Biotech Strategy Blog

Commentary on Science, Innovation & New Products with a focus on Oncology, Hematology & Cancer Immunotherapy

Posts tagged ‘APHINITY’

There’s nothing like a bit of controversy and heated debate at the annual meeting of the American Society of Clinical Oncology (ASCO) – every year seems to have something of note that generates intense debate and this June was no exception.

The main focus of this year’s intrigue was the APHINITY trial where pertuzumab (Perjeta) was added to the standard of care treatment – trastuzumab (Herceptin) plus chemotherapy for one year – in HER2+ adjuvant breast cancer.

The reality is that the findings from this trial are both subtle and nuanced so what did thought leaders really think about the data – what does the magnitude of the benefit mean and for whom should we be considering this approach for?

To find out, in the fourth post in our breast cancer series we interviewed some experts and curated sentiments around APHINITY to determine what the consensus was and where things are going next.

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If there’s one topic that has generated a LOT of questions from BSB readers this month it is Puma Biotech’s neratinib in adjuvant breast cancer.

The FDA briefing documents came out yesterday and that started another flurry of ‘what do you think of them?’ style questions so here goes.  I will say that while many are eulogizing ‘benign’ or ‘friendly’ on close reading and studying them, I’d say caveat emptor.

Things are not always what they seem.

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HI Koko Crater Flowers

Over the last week or so, we’ve received a lot of questions on the following topics relating to women’s cancers in breast and ovarian carcinomas:

  • APHINITY impact – pertuzumab and neratinib
  • PARPs in ovarian cancer – niraparib, rucaparib and olaparib
  • Seattle Genetics and Immunomedics

So this is probably a good time for a February BSB Reader Q&A post on the hot topics of the moment in cancer research.

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At the recent 2016 San Antonio Breast Cancer Symposium (SABCS16), Cascadian Therapeutics (NASDAQ: CASC) presented a poster (Abstract #P4–21–01) on:

“Efficacy Results of a Phase 1b Study of Tucatinib (ONT–380), an Oral HER2-Specific Inhibitor, in Combination With Capecitabine and Trastuzumab in HER2+ Metastatic Breast Cancer, Including Patients with Brain Metastases.”

Tucatinib is an oral tyrosine kinase inhibitor that is highly selective for HER2.

Cascadian’s tucatinib poster at #SABCS16

We’ve seen several new treatments approved for HER2 positive breast cancers in recent years including four targeted treatments: trastuzumab, pertuzumab, lapatinib and T-DM1.

Other companies such as Puma Biotech (NASDAQ: PBYI) also have oral TKIs in development. Puma’s drug, neratinib has, however been shown to have a high incidence of grade 3+ diarrhea, raising questions about its tolerance.

At SABCS16 (Abstract P02–11–03), the company presented the interim analysis of an open-label, multicenter phase 2 trial, which explored their compound:

“Incidence and severity of diarrhea with neratinib + intensive loperamide prophylaxis in patients (pts) with HER2+ early-stage breast cancer (EBC).”

There has been a lot of interest and controversy in this space, so it’s time to take a look at the latest events in HER2+ breast cancer and consider the ramifications since there are a number of new developments that are well worth following, including neratinib (Puma Biotech) and pertuzumab (Genentech).

This is our final expert interview from SABCS – if you missed it you can catch up with the rest of the conference coverage and thought leader sentiments here.

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