Pfizer’s (PFE) plans of developing its oncology product Sutent for additional indications faced yet another setback recently with the company announcing the discontinuation of another phase III study with the candidate.
Sutent, in combination with prednisone, was being studied in a phase III trial (SUN 1120) that was being conducted in men suffering from advanced castration-resistant prostate cancer (CRPC) which had progressed even after being treated with a docetaxel-based chemotherapy regimen.
Pfizer’s decision to discontinue this study was based on an interim analysis by an independent Data Monitoring Committee (DMC) which showed that treatment with Sutent and prednisone was not likely to improve overall survival compared to treatment with prednisone alone.
Pfizer reported that no new or unforeseen safety issues were observed in the study. The company intends to further analyze the results which will be presented at an upcoming medical meeting.
Not the First Setback for Sutent
The decision to discontinue the phase III prostate cancer study is the latest setback faced by Sutent this year. Earlier in August, Pfizer had announced disappointing results on the candidate from a late-stage study that was being conducted in patients suffering from non small-cell lung cancer (NSCLC). Results showed that Sutent, when used in combination with Roche’s (RHHBY) Tarceva (erlotinib), failed to demonstrate a statistically significant improvement in overall survival compared to Tarceva alone.
Earlier in April 2010, Pfizer had announced the discontinuation of a phase III liver cancer study. The company halted the trial based on a review conducted by an independent DMC which said that a higher number of serious adverse events were observed in the Sutent arm compared to Onyx/Bayer’s (ONXX/BAYRY) Nexavar (sorafenib). Moreover, Sutent failed to demonstrate superiority or non-inferiority to Nexavar.
Before that, in March 2010, Pfizer had reported disappointing results from two phase III studies of Sutent in advanced breast cancer. The company was evaluating Sutent in combination with docetaxel as a first-line treatment of patients with advanced HER-2 negative breast cancer. However, the study failed to show any improvement in progression-free survival compared with docetaxel alone.
In the second study, Sutent was evaluated with capecitabine in previously treated advanced breast cancer patients. This study also failed to show any significant improvement in progression-free survival compared with capecitabine alone.
Label Expansion Would Boost Sales
The discontinuation of the prostate cancer study is highly disappointing as approval for this indication would have represented significant incremental sales for Sutent.
Sutent is currently approved for the treatment of gastrointestinal stromal tumors (GIST) and metastatic renal cell carcinoma (RCC). The drug has experienced very strong uptake, ending 2009 with revenues up 14% at $964 million. Pfizer said that it is continuing to study Sutent for renal cell carcinoma (as adjuvant therapy). Approval for additional indications would help boost Sutent revenues significantly.
Neutral on Pfizer
We currently have a Neutral recommendation on Pfizer, which is supported by a Zacks #3 Rank (short-term Hold rating). We expect near-term earnings growth to come in the form of cost-cutting and share repurchases.
While the merger with Wyeth provides Pfizer with an attractive biologics platform and some complementary products and businesses, we do not believe they are enough to sustain long-term top-line growth. Longer-term growth will be dependent on the success of drug development. The patent expiration of cholesterol therapy Lipitor in 2011 remains a big concern.
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