Zenith thoughtsI’ve been curious about enzalutimide since Pfizer bought Medivation for $14 billion. My understanding is this is for 50% and Astella still holds 50%. For those that know please confirm or correct me on this.
So I’ve been trying to use this information to develop a timeline for the potential of the zen3694 trial.
So in very brief terms;
- Medivation started the phase lll trial called AFFIRM in Sept, 2009.
- The trial was stopped 2 years later in Nov 2011 by a DSMB recommendation because they found that enzalutimide extended the life expectancy of patients with mCRPC by 5 months.
- FDA approval was given 10 months later in August 2012.
- Pfizer buys Medivation in August 2016.
So zen3694 started dosing in June of 2016. The 3 x 3 trial will continue through 2017. Let us suppose there are extremely positive results and a good safety profile by the end of this year.
Since this is such a small trial I will assume they will have to move to large trials (please correct me if I am wrong) and these will take years to complete.
Lets guess that a large trial would take at least 2 years. That puts us out to the end of 2019 or early 2020. Then, if the FDA rushes things it puts us at the end of 2020 for approval and then probably months or a year to actually get to market.
I was hoping that a company like Pfizer would take note of the research. Perhaps with very strong results in the current trial they may begin to pay attention at some point in time.
One thing to note is that Pfizer did not buy Medivation until 4 years after FDA approval.
So I think we have a very long wait ahead of us.
Zenith has been silent. Is this good or bad. Perhaps early results are not positive...hence the silence. Or, as has been speculated on Agora, there may be a big deal in the works.
Anyway, I'm just thinking out loud. Anything can happen. Very high risk and potential high reward.
GLTA
Toinv - - - other Zenith background below.
Enzalutimide - Other Documents of Interest 2014 Research Article by the National Cancer Institute https://www.cancer.gov/types/prostate/research/enzalutamide-metastatic Article, Wed Dec 16th 2016 – PLATO Trial - Enzalutimide https://press.pfizer.com/press-release/pfizer-and-astellas-announce-top-line-results-phase-4-plato-trial-xtandi-enzalutamide-
“While the PLATO trial did not meet its primary endpoint
, it is critical that we continue to focus on addressing the unmet needs of men with metastatic CRPC, who have a poor prognosis despite treatment advances,” said Mohammad Hirmand, M.D., interim chief medical officer at Medivation, Inc., which is now part of Pfizer. “We will continue to analyze these data to better understand the results with the goal of further helping these patients.”
“XTANDI continues to remain an important treatment option for men with metastatic CRPC and their physicians. We are committed to continuing to explore the clinical potential of XTANDI across the disease continuum,” said Steven Benner, M.D., senior vice president, therapeutic area head for oncology development, Astellas.