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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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In the Pipeline

« Antisoma's Phase III Disaster | Main | Animal Studies: Are Too Many Never Published At All? »

March 30, 2010

GeneVec's Pancreatic Cancer Therapy Crashes

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Posted by Derek

Another promising Phase II oncology idea goes into the trench in Phase III: GenVec has been working on a gene-therapy approach ("TNFerade") to induce TNF-alpha expression in tumors. That's not a crazy idea, by any means, although (as with all attempts at gene therapy) getting it to work is extremely tricky.

And so it has proved in this case. It's been a long, hard process finding that out, too. Over the years, the company has looked at TNFerade for metastatic melanoma, soft tissue sarcoma, and other cancers. They announced positive data back in 2001, and had some more encouraging news on pancreatic cancer in 2006 (here's the ASCO abstract on that one). But last night, the company announced that an interim review of the Phase III trial data showed that the therapy was not going to make any endpoint, and the trial was discontinued. Reports are that TNFerade is being abandoned entirely.

This is bad news, of course. I'd very much like gene therapy to turn into a workable mode of treatment, and I'd very much like for people with advanced pancreatic cancer to have something to turn to. (It's truly one of the worst diagnoses in oncology, with a five-year survival rate of around 5%). A lot of new therapeutic ideas have come up short against this disease, and as of yesterday, we can add another one to the list. And we can add another Promising in Phase II / Nothing in Phase III drug to the list, too, the second one this week. . .

Comments (8) + TrackBacks (0) | Category: Biological News | Cancer | Clinical Trials


COMMENTS

1. Old Timer on March 30, 2010 9:10 AM writes...

And it's only Tuesday.

Permalink to Comment

2. Cellbio on March 30, 2010 9:16 AM writes...

The last paragraph of this post is the most accurate, imo, and Genevec deserves a lot of credit for pursuing what could have been a meaningful product for patients. However, were the Ph II data really promising?

I think not. Some methods of analysis showed a trend, in small numbers, other methods of analysis showed no difference btwn treatment arms. So, rather than promising, uncertain with the potential that the trends would reveal themselves as significant differences in larger trials, or not.

Development of TNFerade at a bigco may have gone differently, power in Ph II, different assessment of the "promise" of the Ph II data, adjusted priorities after Ph II data review etc. Not an option for Genevec for business reasons, which creates an urgency for finding out if it really does work, but only after a small Ph II. A very good example of the boom and bust world of biotech, a less good example, imo, of the stark difference between Ph II and Ph III trial results.

Permalink to Comment

3. Morten G on March 30, 2010 11:10 AM writes...

More PDAC: Most lethal of the solid tumors. Fourth leading cause of cancer death in North America. Currently gemcitabine is used to treat and it really doesn't work that well.

Permalink to Comment

4. Evorich on March 30, 2010 2:36 PM writes...

Well at least we'll have to wait until April 23rd until the FDA finally puts the sword through Cell Therapeutics' lymphoma therapy, pixantrone.

Permalink to Comment

5. Jim Hu on March 31, 2010 1:27 AM writes...

I'm wondering if gene therapy for cancer will ever overcome the problem of delivery of the gene to enough of the tumor cells, especially with vectors based on replication-defective adenovirus.

Permalink to Comment

6. Anonymous on March 31, 2010 12:55 PM writes...

I love GenVec's press release which basically blames the tumor type "pancreatic cancer claims another victim" or something like that. More like "poor corporate decision making claims another victim." "Its not us to blame for this phase 3 failure and the decision to pursue question phase 2 results with huge spending for a phase 3, its the disease that's to blame." HA!

Permalink to Comment

7. Evorich on March 31, 2010 4:43 PM writes...

Arqule's, ARQ 197, is looking quite good in PII trials; when used with erlotinib, it showed a 66% improvement in median progression-free survival lung cancer drug.

Is this a proper PII trial that's predictive of PIII results??

Permalink to Comment

8. Dina on June 22, 2010 4:51 PM writes...

Look deeper into the over production of protocols. There is an over kill in the requirements. There is also PI dependence. And the ubiquitous bad fat management choices. One problem employee can bring down a drug.

*The FDA has some slimming down to do before we can get the newest and the best out.

vauge I know.

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