Genvec's TNFerade fails in phase III trials for pancreatic cancer
It's been a busy week on the road here at Icarus and today and tomorrow are no exception, so finding time to blog is a little more challenging.
Yesterday, I got back from a biomarker symposium in Princeton to find that my Twitter and almost everything else Pharma related were full of Genvec's announcement that their phase III trial for TNFerade was being discontinued in pancreatic cancer.
It's not really a drug, more an experimental gene therapy, that according to Genvec:
"Acts as an adenovector, or DNA carrier, which contains the gene for tumour necrosis factor-alpha (TNFα), an immune system protein. It is directly injected into the tumour. After administration, TNFerade stimulates the production of TNFα in the tumour."
The abandonment of the trial isn't really big news though, as the drug previously failed in melanoma and other cancers, despite the magic words, "promising phase II data." Let's face it, pancreatic cancer is also probably one of the toughest nuts to crack out there in the oncology world. Sadly, it was doomed to failure from the beginning; I would have been more surprised had it actually worked.
Genvec have a raft of other trials that are either currently enrolling people with various cancers or have recently finished enrollment; I wonder what the fate of the overall program will be given the repeated negative results?
At the beginning of this month many pharma and biotech pundits smiled at the 'beware the Ides of March' quips on Twitter, but by the end of March they seem much more accurate than one may realise!
Looking back through the months posts, there were several spectacular phase III flops from Pfizer and Roche, Roche's ocrelizumab and AstraZeneca's cediranib bit the dust, the ODAC meeting on 22nd was brutal for Cell Therapeutics and ChemGenex with neither getting approved, Antisoma's ASA404 crashed on Monday, Merck KGaA are reviewing the EU cardiac data for Erbitux, which may also have implications for BMS and ImClone in the US. Yikes, I could go on…
Let's hope that April and May bring more positive news to talk about.
3 Responses to “Genvec's TNFerade fails in phase III trials for pancreatic cancer”
Sally. Love the blog.
Do you think that there are so many Phase 3 failures because some of these drug companies (particularly underfinanced ones) “push” their drugs through Phase 2 and “hand pick” the candidates that will likely show the best efficacy? Is that even “ethical” from a monetary/shareholder standpoint? Wouldn’t selecting only those patients that would likely show efficacy be misleading especially when you are going to start a Phase 3 trial with a much greater population and randomized? I see a lot of these smaller companies with “good” P2 data as show the N of patients usually sub-50. What would you consider a good number of patients be in a Phase 2 study?
-Craig
I believe that there is a fundamental reason for failing the trial – maybe vectors are just not enough to fight cancer, but you need something more powerful to kill the tumors? In essence, TNFErade is an adenovector that means every cell needs to be infected 1-by-1, which means that tumors are not killed. (Note: There is some “bystander effect” included because of TNF-Alpha, so it is not a pure vector in that sense.) I actually wrote about that, if interested, check at: http://bit.ly/cJO4oY
I was a patient in one of the TNFerade trials (the Atlanta one). Unfortunately, I was randomized to the control arm and received just the chemo and radiation. I was, however, able to have surgery and am getting ready to celebrate the 2-year anniversary of my surgery. I am not sure if the 5FU and IMRT helped, but I’m Not Dead Yet!
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