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Osimertinib: criteria for achievement based on evidence

来源         发布时间:2020-10-27
Osimertinib: criteria for achievement based on evidence
Lung cancer has become an incidence and mortality malignant tumor in China and even worldwide, and most patients have entered middle to late stage when diagnosed due to the non-specific symptoms.
Prior to the birth of osimertinib, the administration of first - and second-generation EGFR TKIs (gefitinib, erlotinib, afatinib, etc.) has prolonged the progression free survival (PFS) of EGFR sensitive mutation positive advanced non-small cell lung cancer (NSCLC) to more than 9 months, but EGFR-TKI resistance could not be avoided, Detected EGFR T790M resistance mutation in more than 60% of patients, for whom the third-generation EGFR TKIs became their new hope.
Osimertinib is a third-generation EGFR-TKI currently validated in phase III clinical studies worldwide
The third-generation EGFR-TKI osimertinib subverts the previous two generations' structure, redesigns the parent loop, and establishes irreversible binding, and preclinical studies confirmed that osimertinib is highly selective against both EGFR sensitive and EGFR T790M resistant mutations, while exhibiting great selectivity against the wild type with weak inhibition.
In two phase II clinical studies, aura ex and aura 2, patients with EGFR T790M resistance mutation were treated with osimertinib, and the objective response rate (ORR) reached 62% to 70% [1,2], also based on the results of these two studies, osimertinib was approved as a globally approved three generation EGFR-TKI through rapid approval by FDA in November 2015, And in 2016 was recommended by the national cancer comprehensive network (NCCN) guidelines for the treatment of NSCLC patients who had failed previous EGFR-TKI therapy and were positive for EGFR T790M resistance mutation.
In 2017, the results of the phase III aura 3 study of osimertinib were published, and in patients positive for the EGFR T790M resistance mutation, osimertinib achieved a median PFS of 10.1 months [3] and an orr of 71% [3], both significantly superior to conventional platinum containing doublet chemotherapy regimens. Based on the results of this phase III study, osimertinib received unconditional approval by the FDA, the aura 3 study changed clinical practice, and the 2017 NCCN guidelines also raised the grade of recommendation for osimertinib from 2a to a class 1 recommendation, which has been maintained to date.