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Puma Bio's actions in mid-stage neratinib study point to continued problems with diarrhea side effect; shares slump 23%

Published 11/14/2016, 11:33 AM
Puma Bio's actions in mid-stage neratinib study point to continued problems with diarrhea side effect; shares slump 23%
PBYI
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  • Puma Biotechnology (PBYI -23.2%) heads south on increased volume in apparent response to the release of an abstract from an open-label Phase 2 clinical trial, CONTROL, assessing the ability of loperamide (L) to control the incidence and severity of diarrhea in HER2-positive early-stage breast cancer patients treated with neratinib. The data will be presented on December 8 at the San Antonio Breast Cancer Symposium.
  • Severe diarrhea (grade 3) is the major unwanted side effect of the pan-HER inhibitor. In clinical studies, the incidence rate has been as high as 40%.
  • The study is investigating the efficacy of loperamide prophylaxis in preventing neratinib-associated diarrhea. The red flag is the recent addition of budesonide (B), a steroid used to treat inflammation, to the study implying that loperamide alone has been unable to adequately prevent/control treatment-related diarrhea.
  • An interim analysis of 133 patients treated with L + B before neratinib showed an incidence rate of grade 3 or higher diarrhea of 12.5%, much lower than 27.1% for loperamide alone. Grade 2 diarrhea also decreased with the addition of budesonide, but not as much (18.8% versus 20.3%). The incidence rates in patients given no pretreatment were 39.9% and 32.5%, respectively.
  • The study is ongoing.

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