That was the lead headline screaming from my intelligence database this morning, from several sources. On checking the Pfizer website, to verify the information, I found the following in a terse press release:
trial that evaluated Sutent® (sunitinib malate) plus FOLFIRI
(irinotecan plus infusional 5-fluorouracil and leucovorin) versus
FOLFIRI alone for the first-line treatment of metastatic colorectal
cancer (CRC). The independent Data Monitoring Committee (DMC) found that
the addition of sunitinib to the chemotherapy regimen FOLFIRI would be
unable to demonstrate a statistically significant improvement in the
primary endpoint of progression-free survival (PFS) compared to FOLFIRI
alone, in this study. No new safety issues were identified."
It would therefore seem that small molecule TKI's are not the way to go with this disease given that Novartis' vatalanib also failed in phase III trials of a similar nature. Genentech's Avastin acts differently, targeting the outside of the receptor as a monoclonal antibody.
For Pfizer, this represents another major setback with Sutent after the recent failure in breast cancer studies. Prior to that, the company terminated two other compounds in phase III development, namely, esreboxetine for fibromyalgia and PD 332,334 for generalized
anxiety disorder (GAD) so 2009 is not turning out to be a stellar year for them.
Chasing blockbusters is clearly not all it is cracked up to be.
Contrast Pfizer's experiences with Novartis approach by following the science rather than the money in a Business Week article. Ilaris, an IL-1 inhibitor, has just been approved by the FDA for a rare autoimmune condition known as Muckle Wells disease. This development follows a similar strategy to that taken by the company with the development of Gleevec, ie focusing on the biology of the disease and finding a targeted drug aimed at the critical mutation. The result? Over 90% of children and adults suffering from the immune disorders
that the drug was designed to treat experienced rapid, sustained