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)
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