Puma Biotechnology: Interim Results For Neratinib Show Clinical Benefit in 8 Patients
Puma Biotechnology: Interim Results For Neratinib Show Clinical Benefit in 8 Patients
DJ Puma Biotechnology: Interim Results For Neratinib Show Clinical Benefit in 8 Patients
DJ彪马生物技术公司：奈拉替尼的中期结果在8名患者中显示临床益处
By Michael Dabaie
迈克尔·达拜(Michael Dabaie)著
Puma Biotechnology Inc. said it presented interim results from its trial of neratinib in metastatic non-small cell lung cancer.
彪马生物技术公司(Puma Biotechnology Inc.)表示，该公司公布了奈拉替尼治疗转移性非小细胞肺癌的中期试验结果。
Puma said the results were in the cohort of metastatic non-small cell lung cancer patients with epidermal growth factor exon 18 mutations who have been previously treated with an EGFR targeted tyrosine kinase inhibitor.
彪马说，这一结果是在带有表皮生长因子外显子18突变的转移性非小细胞肺癌患者的队列中得出的，这些患者之前曾接受过EGFR靶向酪氨酸激酶抑制剂的治疗。
The interim efficacy results from the trial showed that for the 10 evaluable patients who had previously been treated with an EGFR tyrosine kinase inhibitor, six experienced a partial response, which included four with a confirmed partial response.
试验的中期疗效结果显示，在10名之前接受过EGFR酪氨酸激酶抑制剂治疗的可评估患者中，有6名患者出现了部分反应，其中包括4名确认为部分反应的患者。
The company said eight patients experienced clinical benefit, which is confirmed complete response or partial response or stable disease for at least 16 weeks.
该公司表示，有8名患者体验到了临床益处，即确认完全缓解或部分缓解或病情稳定至少16周。
The median duration of response was 7.5 months and the median progression-free survival was 9.1 months.
中位缓解期为7.5个月，中位无进展生存期为9.1个月。
Puma said enrollment in the second stage of this cohort continues.
彪马说，这个队列第二阶段的招生工作仍在继续。
The safety profile showed that for the 11 patients who received neratinib in the trial, there were no reports of grade 3 or higher diarrhea. No patients required a dose hold, dose reduction, hospitalization or permanently discontinued neratinib due to diarrhea.
安全性简介显示，在试验中接受奈拉替尼治疗的11名患者中，没有3级或更高级别腹泻的报告。没有患者需要维持剂量、减少剂量、住院或因腹泻而永久停用奈拉替尼。
Write to Michael Dabaie at michael.dabaie@wsj.com
写信给Michael Dabaie，电子邮件：michael.dabaie@wsj.com
(END) Dow Jones Newswires
(完)道琼通讯社
January 29, 2021 08:35 ET (13:35 GMT)
2021年1月29日东部时间08：35(格林尼治标准时间13：35)
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