Disappointing Data on Pfizer Drug - Analyst Blog


Pfizer, Inc. ( PFE ) 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 Bayer / Onyx Pharma's ( BAYRY / ONXX ) 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 mesylate therapy.

Sutent is also approved for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in patients with unresectable locally advanced or metastatic disease.

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, Novartis' ( NVS ) 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).

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This article appears in: Investing , Business , Stocks

Referenced Stocks: BAYRY , NVS , ONXX , PFE , PFS



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