Rare Disease Report

Richard Bryce of Puma Biotechnology Talks Neratinib in Fibrolamellar

NOVEMBER 17, 2017
Richard Bryce, MBChB, MRCGP, MFPM
Richard Bryce, MBChB, MRCGP, MFPM, is the Senior Vice President of Clinical Research and Development for Puma Biotechnology.

At the Fibrolamellar Cancer Foundation (FCF) Summit, Rare Disease Report caught up with him to discuss his company’s interest in working with fibrolamellar cancer, and the challenges his group has faced in studying neratinib, an investigational compound frequently studied in breast cancer, in patients with the liver disease.

Bryce: So, we’ve had an interest – I, personally have had an interest – in fibrolamellar for some time. I’ve had some discussions with Dr (Ghassan) Abou-Alfa (Memorial Sloan Kettering Cancer Center), going back many years. As explained earlier this evening, we’ve got a trial running, a basket trial, which is looking at neratinib in tumors with HER2 mutations. The construct of the study lends itself to the sorts of niche indications the fibrolamellar represents; these small, rare tumors, ideally with a very specific biomarker or target to go after. It’s an area where we could very easily adapt an ongoing trial that we have to an orphan disease, such as fibrolamellar.

One of the biggest hurdles is really just getting the comfort level around neratinib around, or outside, the breast cancer community. Neratinib has been in development for breast cancer for a long time, so breast cancer physicians and breast cancer oncologists are pretty familiar with it, and accepting and understanding of the activity in breast cancer. Outside of breast cancer, it’s a relatively unknown quantity, and so that’s the biggest hurdle now. It’s translating that activity, which the breast cancer community has bought into for many, many years – not just with physicians, but also with nurses, caregivers, nurse navigators, and patients and advocacy groups – and translating that activity into other areas where there could be potential.


For more from the Fibrolamellar Cancer Foundation, visit the organization’s website: fibrofoundation.org.

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