) recently reported disappointing results from a phase III study of
its oncology drug, Torisel. The company is looking to expand
Torisel's label for use in advanced renal cell carcinoma (RCC)
patients whose disease has progressed while on or after being
treated with Sutent.
Results from the phase III INTORSECT (B1771003) study showed
that Torisel failed to achieve the primary endpoint of
progression-free survival (PFS) compared to
) Nexavar (sorafenib). Although PFS was higher in the Torisel arm,
results were not statistically significant.
As far as the secondary endpoint -- overall survival -- was
concerned, patients in the Nexavar arm achieved statistical
significance. Pfizer said that adverse events were in line with the
safety profiles of both Torisel and Nexavar.
Sutent is also a part of Pfizer's oncology portfolio. It is
approved for the treatment of advanced RCC, including metastatic
renal cell carcinoma (mRCC) and gastrointestinal stromal tumors
(GIST) in patients whose disease has progressed while on imatinib
mesylate therapy and in patients who are intolerant to imatinib
Sutent is also approved for the treatment of progressive,
well-differentiated pancreatic neuroendocrine tumors (pNET) in
patients with unresectable locally advanced or metastatic
Torisel is currently approved in the U.S. and other countries
for the treatment of advanced RCC. The product is approved in the
E.U. for the first-line treatment of advanced RCC patients with at
least three of six prognostic risk factors.
The phase III results are disappointing as the label expansion
would have helped boost Torisel sales. Pfizer intends to present
full data from the study shortly at a major medical congress. We
note that Sandoz,
) generic division, and Accord are looking to bring their generic
versions of Torisel to market. Pfizer has filed a patent
infringement lawsuit against the generic players.
We currently have a Neutral recommendation on Pfizer, which
carries a Zacks #3 Rank (short term Hold rating).
BAYER A G -ADR (BAYRY): Free Stock Analysis
NOVARTIS AG-ADR (NVS): Free Stock Analysis
ONYX PHARMA INC (ONXX): Free Stock Analysis
PFIZER INC (PFE): Free Stock Analysis Report
To read this article on Zacks.com click here.