Pfizer has retracted another study involving an experimental cancer drug that later failed later-stage trials.
The study, published in Clinical Cancer Research in 2010, looked at which patients might respond to the drug, called figitumumab. Here’s the notice:
The article titled “Molecular Analysis of Non–Small Cell Lung Cancer Identifies Subsets with Different Sensitivity to Insulin-like Growth Factor I Receptor Inhibition,” which was published in the September 15, 2010, issue of Clinical Cancer Research (1), is being retracted at the request of Pfizer, one of the study sponsors, following its investigation into the data from Study 1002, which was a phase II study designed to examine figitumumab, a humanized antibody to insulin growth factor I receptor, in combination with chemotherapy in non–small cell lung cancer.
While conducting database close-out activities, Pfizer became aware that the final data from Study 1002 differed from the results that had been previously reported. The primary efficacy results from the study were published in the Journal of Clinical Oncology (JCO) in May 2009, and the results of certain biomarker analyses performed in connection with it were published in the British Journal of Cancer (BJC) in January 2011 (2, 3). Pfizer provided both journals with new data, and both journals have retracted the affected articles.
These concerns, in combination with the issues that led to the retractions of the figitumumab articles published in JCO and BJC, have led Pfizer to conclude that the reported results from the figitumumab study are unreliable. Thus, Pfizer has requested a retraction of this article. A copy of this notice was sent to the authors prior to publication.
The paper has been cited 36 times, according to Thomson Scientific’s Web of Knowledge.
This is the third retraction involving figitumumab. The first was in the Journal of Clinical Oncology, and the second was in the British Journal of Cancer. The experimental drug, the company told us in 2012,
is a Pfizer-discovered monoclonal antibody that was developed for the treatment of various forms of cancer, including lung, prostate, breast and colorectal cancers and Ewing’s sarcoma.
The corresponding author of all of the studies is Antonio Gualberto, who left Pfizer in 2010 and was most recently at Brown University and Millennium Pharmaceuticals.
Hat tip: Rolf Degen
Were the applications for the phase 3 trials based on problematic data? Did they cause folks some harm? a real shame. pfizer deserves more than a slap on the wrist here. perhaps a 3 year ban on all drug trials with a 5 year probationary period with pfizer funded, government employed oversight would appropriate. stuff like this can’t be allowed to happen. it’s hard enough to trust pharma funded studies without crap like this happening.
I think a lot of studies are funded by pharmaceutical companies. Either they do the research themselves or they fund doctors or graduate students to do the research. In the end, companies (not just pharma) have a vested interest in the research…no surprise there.
Maybe government-funded research is better but no government can pick up the tab for so many studies…
Does this mean they made a mistake in the original publication, or that they published prelim data partway through a study and the final data differed, or did they publish results from one study and then a later study had different results? I can’t tell which.
The way I read it, Pfizer (management, not the researchers) doesn’t know what is wrong but the data from different publications doesn’t agree when it should. If it failed later trials, they likely want to know why, and if there was faking they may be very angry.
Tokyo-based Novartis Pharma K.K. said employees have failed to report up to 10,000 cases of serious side effects caused by its drugs for leukemia and other diseases to an internal department since 2002.
http://www.japantimes.co.jp/news/2014/06/10/national/novartis-side-effects-unreported/#.U5rsJ3b1yt8“
How could Pfizer claim that “figitumumab was likely to be effective” when the revised results showed a progression free survival of 4.5 vs 4.3 months? (That’s six days.) Even the initially reported results were pathetic: a month and a half (admittedly, a third more life than the control group.)
As to the side effects: ANY regimen that includes carboplatin is likely to have intolerable side effects for, probably, half the patients treated.
Once again, I’m diving into an area I’m not qualified to critique (being an ex-family practicioner rather than a treating oncologist) but I think this stinks. Surely the established research community has better ideas for treating a cancer that has such poor survival rates than just combining another monoclonal antibody with carboplatin and paclitaxel? Many victims of NSCLC would rather just go home to die than suffer through a regimen like that to gain an average of 1.5 months (or is it six days?) of longer life.