Pfizer terminates figitumumab trial in lung cancer for futility

At the end of each day I do a spot check of my Twitter stream to see what's going on.  Imagine my surprise to see the following suddenly appear:

Oh wow, that was the trial we reported on when Pfizer suspended the patient enrollment into the study back in September and notified the clinical trial database, but did not put out a press release about it.  It subsequently turned out that there were more deaths from strokes in the figitumumab arm, suggesting that either the groups were unbalanced for co-morbidities or cardiotoxicity might possibly be an issue.  Previously, we posted a blog expressing concern about the potential for cardiotoxicity with this class of drug.

Here is the actual press release from Pfizer relating to the tweet above.

It seems that the study has now been terminated because the results suggested that adding figitumumab to standard carboplatin plus paclitaxel would not meet the primary endpoint, ie overall survival.  Pfizer were at pains to state that other figitumumab trials were ongoing, including studies in refractory NSCLC, prostate and breast cancers and Ewings sarcoma.

Meanwhile, the IGF-1R inhibitors once looked very promising, but with the termination of Pfizer's trial in NSCLC and Roche/Genentech declining to continue development of Genmab's R1507 due to a portfolio review rather than safety concerns, it will leave a lot of other companies wondering what to do with their IGF-1R inhibitor in development. 

Sometimes though, a particular class of drug can go through a whole pile of different inhibitors until one emerges from the pack triumphantly, as Genentech's VEGF inhibitor, bevacizumab (Avastin), did a few years ago.

2009 has not been a particularly good year for Pfizer Oncology with several Sutent trials being terminated in colorectal cancer, GIST and breast cancer and now the figitumumab lung cancer trial flopping.  Hopefully, they will bounce back in 2010 with their ALK inhibitor in NSCLC.

Fortune sometimes favours the brave.

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• Pfizer Halts Enrollment in Cancer-Drug Trial (online.wsj.com)

Comments

[Sarah Arrow]

Well done Sally, your observations have been proved correct and are being acted upon. What a tremendous scoop for you and your blog. Well done.

Where do Pfizer go from here?

[singh24@gmail.com]

Hello Sally,

What are you thoughts on the Nov002 from Novelos Therapeutics. You might already be following this...they are in SPA & Fast Track Phase 3 trail for NSCLC with results expected next quarter.

thanks,

[MaverickNY]

The cellular redox modulator? Yes, it's interesting and a promising novel approach.

I've been following it in NSCLC and melanoma and Novelos have certainly been in the news in 4Q09. It seems to mitigate hem toxicity associated with some chemotherapy but ultimately, we need to see some more robust data demonstrating an impact on survival.

I'm waiting for more data at ASCO in 2010 before forming a more definitive opinion as the current data is still very early.

[MaverickNY]

Hi Sarah,

Thanks for your kind comment.

Well, for Pfizer they still have other trials ongoing with figitumumab so all hope is not lost yet. They also have a promising ALK/MET inhibitor in development for NSCLC with ELM-ALK mutations that I'm excited about, so hopefully by the ASCO meeting in June we will see how that is progressing.