kong, said: "Overall survival is an important indicator for evaluating the effectiveness of a study compound. The data provided today is particularly important because dacomitinib is the first to compare in a clinical 3-stage head-to-head study. It also shows an overall survival-improving EGFR tyrosine kinase inhibitor. Dacomitinib is expected to be the first-line treatment for patients with EGFR-activated mutant non-small cell lung cancer."
Overall survival was the secondary endpoint of the ARCHER 1050 study, a randomized, open-label, phase 3 study comparing the efficacy and safety of dacomitinib with gefitinib in the first-line treatment of locally active or metastatic NSCLC with EGFR activating mutations. . The 30-month survival rate was 56.2% in patients receiving dacomitinib and 46.3% in patients receiving gefitinib. Among most baseline characteristics, subgroup analyses (including patients with common exon 19 and 21 mutations) were consistent with primary OS analysis.
The adverse events (AES) observed in this study were consistent with those of the previous dacomitinib trial. The most common AEs were diarrhea (87%), nail changes (62%), rash/dermatitis (49%), and oral ulcers (44%). The most common grade 3 adverse reactions in the dacomitinib group were rash (14%) and diarrhea (8%), and the incidence of grade 4 AEs was 2%. There were 1 case of grade 5 diarrhea and 1 case of grade 5 liver disease. The termination rate of treatment-related AEs was 10% for dacomitinib and 7% for gefitinib.
Dr. Mace Rothenberg, PhD in the development of Pfizer Oncology, said: "The most encouraging result of these results is that the median survival of patients with non-small cell lung cancer treated with dacomitinib is close to 3 years, with a significant improvement in survival compared to the control group. With today's report at the ASCO Annual Meeting and the priority review granted by the US FDA earlier this year, we are committed to providing this promising research drug to patients as soon as possible."
In April 2018, the US FDA granted the priority review of dacomitinib for the first-line treatment of EGFR-mutant NSCLC. The target review date for the FDA Prescription Drug Users Fee Act (PDUFA) is September 2018. The European Medicines Regulatory Agency has also accepted marketing authorization applications for dacomitinib and indication treatment. (Sina Pharmaceutical Compilation / David)
Article reference source: DACOMITINIB SHOWS MORE THAN SEVEN-MONTH IMPROVEMENT IN OVERALL SURVIVAL COMPARED TO AN ESTABLISHED THERAPY IN ADVANCED NSCLC WITH EGFR-ACTIVATING MUTATIONS
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