Pharma Strategy Blog

Commentary on Pharma & Biotech Oncology / Hematology New Product Development

“At a time when cancer still kills one in four Americans, it is a job that requires as much hubris as heart. To chronicle the trial of the drug known as PLX4032 is to ride a roller coaster of breakthroughs and setbacks at what many oncologists see as a watershed moment in understanding the genetic changes that cause cancer.”

Source: The New York Times

The NY Times is running a three-part series on PLX4032, a B-Raf inhibitor being developed for the treatment of malignant melanoma by Plexxikon and Roche/Genentech.  Hat tip to my buddy Bill Scully of the HCA Group for sending the link.  Today, was the first installment in the series.  The article, although a little breathless and hypey for my taste, is well worth reading. 

A few years ago, I interviewed the physician, Dr Keith Flaherty involved in the trials at the American Society of Clinical Oncology (ASCO) meeting, after he presented the initial phase I results of the trial.  Most interviews usually take about 5-10 mins, because the researcher is busy and rushing between sessions.  Dr Flaherty stopped and chatted about the disease, treatments, the new data and it’s implications for 40 minutes.  His energy and enthusiasm for finding a better treatment for his patients was both palpable and admirable.  He reminded me vividly of Dr Brian Druker from OHSU, who I worked with at Novartis (a former employer and a client) on the drug Gleevec in CML.

The reality of phase I cancer trials is that many patients will sadly die and most drugs fail to offer any sign of efficacy or have toxic side effects that prevent pursuing further development.  I sincerely hope the Plexxikon/Roche agent actually amounts to something; the companies announced the commencement of phase III trials last month, which is a promising sign.

Every once in a while, something comes along where the science, biology and clinical development totally gel, offering new hope and promise for everyone involved from patients to physicians to Pharma company.  That’s what you all live for and work countless long hours to make happen. 

It’s the stuff dreams are made of.

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5 Responses to “Plexxikon and Roche's PLX4032 B-Raf inhibitor for melanoma”

  1. Erin Olsen

    Although the results so far are anecdotal, here’s hoping that PLX4032 is the real deal. A lot of companies are watching the story very closely- hoping it provides a demonstration project for how to rationally design a drug and companion diagnostic for a specific subset of cancer patients – should this be a success story, it will hopefully spur a lot more companies to head down this path.

  2. MaverickNY

    Hi Erin,
    Anecdotal? Actually the early results have been published in peer reviewed journals and also presented at major scientific meetings.
    Many oncologic agents in development or on the market already have a biomarker or diagnostic attached to them, so the concept isn’t new, but rather more companies are seeing the value in linking a test to screen for patients most likely to respond. For example, Herceptin and HER2, Gleevec and KIT in GIST, Tarceva and EGFR mutations in lung cancer and many others are in development.

  3. Srpemberton

    Maverick, what I would add to the above is that our diagnostic capabilities outweigh the available, effective drugs. You point out the major therapeutics above. The data for PLX4032 appears to be coalescing around a compelling story. Do you have any thoughts on the benefits of PLX4032 vs. GSK’s BRAF inhibitor; GSK2118436? Do you have any update posts to PLX that you can point me to?

    • maverickny

      Hi, if you use the Google Search box in the top right hand side of the blog you should be able to find all the posts on PLX4032 and GSK2118436 handily. We don’t have enough data on the GSK compound yet to make an informed comparison as it is further behind in development, but no doubt more data will emerge over the next few years. The likely next round of clinical trials will include BRAF combined with a MEK inhibitor and a BRAF plus ipilimumab. Those are the most obvious ones right now to overcome resistance and hopefully improve overall outcomes for patients.

      • Srpemberton

        Thank you for the assist. I love your blog for it’s valuable insights. Thank you for putting in the time to keep us informed and stimulate discussion.

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