Another Setback for Sutent - Analyst Blog

Pfizer Inc.’s (PFE) Sutent faced yet another development setback when the company announced the discontinuation of a phase III study with the candidate for the treatment of liver cancer (advanced hepatocellular carcinoma).

 

Pfizer halted the trial based on a review conducted by an independent Data Monitoring Committee (DMC). The DMC said that a higher number of serious adverse events were observed in the Sutent arm compared with Onyx/Bayer’s (ONXX/BAY) Nexavar (sorafenib). Moreover, Sutent failed to demonstrate superiority or non-inferiority to Nexavar.

 

Despite the setback, Pfizer said that it is continuing to study Sutent for the treatment of other types of cancer. The product is currently in phase III studies for advanced non-small cell lung cancer, advanced castration-resistant prostate cancer and for renal cell carcinoma (as adjuvant therapy).

 

The discontinuation of the liver cancer study is the latest setback faced by Sutent in this year. In March, 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 for 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.

 

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. Approval for additional indications would help boost Sutent revenues significantly.