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
By Michael Dabaie
Puma Biotechnology Inc. said it presented interim results from its trial of neratinib in metastatic non-small cell lung cancer.
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.
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.
The company said eight patients experienced clinical benefit, which is confirmed complete response or partial response or stable disease for at least 16 weeks.
The median duration of response was 7.5 months and the median progression-free survival was 9.1 months.
Puma said enrollment in the second stage of this cohort continues.
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.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
January 29, 2021 08:35 ET (13:35 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
DJ Puma Biotechnology: Interim Results For Neratinib Show Clinical Benefit in 8 Patients
DJ彪馬生物技術公司：奈拉替尼的中期結果在8名患者中顯示臨牀益處
By Michael Dabaie
邁克爾·達拜(Michael Dabaie)著
Puma Biotechnology Inc. said it presented interim results from its trial of neratinib in metastatic non-small cell lung cancer.
彪馬生物技術公司(Puma Biotechnology Inc.)表示，該公司公佈了奈拉替尼治療轉移性非小細胞肺癌的中期試驗結果。
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.
彪馬説，這一結果是在帶有表皮生長因子外顯子18突變的轉移性非小細胞肺癌患者的隊列中得出的，這些患者之前曾接受過EGFR靶向酪氨酸激酶抑制劑的治療。
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.
試驗的中期療效結果顯示，在10名之前接受過EGFR酪氨酸激酶抑制劑治療的可評估患者中，有6名患者出現了部分反應，其中包括4名確認為部分反應的患者。
The company said eight patients experienced clinical benefit, which is confirmed complete response or partial response or stable disease for at least 16 weeks.
該公司表示，有8名患者體驗到了臨牀益處，即確認完全緩解或部分緩解或病情穩定至少16周。
The median duration of response was 7.5 months and the median progression-free survival was 9.1 months.
中位緩解期為7.5個月，中位無進展生存期為9.1個月。
Puma said enrollment in the second stage of this cohort continues.
彪馬説，這個隊列第二階段的招生工作仍在繼續。
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.
安全性簡介顯示，在試驗中接受奈拉替尼治療的11名患者中，沒有3級或更高級別腹瀉的報告。沒有患者需要維持劑量、減少劑量、住院或因腹瀉而永久停用奈拉替尼。
Write to Michael Dabaie at michael.dabaie@wsj.com
寫信給Michael Dabaie，電子郵件：michael.dabaie@wsj.com
(END) Dow Jones Newswires
(完)道瓊通訊社
January 29, 2021 08:35 ET (13:35 GMT)
2021年1月29日東部時間08：35(格林尼治標準時間13：35)
Copyright (c) 2021 Dow Jones & Company, Inc.
版權所有(C)2021年道瓊斯公司
譯文內容由第三人軟體翻譯。
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